Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-02-22 @ 1:10 AM
Study NCT ID:
NCT02634268
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
INtervention Study In overweiGHT Patients With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'margaret.collins@va.gov', 'phone': '206.764.2085', 'title': 'Margaret Collins', 'organization': 'VA Puget Sound Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.', 'description': 'Adverse events were monitored without regard to the specific Adverse Event Term.', 'eventGroups': [{'id': 'EG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity', 'otherNumAtRisk': 346, 'deathsNumAtRisk': 346, 'otherNumAffected': 95, 'seriousNumAtRisk': 346, 'deathsNumAffected': 4, 'seriousNumAffected': 78}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire', 'otherNumAtRisk': 338, 'deathsNumAtRisk': 338, 'otherNumAffected': 90, 'seriousNumAtRisk': 338, 'deathsNumAffected': 9, 'seriousNumAffected': 75}], 'otherEvents': [{'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary/Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 47, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 67, 'numAffected': 52}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal/Urologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 27, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary/Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 42, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 50, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal/Urologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 338, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Six Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '1071.0', 'spread': '354.1', 'groupId': 'OG000'}, {'value': '1005.9', 'spread': '339.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.3', 'ciLowerLimit': '7.93', 'ciUpperLimit': '76.6', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month six minute walk test distance between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average six minute walk test distance at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'distance walked in six minutes', 'unitOfMeasure': 'feet', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Modified Borg Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.09', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Modified Borg Scale score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average Modified Borg Scale score at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '91.0', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '93.7', 'spread': '17.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.34', 'ciLowerLimit': '-2.33', 'ciUpperLimit': '-0.34', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month body weight between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average body weight at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'body weight', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '0.35', 'ciUpperLimit': '2.60', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average SF-12 PCS at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'scores range from 0-100 with higher scores reflecting better health', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '51.4', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '1.89', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 MCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average SF-12 MCS at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12-months', 'description': 'scores range from 0-100 with higher scores reflecting better health', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Non-laboratory Framingham Risk Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '-0.10', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Framingham Risk Score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average Framingham Risk Score at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'This measure uses non-laboratory-based measures (sex, age, body mass index, systolic blood pressure, use of antihypertensive treatment, smoking status, and diabetes status) to yield a score (cardiovascular disease points) representing 10-year risk of having a cardiovascular problem. Low scores (minimum of -2 for women, -3 for men) indicate low risk. Scores of 21 or higher indicate high risk (30% risk or higher).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '111.3', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '113.1', 'spread': '13.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '0.26', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month waist circumference between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average waist circumference at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'cardiovascular disease risk', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12-months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '129.5', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '128.8', 'spread': '16.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-3.02', 'ciUpperLimit': '1.84', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month systolic blood pressure between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average 12 month systolic blood at 12 months between control and intervention groups'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'indicator of cardiovascular disease risk; higher values indicate higher risk', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '32.7', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.17', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month BMI between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average BMI at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'cardiovascular disease risk', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': "St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '54.9', 'spread': '20.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.25', 'ciLowerLimit': '-4.87', 'ciUpperLimit': '0.36', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Symptom score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average SGRQ-C Symptom score at 12 months between control and intervention groups.', 'otherAnalysisDescription': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': "St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '63.3', 'spread': '25.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.31', 'ciLowerLimit': '-5.19', 'ciUpperLimit': '0.56', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Activity score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average SGRQ-C Activity score at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': "St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '32.8', 'spread': '21.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.72', 'ciLowerLimit': '-5.19', 'ciUpperLimit': '-0.25', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Impact score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average SGRQ-C Impact score at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}, {'type': 'SECONDARY', 'title': "St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '46.1', 'spread': '19.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.42', 'ciLowerLimit': '-4.55', 'ciUpperLimit': '-0.28', 'estimateComment': 'Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.', 'groupDescription': 'Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SGRQ-C Total score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in average SGRQ-C Total score at 12 months between control and intervention groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '346'}, {'groupId': 'FG001', 'numSubjects': '338'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'In-person visit completion = 267 for both groups. Some participants completed only surveys because of Covid-19 restrictions.', 'groupId': 'FG000', 'numSubjects': '287'}, {'comment': 'In-person visit completion = 267 for both groups. Some participants completed only surveys because of Covid-19 restrictions.', 'groupId': 'FG001', 'numSubjects': '291'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '47'}]}]}], 'recruitmentDetails': 'Participants were recruited from 4/28/2017-8/16/2019 from 38 diverse settings across the United States, including rural, urban, and academic medical centers, and Department of Veteran Affairs Health Systems.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '684', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lifestyle Intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity\n\nLifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '66.9', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '67.0', 'spread': '8.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '333', 'groupId': 'BG001'}, {'value': '670', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '527', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-18', 'size': 1220646, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-02T12:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 684}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2015-12-10', 'resultsFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2015-12-15', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-13', 'studyFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six Minute Walk Test', 'timeFrame': '12 months', 'description': 'distance walked in six minutes'}], 'secondaryOutcomes': [{'measure': 'Modified Borg Scale', 'timeFrame': '12 months', 'description': 'Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).'}, {'measure': 'Weight', 'timeFrame': '12 months', 'description': 'body weight'}, {'measure': 'Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)', 'timeFrame': '12 months', 'description': 'scores range from 0-100 with higher scores reflecting better health'}, {'measure': 'Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)', 'timeFrame': '12-months', 'description': 'scores range from 0-100 with higher scores reflecting better health'}, {'measure': 'Non-laboratory Framingham Risk Score', 'timeFrame': '12 months', 'description': 'This measure uses non-laboratory-based measures (sex, age, body mass index, systolic blood pressure, use of antihypertensive treatment, smoking status, and diabetes status) to yield a score (cardiovascular disease points) representing 10-year risk of having a cardiovascular problem. Low scores (minimum of -2 for women, -3 for men) indicate low risk. Scores of 21 or higher indicate high risk (30% risk or higher).'}, {'measure': 'Waist Circumference', 'timeFrame': '12 months', 'description': 'cardiovascular disease risk'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '12 months', 'description': 'indicator of cardiovascular disease risk; higher values indicate higher risk'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': '12 months', 'description': 'cardiovascular disease risk'}, {'measure': "St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score", 'timeFrame': '12 months', 'description': 'Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.'}, {'measure': "St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score", 'timeFrame': '12 months', 'description': 'Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.'}, {'measure': "St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score", 'timeFrame': '12 months', 'description': 'Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.'}, {'measure': "St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score", 'timeFrame': '12 months', 'description': 'Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['randomized controlled trial', 'diet', 'exercise', 'obesity', 'overweight', 'chronic obstructive pulmonary disease', 'lifestyle'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'Obesity', 'Weight Loss', 'Life Style', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '37769182', 'type': 'DERIVED', 'citation': 'Au DH, Gleason E, Hunter-Merrill R, Baron AE, Collins M, Ronneberg C, Lv N, Rise P, Wai TH, Plumley R, Wisniewski SR, Sciurba FC, Kim DY, Simonelli P, Krishnan JA, Wendt CH, Feemster LC, Criner GJ, Maddipati V, Mohan A, Ma J. Lifestyle Intervention and Excess Weight in Chronic Obstructive Pulmonary Disease (COPD): INSIGHT COPD Randomized Clinical Trial. Ann Am Thorac Soc. 2023 Dec;20(12):1743-1751. doi: 10.1513/AnnalsATS.202305-458OC.'}]}, 'descriptionModule': {'briefSummary': 'Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. The investigators are trying to find out if a program proven to help people lose a modest amount of weight and increase their physical activity will improve COPD symptoms for those with a high BMI. The program uses a series of video sessions and self-study handouts focused on healthy eating and increasing physical activity, and encourages participants to monitor their weight, diet, and physical activity for one year. For those who want to, they will be able to work with a health coach to help meet weight and activity goals. We hope that the program will lead to improved exercise tolerance, body weight, dyspnea, generic health-related quality of life, and major cardiovascular risk factors (central obesity by waist circumference, Framingham Risk Score, and blood pressure) through 12 months of follow-up. To be in the study, participants will need to have COPD, high BMI, history of smoking, shortness of breath, and be at least 40 years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40 years or older at time of eligibility screening;\n* Body mass index 25.0-44.9 kg/m2 (also see Figure 2);\n* Smoked more than 10 pack-years of cigarettes;\n* Shortness of breath;\n* COPD;\n* Able to participate fully in all study protocol/procedures including written informed consent process.\n\nExclusion Criteria:\n\n* Inability to speak, read, or understand English;\n* Active weight loss interventions;\n* Expected weight loss because of alternate explanations, such as from illness;\n* Unable to ambulate to weight scale for weight measurement;\n* Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy \\<18 months;\n* Pregnant, lactating, or planning to become pregnant during the study period;\n* Participation in other intervention studies.'}, 'identificationModule': {'nctId': 'NCT02634268', 'acronym': 'INSIGHT COPD', 'briefTitle': 'INtervention Study In overweiGHT Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'Seattle Institute for Biomedical and Clinical Research'}, 'officialTitle': 'INtervention Study In overweiGHT Patients With COPD', 'orgStudyIdInfo': {'id': '1U01HL128868', 'link': 'https://reporter.nih.gov/quickSearch/1U01HL128868', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lifestyle intervention', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity', 'interventionNames': ['Behavioral: Lifestyle Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Participants continue with usual diet and exercise activities as they desire'}], 'interventions': [{'name': 'Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': 'Behavioral lifestyle intervention focused on healthy eating and physical activity', 'armGroupLabels': ['Lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham VA Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham - 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