Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT04044794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-14
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Self-Weighing for Obesity Management in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 396}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2019-08-02', 'studyFirstSubmitQcDate': '2019-08-02', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 12', 'timeFrame': 'month 12', 'description': "Self-efficacy (i.e., confidence in one's ability to execute the behaviors required to meet a goal) for healthy eating, physical activity, and weight loss will be assessed with the 12-item Self-Efficacy for Weight Loss Trials Scale"}, {'measure': 'Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 24', 'timeFrame': 'month 24', 'description': "Self-efficacy (i.e., confidence in one's ability to execute the behaviors required to meet a goal) for healthy eating, physical activity, and weight loss will be assessed with the 12-item Self-Efficacy for Weight Loss Trials Scale"}, {'measure': 'Mean score on the Eating Disorder Diagnostic Screening form at month 12', 'timeFrame': 'month 12', 'description': 'The 22-item Eating Disorder Diagnostic Screening will monitor symptoms of eating disorders'}, {'measure': 'Mean score on the Eating Disorder Diagnostic Screening form at month 24', 'timeFrame': 'month 24', 'description': 'The 22-item Eating Disorder Diagnostic Screening will monitor symptoms of eating disorders'}, {'measure': 'Mean score on the Body Shape Questionnaire-16A at month 12', 'timeFrame': 'month 12', 'description': 'The 16-item Body Shape Questionnaire-16A will monitor symptoms of body image disturbance'}, {'measure': 'Mean score on the Body Shape Questionnaire-16A at month 24', 'timeFrame': 'month 24', 'description': 'The 16-item Body Shape Questionnaire-16A will monitor symptoms of body image disturbance'}, {'measure': 'Mean score on the Patient Health Questionnaire-8 (PHQ-8) at month 12', 'timeFrame': 'month 12', 'description': 'The Patient Health Questionnaire-8 (PHQ-8) will monitor depressive symptoms'}, {'measure': 'Mean score on the Patient Health Questionnaire-8 (PHQ-8) at month 24', 'timeFrame': 'month 24', 'description': 'The Patient Health Questionnaire-8 (PHQ-8) will monitor depressive symptoms'}, {'measure': 'Healthcare utilization at month 12 assessed by the EuroQOL (EQ-5D-5L)', 'timeFrame': 'baseline to month 12', 'description': 'Self-reported use of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and associated costs will be collected using the EuroQOL (EQ-5D-5L)'}, {'measure': 'Healthcare utilization at month 24 assessed by the EuroQOL (EQ-5D-5L)', 'timeFrame': 'month 12 to month 24', 'description': 'Self-reported use of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and associated costs will be collected using the EuroQOL (EQ-5D-5L)'}], 'primaryOutcomes': [{'measure': 'Change in body weight from baseline to month 6', 'timeFrame': '6 months', 'description': 'Body weight measured to the nearest 0.1 kg using a calibrated electronic scale'}, {'measure': 'Change in body weight from baseline to month 12', 'timeFrame': '12 months', 'description': 'Body weight measured to the nearest 0.1 kg using a calibrated electronic scale'}, {'measure': 'Change in body weight from baseline to month 18', 'timeFrame': '18 months', 'description': 'Body weight measured to the nearest 0.1 kg using a calibrated electronic scale'}, {'measure': 'Change in body weight from baseline to month 24', 'timeFrame': '24 months', 'description': 'Body weight measured to the nearest 0.1 kg using a calibrated electronic scale'}], 'secondaryOutcomes': [{'measure': 'Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 6', 'timeFrame': 'baseline to month 6', 'description': 'A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.'}, {'measure': 'Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 12', 'timeFrame': 'month 6 to month 12', 'description': 'A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.'}, {'measure': 'Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 18', 'timeFrame': 'month 12 to month 18', 'description': 'A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.'}, {'measure': 'Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 24', 'timeFrame': 'month 18 to month 24', 'description': 'A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['weight management', 'body weight', 'behavioral', 'weighing'], 'conditions': ['Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '34082075', 'type': 'DERIVED', 'citation': 'Dutton GR, Kinsey AW, Howell CR, Pisu M, Dobelstein AE, Allison DB, Xun P, Levitsky DA, Fontaine K. The daily Self-Weighing for Obesity Management in Primary Care Study: Rationale, design and methodology. Contemp Clin Trials. 2021 Aug;107:106463. doi: 10.1016/j.cct.2021.106463. Epub 2021 May 31.'}]}, 'descriptionModule': {'briefSummary': 'Many adults with obesity continue to gain weight even though they do not want to. This project will test the effects of a primary care intervention in which people with obesity receive an electronic scale and recommendations to weigh themselves daily. This will help us understand whether daily self-weighing might be a way to prevent continued weight gain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19-65 years\n* Body mass index (BMI) 30 - 50 kg/m2\n* Receives care at one of the participating primary care clinics\n* Resides in one location at least 5 days each week\n* Possesses a smartphone with data plan\n* Wi-Fi or Bluetooth internet connection in home\n\nExclusion Criteria:\n\n* Pregnancy or anticipating pregnancy during study duration. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.\n* Unwilling or unable to do any of the following: give informed consent, accept random assignment, attend five measurement assessments\n* Likely to relocate and no longer be seen at UAB primary care in the next 2 years\n* Weight loss ≥5% of body weight in past 6 months (other than postpartum)\n* Weight \\>180 kg (396lbs) due to the limitation of the scale being used.\n* Current participation in another weight loss study\n* Bariatric surgery or revision in the past two years\n* Prescription weight loss medications within the past 6 months\n* Another household member already participating in the study\n* Potential participants living farther than 50 miles driving distance from UAB will be excluded from the study. It is expected that those living farther away will be more difficult to retain as study participants.'}, 'identificationModule': {'nctId': 'NCT04044794', 'acronym': 'SWOP', 'briefTitle': 'Daily Self-Weighing for Obesity Management in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Daily Self-Weighing for Obesity Management in Primary Care', 'orgStudyIdInfo': {'id': 'R01DK118939', 'link': 'https://reporter.nih.gov/quickSearch/R01DK118939', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'Participants randomly assigned to this arm will receive standardized weight management educational materials plus a monetary gift of $60 that can be used to purchase health-promoting supplies to support weight management.', 'interventionNames': ['Behavioral: Standard Care']}, {'type': 'EXPERIMENTAL', 'label': 'Daily Self-Weighing', 'description': "Participants randomly assigned to this arm will receive standardized weight management educational materials plus a commercially available wireless scale. Participants will be instructed to weigh daily and view their weight on the scale's digital display.", 'interventionNames': ['Behavioral: Daily Self-Weighing']}], 'interventions': [{'name': 'Standard Care', 'type': 'BEHAVIORAL', 'description': 'Standard care includes standardized educational materials to promote self-management of body weight along with provision of $60 for participants to purchase supplies or equipment to facilitate weight management.', 'armGroupLabels': ['Standard Care']}, {'name': 'Daily Self-Weighing', 'type': 'BEHAVIORAL', 'description': "Participants will receive a wireless digital scale and will be asked to keep the scale in their home, weigh daily at the same time, and view their weight trajectory on the scale's digital display.", 'armGroupLabels': ['Daily Self-Weighing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'The PI will ensure all publications that result from project-related data will comply with the NIH public access policy and develop a system by which study data may be shared with other investigators within the scientific community. With UAB IRB permission, PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified individuals/organizations. PI will keep a record of all individuals/res. teams who request/receive a copy of the data. Interested investigators will be asked to complete a request form stating specific aims of the analyses, analytic plan, available resources, proposed timeline, and goals. PI and team will review these requests to determine whether proposed analyses constitute significant exploration of the data, team has resources to complete request, and data will be adequately protected and managed. If any issues are problematic, PI and team will attempt to negotiate a fair resolution with investigators and NIH staff.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indiana University', 'class': 'OTHER'}, {'name': 'Cornell University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gareth R. Dutton PhD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}