Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT06985251
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2025-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CommitFit App to Facilitate Health Behavior Change in Clinic Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-25', 'size': 238575, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-25T17:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '%logged', 'timeFrame': 'Baseline to 4 months', 'description': 'How of then user logged a health behavior goal in CommitFit app divided by how often they could have logged. Users can log up to 2 goals per day, each day.'}, {'measure': 'blood pressure', 'timeFrame': 'Baseline to 4 months', 'description': 'blood pressure in adolescents and caregivers'}, {'measure': 'GAD7', 'timeFrame': 'Baseline to 4 months', 'description': 'anxiety in adolescents'}, {'measure': 'PedQL', 'timeFrame': 'Baseline to 4 months', 'description': 'Pediatric Quality of Life in adolescents'}, {'measure': 'Reasons why I think about being healthy', 'timeFrame': 'Baseline to 4 months', 'description': 'Health behavior motivation survey in adolescent'}, {'measure': 'CommitFit surveys', 'timeFrame': 'Baseline to 4 months', 'description': 'Surveys developed by the research team to evaluate CommitFit app including behavior economics, gamification, app use survey, and commercialization in adolescents and caregivers'}], 'primaryOutcomes': [{'measure': 'BMI percentile', 'timeFrame': 'Baseline to 4 months', 'description': 'Change in BMI percentile for adolescents'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'Baseline to 4 months', 'description': 'Change in BMI in adult caregivers'}, {'measure': '%goal achieved', 'timeFrame': 'Baseline to 4 months', 'description': 'Number of times the user achieved their self-selected health behavior goal divided by the number of possible times they could have achieved health behavior goal. Users can achieve up to 2 goals per day, every day.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mHealth', 'obesity', 'adolescent', 'parent', 'caregiver', 'financial incentives', 'behavior modification', 'user engagement'], 'conditions': ['Overweight Adolescents']}, 'referencesModule': {'references': [{'pmid': '39255473', 'type': 'BACKGROUND', 'citation': 'Braddock A, Ghosh P, Montgomery E, Lim C, Ghosh J, Henry N, Popescu M, Kimchi K, Guo C, Bosworth KT, Koopman RJ. Effectiveness of an mHealth App That Uses Financial Incentives and Gamification to Promote Health Behavior Change in Adolescents and Caregivers: Protocol for a Clinic-Based Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 10;13:e63505. doi: 10.2196/63505.'}, {'pmid': '41211016', 'type': 'DERIVED', 'citation': 'Henry N, Montgomery E, Ghosh P, Bosworth KT, Lim C, Ghosh J, Popescu M, Kimchi K, Guo C, Smith J, Braddock A. Caregiver inclusion influence on adolescent acceptance and engagement of an mHealth app, a randomized controlled trial. Mhealth. 2025 Oct 29;11:57. doi: 10.21037/mhealth-24-97. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'We conducted a 3-month RCT with 30 adolescents (aged 13-15 years) and their caregivers to evaluate the effectiveness of the novel mHealth app "CommitFit", which uses gamification to motivate users to log and achieve health behavior goals. The RCT had three arms: (1) CommitFit only users, (2) CommitFit$, adolescents were paid $0.05 for each point they earned, and (3) Control. Software analytics, surveys, BMI, and blood pressure were evaluated at baseline, 3 months, and 4 months.', 'detailedDescription': 'We will recruit 30 adolescents and 30 caregivers to beta test CommitFit. The study will be limited to one participating adolescent and one of their caregivers. There will be three groups in the study: 1) Control 2) CommitFit and 3) CommitFit$.\n\nAll participants will be required to complete a screening survey at the beginning of the study. The eligible participants will be contacted via email/ phone and will give their consent after taking the screening survey, and then they will take the baseline demographic survey for their adolescents and themselves.\n\nAfter the participants in the CommitFit and CommitFit$ groups download the app, they will be shown how to pick a health behavior (fruits/vegetables, water, decreased sugary beverages, physical activity, sleep) and then set a goal and a time period to work on their goal. They will receive a daily reminder to log their health behaviors. At the end of their goal period, they will be rewarded with points for logging behaviors and successfully achieving their goals. Points will be used to rank the participant on the leaderboard using the username that they registered with. Users can also use points to unlock gear for their avatar in the gear store. Control group participants will receive email handouts with healthy lifestyle tips which they could use if they choose to. They will not use the CommitFit app. All participants will be compensated through eGift cards.\n\nSoftware analytics will be utilized to evaluate how the app was used (frequency of goals set and behaviors logged), duration of use, etc., to evaluate app features and gamification techniques. We will evaluate changes in health behaviors using online surveys, and measure health metrics (height and weight which will be used to calculate Body Mass Index (BMI), and blood pressure) in the clinic.\n\nWe will have the adolescents take 7 surveys-GAD7, PedQL, Reasons why I think about being healthy, Behavior economics survey, Gamification Survey, CommitFit App Survey, and Commercialization Survey (CommitFit and CommitFit$ only for use surveys). Similarly, we will have the caregivers take 4 surveys Gamification Survey, CommitFit App Survey, Behavior economics survey, and Commercialization Survey for caregiver subject. In the control group, adolescents will only take 4 surveys- GAD7, PedQL, Reasons why I think about being healthy, and Behavior economics survey. Caregivers in the control group will take only the Behavioral Economic survey. All participants will take the surveys at the beginning of the study, after end of 3rd month, and at the end of the 4th month (follow-up visit). Weight, height and blood pressure from all adolescents and their caregivers will also be collected at the clinical site. All participants completed the 5-10 minute paper exit survey and interview at their final 4-month clinic visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: speak English fluently, read at the 6th grade level or higher, and be proficient with smart phone app use to participate. Caregivers much bet at least 18 years or older. No baseline weight criteria.\n\n\\-\n\nExclusion Criteria: severe mental health disorders (other than mild or controlled anxiety and/or depression), intellectual disabilities, or eating disorders via a screening survey\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06985251', 'briefTitle': 'CommitFit App to Facilitate Health Behavior Change in Clinic Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'CommitFit App to Facilitate Health Behavior Change in Clinic Adolescents', 'orgStudyIdInfo': {'id': '2092610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CommitFit$', 'description': 'Adolescents in CommitFit$ were paid $0.05 for each point they earned when using app', 'interventionNames': ['Other: gamified mHealth app with financial incentives']}, {'type': 'EXPERIMENTAL', 'label': 'CommitFit', 'description': 'Caregivers and Adolescents using CommitFit app without additional financial incentives', 'interventionNames': ['Other: gamified mHealth lifestyle app']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Attention, wait-list controls were emailed monthly healthy lifestyle handouts and were allowed to download CommitFit after 4 month study period ended.', 'interventionNames': ['Other: Attention Control']}], 'interventions': [{'name': 'gamified mHealth lifestyle app', 'type': 'OTHER', 'description': 'The CommitFit mHealth app uses gamification techniques to motivate adolescents and caregivers to set and achieve health behavior goals (eat more fruits or vegetables, increase water intake, decrease sugary beverage intake, increase physical activity, or increase overnight sleep). Users are ranked on leaderboard based on their points and can team up with caregivers on a team leaderboard.', 'armGroupLabels': ['CommitFit']}, {'name': 'Attention Control', 'type': 'OTHER', 'description': 'Standard of care healthy lifestyle handouts were emailed monthly to control families.', 'armGroupLabels': ['Control']}, {'name': 'gamified mHealth app with financial incentives', 'type': 'OTHER', 'description': 'The CommitFit mHealth app uses gamification techniques to motivate adolescents and caregivers to set and achieve health behavior goals (eat more fruits or vegetables, increase water intake, decrease sugary beverage intake, increase physical activity, or increase overnight sleep). Users are ranked on leaderboard based on their points and can team up with caregivers on a team leaderboard. CommitFit$ adolescents received an extra $0.05 for each point they earned in the app.', 'armGroupLabels': ['CommitFit$']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'South Providence Medical Park', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}]}, 'ipdSharingStatementModule': {'url': 'https://mospace.umsystem.edu/xmlui/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Start date will be upon publication of primary outcomes, anticipated to be 1/1/2026. There will be no end date as deidentified data will be available permanently through the data repository at the University of Missouri (MOspace Institutional Repository)', 'ipdSharing': 'YES', 'description': 'The final dataset will include survey data, analytic data generated from the mHealth CommitFit app software, anthropometrics (height, weight, blood pressure, waist circumference), and survey data. To protect the identities of participants, all data will be deidentified before final storage and sharing.', 'accessCriteria': 'All data will be shared within IRB and HIPAA-approved parameters. The PI will monitor and restrict access of identified data to IRB-approved staff. Deidentified data submitted to MOspace will be publicly accessible'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Amy Braddock', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}