Daily Self-Weighing for Obesity Management in Primary Care

Study Overview
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Brief Summary
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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.

Official Title
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Daily Self-Weighing for Obesity Management in Primary Care

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Standard Care
* Behavioral: Daily Self-Weighing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19-65 years Body mass index (BMI) 30 - 50 kg/m2 Receives care at one of the participating primary care clinics Resides in one location at least 5 days each week Possesses a smartphone with data plan Wi-Fi or Bluetooth internet connection in home Exclusion Criteria: 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. Unwilling or unable to do any of the following: give informed consent, accept random assignment, attend five measurement assessments Likely to relocate and no longer be seen at UAB primary care in the next 2 years Weight loss ≥5% of body weight in past 6 months (other than postpartum) Weight >180 kg (396lbs) due to the limitation of the scale being used. Current participation in another weight loss study Bariatric surgery or revision in the past two years Prescription weight loss medications within the past 6 months Another household member already participating in the study 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>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. | Behavioral: Standard Care<br>* 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.<br>|
| Experimental: Daily Self-Weighing<br>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. | Behavioral: Daily Self-Weighing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight management, body weight, behavioral, weighing