Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-28 @ 7:11 PM
Study NCT ID:
NCT03104205
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2017-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MOWI Home-Based Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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': 'D001836', 'term': 'Body Weight Changes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.a.batsis@hitchcock.org', 'phone': '6036505000', 'title': 'John A. Batsis', 'organization': 'Dartmouth-Hitchcock'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months - duration of the intervention', 'eventGroups': [{'id': 'EG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 14, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Musculoskeletal Pain', 'notes': 'Shoulder, Knee, Kneck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'notes': 'emergency room visit for atrial fibrillatino', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '7.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.'}, {'type': 'PRIMARY', 'title': 'Change in 30 Second Sit-to-Stand (STS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'STS measures lower limb strength - change represented as repetitions.', 'unitOfMeasure': 'repetitions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluating those completing the intervention n=44'}, {'type': 'PRIMARY', 'title': 'Change in Six-Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'spread': '77.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.'}, {'type': 'PRIMARY', 'title': 'Change in Gait Speed (Meters Per Second)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (a significant change is considered 0.1 meters per second).', 'unitOfMeasure': 'meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.'}, {'type': 'PRIMARY', 'title': 'Change in Late-Life Function and Disability Instrument (LLFDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '4.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. For this instrument we use only the 32-item function and scores are scaled. Minimum 0, Maximum 100. Higher scores indicate higher levels of function', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluating those completing the intervention n=44'}, {'type': 'SECONDARY', 'title': 'Behavioral Activation (Patient Activation Measure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '69.4', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': '26-weeks', 'categories': [{'measurements': [{'value': '77.0', 'spread': '14.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and follow-up at 26-weeks', 'description': 'Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors \\& outcomes. Score ranges from 0 to 100, higher scores indicate higher activation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjective data is analyzed baseline and follow-up of participants n=53'}, {'type': 'SECONDARY', 'title': 'Subjective Health Status (PROMIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'title': 'Physical Function', 'categories': [{'measurements': [{'value': '3.63', 'spread': '4.89', 'groupId': 'OG000'}]}]}, {'title': 'Mental Function', 'categories': [{'measurements': [{'value': '2.65', 'spread': '5.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. A score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better health.', 'unitOfMeasure': 'Change in the T score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'these are completers'}, {'type': 'SECONDARY', 'title': 'Change in Weight in kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Change in weight in kg', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluating those completing the intervention n=44'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI) in kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Change in body mass index (BMI) in kg/m\\^2', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluating those completing the intervention n=44'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference in cm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Change in waist circumference in cm', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.'}, {'type': 'SECONDARY', 'title': 'Steps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '4078', 'spread': '3819', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Fitibit will assess steps', 'unitOfMeasure': 'steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluating those completing the intervention n=44'}, {'type': 'SECONDARY', 'title': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) -', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'title': 'low intensity caloric expenditure per week (ckal/week)', 'categories': [{'measurements': [{'value': '312.69', 'spread': '1323.67', 'groupId': 'OG000'}]}]}, {'title': 'moderate intensity caloric expenditure (Kcal/wk)', 'categories': [{'measurements': [{'value': '5.05', 'spread': '10.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.', 'unitOfMeasure': 'Kcal/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'These are the completers of the intervention'}, {'type': 'SECONDARY', 'title': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'title': 'Not Exercising Frequency (frequency per week)', 'categories': [{'measurements': [{'value': '-2.93', 'spread': '15.06', 'groupId': 'OG000'}]}]}, {'title': 'Low intensity frequency (frequency per week)', 'categories': [{'measurements': [{'value': '2.36', 'spread': '7.90', 'groupId': 'OG000'}]}]}, {'title': 'moderate intensity frequency (frequency per week)', 'categories': [{'measurements': [{'value': '2.68', 'spread': '5.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.', 'unitOfMeasure': 'exercise frequency per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'These are the completers of the intervention'}, {'type': 'SECONDARY', 'title': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'classes': [{'title': 'Not exercise duration (hours per week)', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '11.16', 'groupId': 'OG000'}]}]}, {'title': 'low intensity duration (hours/week)', 'categories': [{'measurements': [{'value': '1.64', 'spread': '5.35', 'groupId': 'OG000'}]}]}, {'title': 'moderate intensity duration (hours per week)', 'categories': [{'measurements': [{'value': '1.65', 'spread': '4.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.', 'unitOfMeasure': 'exercise hours per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'These are the completers of the intervention'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MOWI Group', 'description': 'Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Evaluate Home-based MOWI', 'description': "Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function.\n\nEvaluate home-based MOWI: MOWI will be delivered via video-conferencing in the subject's home in a 3x per week, 26-week program from the coordinating center. It will include an individual dietician-led weekly nutrition session; 2x/week physical therapist-led group exercise session; and remote fitness device monitoring. We plan 5 cohorts of 8 subjects (n=40). In-person Research Assistant-led assessments will occur at 0, 8, 16 and 26 weeks. Recruitment, screening, selection criteria, and usability parallel Aim 2 (NCT03104192)."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.9', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-03', 'size': 813989, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-05-23T09:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single arm pilot intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2017-04-03', 'resultsFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-17', 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Grip Strength', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.'}, {'measure': 'Change in 30 Second Sit-to-Stand (STS)', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'STS measures lower limb strength - change represented as repetitions.'}, {'measure': 'Change in Six-Minute Walk Test (6MWT)', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m'}, {'measure': 'Change in Gait Speed (Meters Per Second)', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (a significant change is considered 0.1 meters per second).'}, {'measure': 'Change in Late-Life Function and Disability Instrument (LLFDI)', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. For this instrument we use only the 32-item function and scores are scaled. Minimum 0, Maximum 100. Higher scores indicate higher levels of function'}], 'secondaryOutcomes': [{'measure': 'Behavioral Activation (Patient Activation Measure)', 'timeFrame': 'baseline and follow-up at 26-weeks', 'description': 'Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors \\& outcomes. Score ranges from 0 to 100, higher scores indicate higher activation.'}, {'measure': 'Subjective Health Status (PROMIS)', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. A score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better health.'}, {'measure': 'Change in Weight in kg', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Change in weight in kg'}, {'measure': 'Change in Body Mass Index (BMI) in kg/m^2', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Change in body mass index (BMI) in kg/m\\^2'}, {'measure': 'Change in Waist Circumference in cm', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Change in waist circumference in cm'}, {'measure': 'Steps', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'Fitibit will assess steps'}, {'measure': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) -', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.'}, {'measure': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.'}, {'measure': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week', 'timeFrame': 'Change between baseline and follow-up at 26-weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['frail elderly', 'telemedicine', 'obesity', 'rural health', 'health promotion', 'weight loss'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '33435877', 'type': 'DERIVED', 'citation': 'Batsis JA, Petersen CL, Clark MM, Cook SB, Kotz D, Gooding TL, Roderka MN, Al-Nimr RI, Pidgeon D, Haedrich A, Wright KC, Aquila C, Mackenzie TA. Feasibility and acceptability of a technology-based, rural weight management intervention in older adults with obesity. BMC Geriatr. 2021 Jan 12;21(1):44. doi: 10.1186/s12877-020-01978-x.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/show/NCT03085589', 'label': 'Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development \\& Validation'}, {'url': 'https://clinicaltrials.gov/ct2/show/NCT03041831', 'label': 'Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment'}, {'url': 'https://clinicaltrials.gov/show/NCT03104192', 'label': 'Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.', 'detailedDescription': "The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. Conventional weight loss programs have the potential to reduce body fat, but are difficult to access for older obese adults due to transportation and mobility challenges. The overarching goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology assisted wellness intervention for older adults with obesity.\n\nStudy Timeline:\n\nSeptember 2018 to April 2021:\n\nGoal: Conduct a study of improving weight and physical function in older adults with obesity at home using video-conferencing. An mHealth obesity wellness intervention (MOWI) will integrate a fitness device with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session performed in a person's home.\n\nParticipation Duration: Three times weekly for 6 months. We shall also have participants return to the center once monthly"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥65 years\n* Body Mass Index (BMI) ≥ 30kg/m\\^2 OR Waist circumference ≥88cm in females or ≥102cm in males\n* Have Wi-Fi high speed internet\n* Able to obtain medical clearance from doctor\n* Have less than a 5% weight loss in past 6 months\n* No advanced co-morbidity\n* No exercise restrictions\n* Not involved in other research studies that may interfere with participation\n\nExclusion Criteria:\n\n* Severe mental or life-threatening illness\n* Dementia\n* Substance use\n* History of bariatric surgery\n* Suicidal ideation\n* Unable to perform measures\n* Reside in nursing home\n* No advanced co-morbidity\n* No exercise restrictions\n* Not involved in other research studies that may interfere with participation'}, 'identificationModule': {'nctId': 'NCT03104205', 'briefTitle': 'MOWI Home-Based Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot', 'orgStudyIdInfo': {'id': 'D16182_3'}, 'secondaryIdInfos': [{'id': 'K23AG051681', 'link': 'https://reporter.nih.gov/quickSearch/K23AG051681', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evaluate home-based MOWI', 'description': 'Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function.', 'interventionNames': ['Behavioral: Evaluate home-based MOWI']}], 'interventions': [{'name': 'Evaluate home-based MOWI', 'type': 'BEHAVIORAL', 'description': "MOWI will be delivered via video-conferencing in the subject's home in a 3x per week, 26-week program from the coordinating center. It will include an individual dietician-led weekly nutrition session; 2x/week physical therapist-led group exercise session; and remote fitness device monitoring. We plan 5 cohorts of 8 subjects (n=40). In-person Research Assistant-led assessments will occur at 0, 8, 16 and 26 weeks. Recruitment, screening, selection criteria, and usability parallel Aim 2 (NCT03104192).", 'armGroupLabels': ['Evaluate home-based MOWI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'John A Batsis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center / Dartmouth Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth', 'investigatorFullName': 'John A. Batsis, MD', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}