Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-27 @ 3:08 AM
Study NCT ID:
NCT05104450
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lucas.Donovan@va.gov', 'phone': '206-277-6783', 'title': 'Dr. Lucas Donovan', 'organization': 'Veterans Health Administration'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'We systematically collected adverse events (AE) by body system as part of the the 12- and 21-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition. We also systematically reviewed the electronic health record for discharge summaries among all participants at 12 months, and at 21 month follow-up among those who did not complete follow-up surveys.', 'description': 'Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.', 'eventGroups': [{'id': 'EG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.', 'otherNumAtRisk': 348, 'deathsNumAtRisk': 348, 'otherNumAffected': 126, 'seriousNumAtRisk': 348, 'deathsNumAffected': 1, 'seriousNumAffected': 54}, {'id': 'EG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.', 'otherNumAtRisk': 348, 'deathsNumAtRisk': 348, 'otherNumAffected': 127, 'seriousNumAtRisk': 348, 'deathsNumAffected': 2, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal/Urologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary/Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 21}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal/Urologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary/Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Sleep-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '2.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.04', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in Functional Outcomes of Sleep questionnaire (FOSQ) score between groups.\n\nThe minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'PRIMARY', 'title': 'Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.10', 'spread': '6.75', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '5.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-2.05', 'ciUpperLimit': '-0.06', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to between 9 and 15 months post randomization', 'description': 'The investigators will compare change in weights between intervention and control using clinic weights from VA medical record', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 9-to-15 month post-randomization follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 9-to-15 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Risk Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '3.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.135', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.86', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in cardiovascular risk scores between intervention and control using the non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease (worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Sleep Disturbance Survey Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.34', 'spread': '7.69', 'groupId': 'OG000'}, {'value': '-3.02', 'spread': '6.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-2.01', 'ciUpperLimit': '0.07', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months post randomization', 'description': "The investigators will compare change in sleep disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance (worse outcome).", 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 3 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 3 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Sleep Related Impairment Survey Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.67', 'spread': '8.84', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '7.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.71', 'ciLowerLimit': '-3.83', 'ciUpperLimit': '-1.60', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months post randomization', 'description': "The investigators will compare change in sleep-related impairment between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment (worse outcome).", 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 3 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 3 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure From VA Medical Record', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.22', 'spread': '15.73', 'groupId': 'OG000'}, {'value': '-2.26', 'spread': '15.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.401', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '2.89', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, Charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in systolic blood pressure values between intervention and control.', 'unitOfMeasure': 'millimeters of mercury (mm Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Treatment Usage Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '3.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '-0.04', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months post randomization', 'description': 'The investigators will compare change in daily OSA treatment usage between groups using self-report.', 'unitOfMeasure': 'hours per night', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 3 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 3 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Apnea Hypopnea Index 1b Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.77', 'spread': '14.53', 'groupId': 'OG000'}, {'value': '16.49', 'spread': '17.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.11', 'ciLowerLimit': '-6.37', 'ciUpperLimit': '0.15', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': "Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60).", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'one-time measures: Beta Estimates'}], 'paramType': 'MEAN', 'timeFrame': '12 months post randomization', 'description': 'The investigators will conduct home sleep apnea tests among a subset of patients in each group to compare apnea hypopnea index (a physiologic measure of OSA severity) between groups at 12 months. The apnea hypopnea index measures the number of times per hour of sleep in which an individual stops breathing (apnea) or nearly stops breathing (hypopnea). For this outcome, we will measure apneas and hypopneas using the 1B criteria of the American Academy of Sleep Medicine.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted means for this outcome. The analysis population for adjusted between-group differences includes participants with available covariate data; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Longer-term Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.64', 'spread': '7.71', 'groupId': 'OG000'}, {'value': '-1.98', 'spread': '7.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.469', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '0.78', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to between 18 and 24 months post randomization', 'description': 'The investigators will compare longer-term change in weight between intervention and control using clinic weights from VA medical record', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 18-to-24 month post-randomization follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 18-to-24 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Short-term Change in Sleep-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '2.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.13', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction', 'otherAnalysisDescription': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months post randomization', 'description': 'The investigators will compare short-term change in Functional Outcomes of Sleep questionnaire (FOSQ) between groups. The minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 3 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 3 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Longer-term Change in Sleep-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.29', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '2.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.89', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare longer-term change in Functional Outcomes of Sleep questionnaire (FOSQ) between groups. The minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Global Rating of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.29', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.02', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': "Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60).", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'one-time measures: Beta Estimates'}], 'paramType': 'MEAN', 'timeFrame': '3 months post randomization', 'description': 'The investigators will compare perceived change in symptoms between groups using the single-item patients\' global impression of change (PGI-C). PGI-C has been validated in the context of OSA treatment and asks patients to rate symptom changes on a 7 point scale from "1-Very Much Improved" to "7-Very Much Worse".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted means for this outcome at 3-month follow-up. The analysis population for adjusted between-group differences includes participants with available covariate data; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Change in Self-reported Well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.76', 'spread': '20.92', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '19.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.93', 'ciLowerLimit': '0.91', 'ciUpperLimit': '6.95', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months post randomization', 'description': 'The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 3 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 3 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Risk Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '3.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.93', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare cardiovascular risk scores between intervention and control using the non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease (worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Sleep Disturbance Survey Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.53', 'spread': '8.08', 'groupId': 'OG000'}, {'value': '-3.21', 'spread': '8.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.71', 'ciLowerLimit': '-2.82', 'ciUpperLimit': '-0.59', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post randomization', 'description': "The investigators will compare sleep-related disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey.\n\nIndividuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance (worse outcome).", 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Sleep Disturbance Survey Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.88', 'spread': '7.75', 'groupId': 'OG000'}, {'value': '-3.44', 'spread': '8.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.229', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '0.44', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 21 months post randomization', 'description': "The investigators will compare sleep-related disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey.\n\nIndividuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance (worse outcome).", 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Sleep Related Impairment Survey Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.33', 'spread': '9.04', 'groupId': 'OG000'}, {'value': '-3.96', 'spread': '9.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.51', 'ciLowerLimit': '-3.72', 'ciUpperLimit': '-1.29', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post randomization', 'description': "The investigators will compare sleep-related impairment between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment (worse outcome).", 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Sleep Related Impairment Survey Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.78', 'spread': '9.78', 'groupId': 'OG000'}, {'value': '-4.76', 'spread': '9.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.02', 'ciLowerLimit': '-2.30', 'ciUpperLimit': '0.25', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 21 months post randomization', 'description': "The investigators will compare sleep-related impairment between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment (worse outcome).", 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure From VA Medical Record', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '15.20', 'groupId': 'OG000'}, {'value': '-2.25', 'spread': '15.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.968', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-2.35', 'ciUpperLimit': '2.45', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare change in systolic blood pressure values between intervention and control.', 'unitOfMeasure': 'millimeters of mercury (mm Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure From VA Medical Record', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'spread': '10.57', 'groupId': 'OG000'}, {'value': '-1.44', 'spread': '9.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.218', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '2.17', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in diastolic blood pressure values between intervention and control.', 'unitOfMeasure': 'millimeters of mercury (mm Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure From VA Medical Record', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '10.42', 'groupId': 'OG000'}, {'value': '-1.74', 'spread': '9.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.212', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '2.62', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare change in diastolic blood pressure values between intervention and control.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Treatment Usage Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '3.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.800', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.57', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in daily OSA treatment usage between groups using self-report.', 'unitOfMeasure': 'hours of use', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Treatment Usage Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '3.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.317', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.79', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare change in daily OSA treatment usage between groups using self-report.', 'unitOfMeasure': 'hours of usage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Global Rating of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.05', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '-0.17', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': "Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60).", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'one-time measures: Beta Estimates'}], 'paramType': 'MEAN', 'timeFrame': '12 months post randomization', 'description': 'The investigators will compare perceived change in symptoms between groups using the single-item patients\' global impression of change (PGI-C). PGI-C has been validated in the context of OSA treatment and asks patients to rate symptom changes on a 7 point scale from "1-Very Much Improved" to "7-Very Much Worse".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted means for this outcome at 12-month follow-up. The analysis population for adjusted between-group differences includes participants with available covariate data; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Global Rating of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.91', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '1.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.03', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': "Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60).", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'one-time measures: Beta Estimates'}], 'paramType': 'MEAN', 'timeFrame': '21 months post randomization', 'description': 'The investigators will compare perceived change in symptoms between groups using the single-item patients\' global impression of change (PGI-C). PGI-C has been validated in the context of OSA treatment and asks patients to rate symptom changes on a 7 point scale from "1-Very Much Improved" to "7-Very Much Worse".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted means for this outcome at 21-month follow-up. The analysis population for adjusted between-group differences includes participants with available covariate data; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Change in Self-reported Well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.70', 'spread': '20.73', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '24.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.07', 'ciLowerLimit': '0.86', 'ciUpperLimit': '7.27', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Change in Self-reported Well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.96', 'spread': '21.68', 'groupId': 'OG000'}, {'value': '5.24', 'spread': '23.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.065', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.11', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '6.42', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment-by-time interaction'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Apnea Hypopnea Index 1a Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'OG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.06', 'spread': '16.05', 'groupId': 'OG000'}, {'value': '23.23', 'spread': '19.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.63', 'ciLowerLimit': '-7.11', 'ciUpperLimit': '-0.14', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': "Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\\<60 vs. ≥ 60).", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'one-time measures: Beta Estimates'}], 'paramType': 'MEAN', 'timeFrame': '12 months post randomization', 'description': 'The investigators will conduct home sleep apnea tests among a subset of patients in each group to compare apnea hypopnea index (a physiologic measure of OSA severity) between groups at 12 months. The apnea hypopnea index measures the number of times per hour of sleep in which an individual stops breathing (apnea) or nearly stops breathing (hypopnea). For this outcome, we will measure apneas and hypopneas using the 1A criteria of the American Academy of Sleep Medicine.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigators report here the unadjusted means for this outcome. The analysis population for adjusted between-group differences includes participants with available covariate data; see Statistical Analysis 1 for those results.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'FG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '348'}, {'groupId': 'FG001', 'numSubjects': '348'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}, {'groupId': 'FG001', 'numSubjects': '345'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'BG000'}, {'value': '348', 'groupId': 'BG001'}, {'value': '696', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lifestyle Intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.\n\nThe lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.'}, {'id': 'BG001', 'title': 'Usual Care Control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.03', 'spread': '12.03', 'groupId': 'BG000'}, {'value': '56.38', 'spread': '12.38', 'groupId': 'BG001'}, {'value': '56.20', 'spread': '12.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender, Self-Report', 'categories': [{'title': 'Women', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Men', 'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '285', 'groupId': 'BG001'}, {'value': '556', 'groupId': 'BG002'}]}, {'title': 'Non-binary', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '308', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '610', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '487', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'OSA Severity', 'classes': [{'categories': [{'title': 'OSA Severity-mild', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}, {'title': 'OSA Severity-moderate to severe', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Using sleep studies performed in usual care, we classified individuals as having either mild or moderate-to-severe obstructive sleep apnea (OSA) based on the documented clinical interpretation of the interpreting physician. If the physician did not describe severity in their impression, we classified individuals with an apnea hypopnea index ≥15 events/hour as being moderate-to-severe and all others as mild.', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'title': 'BMI 30-34.9', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}, {'title': 'BMI 35-44.9', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'BMI (Body Mass Index) defined based on clinical weight and height. We classified individuals into categories defined by 30-34.9 vs. 35-44.9 kg/m2.', 'unitOfMeasure': 'Participants'}, {'title': 'Sleep-related impairment t-score <60', 'classes': [{'categories': [{'title': 'Sleep-related impairment t-score <60', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}, {'title': 'Sleep-related impairment t-score >=60', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment T-score. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. We classified individuals based on T-score values of ≥ 60 vs. \\<60. A higher PROMIS T-score represents greater Sleep Related Impairment.", 'unitOfMeasure': 'Participants'}, {'title': 'Charlson Co-Morbidity Index', 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '1.49', 'groupId': 'BG000'}, {'value': '0.82', 'spread': '1.45', 'groupId': 'BG001'}, {'value': '0.79', 'spread': '1.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Charlson Comorbidity Index (CCI). Individuals receive a score based on their diagnosed comorbidities. These scores range from 0-29. Higher scores indicate a greater mortality risk.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rurality/Nonmetropolitan', 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-06', 'size': 1211148, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_008.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-03T13:44', 'hasProtocol': True}, {'date': '2024-06-12', 'size': 371205, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_006.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-13T11:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators will randomly assign participants to one of two groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 696}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2021-10-19', 'resultsFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2021-11-01', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-03', 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sleep-related Quality of Life', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in Functional Outcomes of Sleep questionnaire (FOSQ) score between groups.\n\nThe minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.'}, {'measure': 'Change in Weight', 'timeFrame': 'baseline to between 9 and 15 months post randomization', 'description': 'The investigators will compare change in weights between intervention and control using clinic weights from VA medical record'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Risk Scores', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in cardiovascular risk scores between intervention and control using the non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease (worse outcome).'}, {'measure': 'PROMIS - Sleep Disturbance Survey Change', 'timeFrame': 'baseline to 3 months post randomization', 'description': "The investigators will compare change in sleep disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance (worse outcome)."}, {'measure': 'PROMIS - Sleep Related Impairment Survey Change', 'timeFrame': 'baseline to 3 months post randomization', 'description': "The investigators will compare change in sleep-related impairment between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment (worse outcome)."}, {'measure': 'Systolic Blood Pressure From VA Medical Record', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in systolic blood pressure values between intervention and control.'}, {'measure': 'Treatment Usage Per Day', 'timeFrame': 'baseline to 3 months post randomization', 'description': 'The investigators will compare change in daily OSA treatment usage between groups using self-report.'}, {'measure': 'Apnea Hypopnea Index 1b Criteria', 'timeFrame': '12 months post randomization', 'description': 'The investigators will conduct home sleep apnea tests among a subset of patients in each group to compare apnea hypopnea index (a physiologic measure of OSA severity) between groups at 12 months. The apnea hypopnea index measures the number of times per hour of sleep in which an individual stops breathing (apnea) or nearly stops breathing (hypopnea). For this outcome, we will measure apneas and hypopneas using the 1B criteria of the American Academy of Sleep Medicine.'}, {'measure': 'Longer-term Change in Weight', 'timeFrame': 'baseline to between 18 and 24 months post randomization', 'description': 'The investigators will compare longer-term change in weight between intervention and control using clinic weights from VA medical record'}, {'measure': 'Short-term Change in Sleep-related Quality of Life', 'timeFrame': 'baseline to 3 months post randomization', 'description': 'The investigators will compare short-term change in Functional Outcomes of Sleep questionnaire (FOSQ) between groups. The minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.'}, {'measure': 'Longer-term Change in Sleep-related Quality of Life', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare longer-term change in Functional Outcomes of Sleep questionnaire (FOSQ) between groups. The minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.'}, {'measure': 'Global Rating of Change', 'timeFrame': '3 months post randomization', 'description': 'The investigators will compare perceived change in symptoms between groups using the single-item patients\' global impression of change (PGI-C). PGI-C has been validated in the context of OSA treatment and asks patients to rate symptom changes on a 7 point scale from "1-Very Much Improved" to "7-Very Much Worse".'}, {'measure': 'Change in Self-reported Well-being', 'timeFrame': 'baseline to 3 months post randomization', 'description': 'The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.'}, {'measure': 'Cardiovascular Risk Scores', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare cardiovascular risk scores between intervention and control using the non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease (worse outcome).'}, {'measure': 'PROMIS - Sleep Disturbance Survey Change', 'timeFrame': 'baseline to 12 months post randomization', 'description': "The investigators will compare sleep-related disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey.\n\nIndividuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance (worse outcome)."}, {'measure': 'PROMIS - Sleep Disturbance Survey Change', 'timeFrame': 'baseline to 21 months post randomization', 'description': "The investigators will compare sleep-related disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey.\n\nIndividuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance (worse outcome)."}, {'measure': 'PROMIS - Sleep Related Impairment Survey Change', 'timeFrame': 'baseline to 12 months post randomization', 'description': "The investigators will compare sleep-related impairment between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment (worse outcome)."}, {'measure': 'PROMIS - Sleep Related Impairment Survey Change', 'timeFrame': 'baseline to 21 months post randomization', 'description': "The investigators will compare sleep-related impairment between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment (worse outcome)."}, {'measure': 'Systolic Blood Pressure From VA Medical Record', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare change in systolic blood pressure values between intervention and control.'}, {'measure': 'Diastolic Blood Pressure From VA Medical Record', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in diastolic blood pressure values between intervention and control.'}, {'measure': 'Diastolic Blood Pressure From VA Medical Record', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare change in diastolic blood pressure values between intervention and control.'}, {'measure': 'Treatment Usage Per Day', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in daily OSA treatment usage between groups using self-report.'}, {'measure': 'Treatment Usage Per Day', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare change in daily OSA treatment usage between groups using self-report.'}, {'measure': 'Global Rating of Change', 'timeFrame': '12 months post randomization', 'description': 'The investigators will compare perceived change in symptoms between groups using the single-item patients\' global impression of change (PGI-C). PGI-C has been validated in the context of OSA treatment and asks patients to rate symptom changes on a 7 point scale from "1-Very Much Improved" to "7-Very Much Worse".'}, {'measure': 'Global Rating of Change', 'timeFrame': '21 months post randomization', 'description': 'The investigators will compare perceived change in symptoms between groups using the single-item patients\' global impression of change (PGI-C). PGI-C has been validated in the context of OSA treatment and asks patients to rate symptom changes on a 7 point scale from "1-Very Much Improved" to "7-Very Much Worse".'}, {'measure': 'Change in Self-reported Well-being', 'timeFrame': 'baseline to 12 months post randomization', 'description': 'The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.'}, {'measure': 'Change in Self-reported Well-being', 'timeFrame': 'baseline to 21 months post randomization', 'description': 'The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.'}, {'measure': 'Apnea Hypopnea Index 1a Criteria', 'timeFrame': '12 months post randomization', 'description': 'The investigators will conduct home sleep apnea tests among a subset of patients in each group to compare apnea hypopnea index (a physiologic measure of OSA severity) between groups at 12 months. The apnea hypopnea index measures the number of times per hour of sleep in which an individual stops breathing (apnea) or nearly stops breathing (hypopnea). For this outcome, we will measure apneas and hypopneas using the 1A criteria of the American Academy of Sleep Medicine.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['weight loss', 'lifestyle', 'diet', 'exercise', 'randomized controlled trial'], 'conditions': ['Obesity', 'Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': "Prevalent obesity related conditions like obstructive sleep apnea (OSA) represent an important opportunity to improve population health. OSA reduces quality of life and is associated with greater risk for cardiovascular disease. Although obesity is the single greatest reversible risk factor for OSA, patients with OSA and obesity rarely receive weight loss care to reverse OSA and other serious comorbidities. Efficacy trials reinforce that time and resource intensive lifestyle-based weight loss programs improve weight and physiologic measures of OSA severity (apnea hypopnea index, AHI). However, there are barriers to translating these findings into meaningful gains for population health. To meet these challenges, the investigators propose a pragmatic trial of proactively offering a remote video-based and self-directed lifestyle-based weight loss intervention with remote coaching to patients with OSA. The investigators primary aim is to test the effectiveness of a proactively delivered and pragmatic lifestyle intervention to improve co-primary endpoints of sleep-related quality of life and weight among patients with OSA and obesity. Secondarily, the investigators will compare additional outcomes between groups including cardiovascular risk scores, sleep symptoms, AHI, well-being, and global ratings of change. Finally, the investigators will also conduct an implementation process evaluation informed by the RE-AIM framework to identify barriers and facilitators to widespread implementation.\n\nThe investigators will identify patients with OSA and obesity nationwide (n=696) in VA using data from the VA's Corporate Data Warehouse (CDW), and the investigators will contact potentially eligible patients. After confirming eligibility and consent, the investigators will randomly assign subjects to receive the study's lifestyle intervention or usual care alone. The study uses CDW to assess weight change. Subjects will complete questionnaires at baseline at 3, 12 and 21 months after randomization. The lifestyle intervention in POWER focuses on gradual lifestyle behavior change aimed at improving eating habits and increasing physical activity. It encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.", 'detailedDescription': "1. Objective(s) and Hypotheses:\n\n The investigators' primary aim is to test the effectiveness of a proactively delivered and pragmatic weight loss intervention to improve co-primary endpoints of sleep-related quality of life and weight among Veterans with obstructive sleep apnea (OSA) and obesity.\n\n Secondarily, the investigators will compare additional outcomes between groups including cardiovascular risk scores, sleep symptoms, AHI, well-being, and global ratings of change. The investigators will also conduct an implementation process evaluation informed by the RE-AIM framework to identify predictors and determinants of population uptake of the intervention.\n2. Research Design:\n\n The investigators plan a hybrid type 1 pragmatic randomized controlled trial assessing effectiveness and an implementation process evaluation.\n3. Methodology The investigators will proactively identify patients with OSA and obesity nationwide in VA using data from the CDW (n=696), randomizing patients 1:1 to usual care plus the lifestyle-based weight loss intervention or usual care alone. The investigators will collect primary outcomes at 12 months, but will also collect outcomes at 3 and up to 21 months to assess trends over time.\n4. Findings/Progress to Date:\n\nRecruitment and outcome collection completed, analysis is ongoing and not yet complete."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of obstructive sleep apnea (OSA) on sleep study (sleep provider confirmed)\n* Recent body mass index between 30.0-44.9 kg/m2 and at least one additional plausible BMI in last 12 months\n* Access to DVD player, computer, and/or internet\n* Able to participate fully in all study protocol/procedures including informed consent\n\nExclusion Criteria:\n\n* Inability to speak, read, or understand English\n* Recent or active weight loss interventions including use of prescription weight-loss medications, participation in group or individual weight loss programs provided by trained personnel, and prior bariatric surgery or plans for bariatric surgery during the study period.\n* Expected weight loss because of alternate explanations such as from illness\n* High variability in weight due to fluctuations in volume status (e.g. ascites - liver disease, chronic heart failure)\n* Safety and/or adherence concerns due to severe physical or mental health issues, or life expectancy \\<24 months\n* Pregnant, lactating, or planning to become pregnant during the study period\n* Participation in other intervention studies'}, 'identificationModule': {'nctId': 'NCT05104450', 'acronym': 'POWER', 'briefTitle': 'Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (POWER)', 'orgStudyIdInfo': {'id': 'IIR 20-240'}, 'secondaryIdInfos': [{'id': 'I01HX003319', 'link': 'https://reporter.nih.gov/quickSearch/I01HX003319', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lifestyle intervention', 'description': 'The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.', 'interventionNames': ['Behavioral: lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'usual care control', 'description': 'Participants in this arm will continue with usual care without the lifestyle intervention.'}], 'interventions': [{'name': 'lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'Intervention Arm: Usual Care plus a lifestyle behavior change intervention aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.', 'armGroupLabels': ['lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98108-1532', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Lucas M Donovan, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}