ProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity

Study Overview
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Brief Summary
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This is a pilot randomized controlled trial to assess the effects of providing produce vouchers during behavioral weight loss treatment in 40 adults with obesity and food insecurity. Participants will be randomized to ProduceRx (12 weekly sessions of in-person, behavioral weight loss counseling (BWL) + produce prescriptions) or a waitlist control (WLC).

Detailed Description
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The proposed investigation is a single-site, pilot RCT to assess the effect of BWL and produce vouchers (ProduceRx) on diet quality, weight loss and cardiovascular risk factors among adult participants with food insecurity and obesity. Adults (N=40) will be randomized to a 12-week program that provides weekly, 30-minute BWL sessions + produce vouchers (n=20) or WLC (n=20). Outcomes will be assessed at baseline and at 12 weeks and include questionnaires, and measurements of weight, height, and cardiometabolic risk factors (blood pressure, waist circumference, and pulse). Participants will also be asked to complete two 24-hour dietary recalls.

Official Title
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ProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Behavioral weight loss and produce vouchers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old BMI ≥ 30 kg/m2 Food insecurity as assessed by the two-item hunger vital sign Subjects must: have reliable telephone or Internet service to communicate with study staff plan to remain in the Philadelphia area for the next 6 months or more Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent. Exclusion Criteria: Pregnant, nursing, or plans to become pregnant in the next 6 months Serious medical risk such as uncontrolled diabetes, cancer, congestive heart failure, or recent cardiac event (e.g., myocardial infarction or stroke within the past 6 months) Clinically significant hepatic or renal disease History of (or plans for) bariatric surgery Current psychiatric disorder that significantly interferes with daily living Self-reported alcohol or substance abuse within the past 12 months Use in past 3 months of medications known to induce significant weight loss (i.e., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics) Loss of ≥ 10 lb of body weight within the past 3 months Participation in a structured weight loss program in the prior 6 months Inability to walk 2 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming) Participant from same household Inability to attend treatment and/or assessment visits Lack of capacity to provide informed consent Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProduceRx<br>Participants in the ProduceRx intervention group will be provided with BWL and produce vouchers for fresh fruits and vegetables. | Behavioral: Behavioral weight loss and produce vouchers<br>* Participants will receive weekly 30-minute, individual, in-person lifestyle counseling delivered by trained interventionists (e.g., registered dietitians) that consists of behavioral, dietary, and physical activity counseling. ProduceRx vouchers will be in the form of Food Bucks and will be provided at each session.<br>|
| No Intervention: Waitlist Control<br>Participants in the WLC group with be asked to stay weight stable, not to make changes in their eating and physical activity behaviors, and not to seek treatment for weight or eating during the waiting period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary quality | Change from baseline to 12 weeks in dietary quality from 24-hour dietary recalls summarized into Healthy Eating Index (HEI) Scores and caloric intake. Scores range from 0 to 100 with higher scores indicating better diet quality. | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent initial weight loss | Change from baseline to 12 weeks in percent initial weight loss | Baseline, 12 weeks | 
| Systolic blood pressure | Change from baseline to 12 weeks in systolic blood pressure | Baseline, 12 weeks | 
| Diastolic blood pressure | Change from baseline to 12 weeks in diastolic blood pressure | Baseline, 12 weeks | 
| Waist circumference | Change from baseline to 12 weeks in waist circumference | Baseline, 12 weeks | 
| Pulse | Change from baseline to 12 weeks in pulse rate | Baseline, 12 weeks | 
| Health-related quality of life | Change from baseline to 12 weeks in general health-related quality of life (Short-Form-36). Scores range from 0 to 100 with higher scores indicating better quality of life. | Baseline, 12 weeks | 
| Weight-related quality of life | Change from baseline to 12 weeks in weight-related QOL (Impact of Weight on Quality of Life-Lite). Scores range from 0 to 100 with higher scores indicating better quality of life. | Baseline, 12 weeks | 
| Food security | Change from baseline to 12 weeks in the USDA Food Security Survey. Scores range from 0-10 with higher scores indicating lower food security. | Baseline, 12 weeks | 
| Depressive symptoms | Change from baseline to 12 weeks in Patient Health Questionnaire-8 Scores. Scores range from 0 to 24 with higher scores indicating more depressive symptoms. | Baseline, 12 weeks | 
| Food addiction | Change from baseline to 12 weeks in Yale Food Addiction Scores. Symptom scores range from 0 to 11 with higher scores indicating more symptoms. | Baseline, 12 weeks | 
| Eating behaviors | Change from baseline to 12 weeks in Eating Behaviors. Higher scores indicate greater agreement. | Baseline, 12 weeks | 
| Self-regulation of eating | Change from baseline to 12 weeks in self-regulation of eating as measured by the Regulation of Eating Behavior Scale. Scores range from 24 to 168 with higher scores indicating more self-regulation. | Baseline, 12 weeks | 
| Self-regulation of exercise | Change from baseline to 12 weeks in Behavioral Regulation in Exercise Questionnaire. Scores range from 0 to 76 with higher scores indicating more self-regulation. | Baseline, 12 weeks | 
| Self-efficacy | Change from baseline to 12 weeks in scores on the Weight Efficacy Lifestyle Questionnaire. Total scores range from 0 to 180. Higher scores represent greater eating self-efficacy. | Baseline, 12 weeks | 
| Physical activity | Change from baseline to 12 weeks in scores on the International Physical Activity Questionnaire. Higher scores indicate more physical activity. | Baseline, 12 weeks | 
| Perceived Stress Scale | Change from baseline to 12 weeks in scores on the Perceived Stress Scale. Scores range from 0-56 with higher scores indicating more stress. | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food insecurity