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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProduceRx | Experimental | Participants in the ProduceRx intervention group will be provided with BWL and produce vouchers for fresh fruits and vegetables. |
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| Waitlist Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral weight loss and produce vouchers | Behavioral | 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. |
| 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 |
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ariana M Chao, PhD, CRNP | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |