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| Name | Class |
|---|---|
| Indiana University | OTHER |
| Cornell University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator | 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. |
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| Daily Self-Weighing | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight from baseline to month 6 | Body weight measured to the nearest 0.1 kg using a calibrated electronic scale | 6 months |
| Change in body weight from baseline to month 12 | Body weight measured to the nearest 0.1 kg using a calibrated electronic scale | 12 months |
| Change in body weight from baseline to month 18 | Body weight measured to the nearest 0.1 kg using a calibrated electronic scale | 18 months |
| Change in body weight from baseline to month 24 | Body weight measured to the nearest 0.1 kg using a calibrated electronic scale | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 6 | 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 | Description | Time Frame |
|---|---|---|
| Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 12 | 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 | month 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34082075 | Derived | 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. |
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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.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001835 | Body Weight |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Daily Self-Weighing | Behavioral | 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. |
|
| baseline to month 6 |
| Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 12 | 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. | month 6 to month 12 |
| Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 18 | 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. | month 12 to month 18 |
| Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 24 | 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. | month 18 to month 24 |
| Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 24 |
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 |
| month 24 |
| Mean score on the Eating Disorder Diagnostic Screening form at month 12 | The 22-item Eating Disorder Diagnostic Screening will monitor symptoms of eating disorders | month 12 |
| Mean score on the Eating Disorder Diagnostic Screening form at month 24 | The 22-item Eating Disorder Diagnostic Screening will monitor symptoms of eating disorders | month 24 |
| Mean score on the Body Shape Questionnaire-16A at month 12 | The 16-item Body Shape Questionnaire-16A will monitor symptoms of body image disturbance | month 12 |
| Mean score on the Body Shape Questionnaire-16A at month 24 | The 16-item Body Shape Questionnaire-16A will monitor symptoms of body image disturbance | month 24 |
| Mean score on the Patient Health Questionnaire-8 (PHQ-8) at month 12 | The Patient Health Questionnaire-8 (PHQ-8) will monitor depressive symptoms | month 12 |
| Mean score on the Patient Health Questionnaire-8 (PHQ-8) at month 24 | The Patient Health Questionnaire-8 (PHQ-8) will monitor depressive symptoms | month 24 |
| Healthcare utilization at month 12 assessed by the EuroQOL (EQ-5D-5L) | 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) | baseline to month 12 |
| Healthcare utilization at month 24 assessed by the EuroQOL (EQ-5D-5L) | 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) | month 12 to month 24 |
| D013568 | Pathological Conditions, Signs and Symptoms |