FoodRx for Obesity Treatment

Study Overview
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Brief Summary
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This study is a 3-group, parallel design, randomized controlled trial (RCT) in 105 adults with obesity and food insecurity that will compare BWL-Alone (including standard-of-care referral and connection with community food resources; n=35) to BWL plus food supplementation with either food vouchers (BWL+VOUCHER; n=35) or home-delivered, medically tailored groceries consistent with BWL recommendations (BWL+HOME; n=35). All groups will have BWL treatment provided for 24 weeks per clinical guidelines. Food vouchers and HOME will be provided for 24 weeks of treatment. Assessments will be conducted at baseline, and weeks 12 and 24.

Official Title
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Food Supplementation Interventions to Improve Weight Loss for Adults With Food Insecurity and Obesity

Conditions
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Obesity, Food Insecurity

Intervention / Treatment
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* Behavioral: BWL+VOUCHER
* Behavioral: BWL+HOME
* Behavioral: Behavioral weight loss counseling (BWL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Age >18 years BMI >30 kg/m2 at screening visit Screening positive for food insecurity using a score of >3 on the 10-item US Adult Food Security Survey Module109 Completion of baseline assessments Ability to engage in physical activity (i.e., can walk at least 2 blocks) Willing and able to provide pictures of food receipts to study team (or mail actual receipts) Ability to reliably receive packages at a consistent location in a timely manner Telephone or internet service to communicate with study staff For females of reproductive potential: agreement to use of highly effective contraception for during study participation Exclusion Criteria: Serious medical conditions (e.g., type 1 or type 2 diabetes, renal failure) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations Significant psychiatric conditions (e.g., active substance abuse, schizophrenia) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations Breastfeeding, pregnant or planning pregnancy in the next 6 months Planned move from the Philadelphia area in the next 6 months Weight loss of >5 kg in the previous 90 days Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg) Previous or planned obesity treatment with surgery (excluding lap band if removed for >1 year) or a weight-loss device Use of prescription or over the counter medications for chronic weight management in the past 3 months Household member already participating in study due to potential contamination effects Lack of stable residence and ability to store and prepare food

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Behavioral weight loss counseling (BWL) alone<br>BWL counseling alone | Behavioral: Behavioral weight loss counseling (BWL)<br>* The behavioral weight loss program consists of 14 individual lifestyle counseling sessions provided over 24 weeks. Each session will be approximately 15-20 minutes. Visits will be scheduled weekly for the first 4 weeks (weeks 1, 2, 3, and 4) and every-other week from weeks 6-24 (weeks 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24). The sessions will provide behavioral, dietary, and physical counseling.<br>|
| Experimental: BWL+VOUCHER<br>BWL counseling and gift cards to grocery stores | Behavioral: BWL+VOUCHER<br>* This group will receive the BWL program as well as food vouchers, in the form of grocery store gift cards. Participants will be allowed to select to receive gift cards to a grocery store or supermarket from a pre-determined list of stores. Gift cards worth $40 will be emailed or mailed to every 2 weeks after the BWL session.<br>Behavioral: Behavioral weight loss counseling (BWL)<br>* The behavioral weight loss program consists of 14 individual lifestyle counseling sessions provided over 24 weeks. Each session will be approximately 15-20 minutes. Visits will be scheduled weekly for the first 4 weeks (weeks 1, 2, 3, and 4) and every-other week from weeks 6-24 (weeks 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24). The sessions will provide behavioral, dietary, and physical counseling.<br>|
| Experimental: BWL+HOME<br>BWL counseling and home-delivered boxes of groceries | Behavioral: BWL+HOME<br>* This group will receive the BWL program as well as home-delivered boxes of groceries of low-energy density foods conducive to weight management guidelines. Groceries will include shelf-stable and perishable products like lean meats, fresh vegetables, and fruits. Every 2 weeks, participants assigned to this group will be allowed to select a choice of one of 4 boxes with slightly varied contents. Each box will have approximately $40 worth of groceries.<br>Behavioral: Behavioral weight loss counseling (BWL)<br>* The behavioral weight loss program consists of 14 individual lifestyle counseling sessions provided over 24 weeks. Each session will be approximately 15-20 minutes. Visits will be scheduled weekly for the first 4 weeks (weeks 1, 2, 3, and 4) and every-other week from weeks 6-24 (weeks 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24). The sessions will provide behavioral, dietary, and physical counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent initial weight loss at 24 weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone) | Comparison of BWL+VOUCHER and BWL+HOME vs BWL-Alone in weight loss (percent of initial weight) at 24 weeks. | Change from baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent initial weight loss at 24 weeks (BWL+HOME vs BWL+VOUCHER) | Comparison of BWL+HOME vs BWL+VOUCHER in weight loss (percent of initial weight) at 24 weeks. | Change from baseline to 24 weeks | 
| General health-related quality of life (BWL+VOUCHER and BWL+HOME vs BWL-Alone) | Change from baseline to week 24 in general health-related quality of life as assessed with the Short Form-36. Scores range from 0 (worse) to 100 (best). | Change from baseline to 24 weeks | 
| Weight-related quality of life (BWL+VOUCHER and BWL+HOME vs BWL-Alone) | Change from baseline to week 24 in weight-related quality of life as assessed with the Impact of Weight on Quality of Life-Lite. Scores range from 0 (worse) to 100 (best). | Change from baseline to 24 weeks | 
| Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone) | Change from baseline to week 24 in skin carotenoid levels | Change from baseline to 24 weeks | 
| Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone) | Change from baseline to week 24 in Healthy Eating Index scores as measured with the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. Scores range from 0 (worse) to 100 (best). | Change from baseline to 24 weeks | 
| General health-related quality of life (BWL+VOUCHER vs BWL+HOME) | Change from baseline to week 24 in general health-related quality of life as assessed with the Short Form-36. Scores range from 0 (worse) to 100 (best). | Change from baseline to 24 weeks | 
| Weight-related quality of life (BWL+VOUCHER vs BWL+HOME) | Change from baseline to week 24 in weight-related quality of life as assessed with the Impact of Weight on Quality of Life-Lite. Scores range from 0 (worse) to 100 (best). | Change from baseline to 24 weeks | 
| Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER vs BWL+HOME) | Change from baseline to week 24 in skin carotenoid levels | Change from baseline to 24 weeks | 
| Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER vs BWL+HOME) | Change from baseline to week 24 in Healthy Eating Index scores as measured with the ASA24. Scores range from 0 (worse) to 100 (best). | Change from baseline to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, food insecurity, weight loss