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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Behavioral weight loss and produce vouchers

• Registration Number: NCT05362747
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-04-26
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-05
• Primary Completion: 2023-06-02
• Study Completion: 2023-06-02
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Age ≥ 18 years old

2. BMI ≥ 30 kg/m2

3. Food insecurity as assessed by the two-item "hunger vital sign"

4. Subjects must:

   1. have reliable telephone or Internet service to communicate with study staff
   2. plan to remain in the Philadelphia area for the next 6 months or more

5. 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

1. Pregnant, nursing, or plans to become pregnant in the next 6 months
2. 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)
3. Clinically significant hepatic or renal disease
4. History of (or plans for) bariatric surgery
5. Current psychiatric disorder that significantly interferes with daily living
6. Self-reported alcohol or substance abuse within the past 12 months
7. 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)
8. Loss of ≥ 10 lb of body weight within the past 3 months
9. Participation in a structured weight loss program in the prior 6 months
10. Inability to walk 2 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)
11. Participant from same household
12. Inability to attend treatment and/or assessment visits
13. Lack of capacity to provide informed consent
14. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProduceRx	Behavioral weight loss and produce vouchers	Participants in the ProduceRx intervention group will be provided with BWL and produce vouchers for fresh fruits and vegetables.

Primary Outcome Measures

Name	Time	Method
Dietary quality	Baseline, 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Pulse	Baseline, 12 weeks	Change from baseline to 12 weeks in pulse rate
Percent initial weight loss	Baseline, 12 weeks	Change from baseline to 12 weeks in percent initial weight loss
Systolic blood pressure	Baseline, 12 weeks	Change from baseline to 12 weeks in systolic blood pressure
Perceived Stress Scale	Baseline, 12 weeks	Change from baseline to 12 weeks in scores on the Perceived Stress Scale. Scores range from 0-56 with higher scores indicating more stress.
Diastolic blood pressure	Baseline, 12 weeks	Change from baseline to 12 weeks in diastolic blood pressure
Food security	Baseline, 12 weeks	Change from baseline to 12 weeks in the USDA Food Security Survey. Scores range from 0-10 with higher scores indicating lower food security.
Waist circumference	Baseline, 12 weeks	Change from baseline to 12 weeks in waist circumference
Health-related quality of life	Baseline, 12 weeks	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.
Depressive symptoms	Baseline, 12 weeks	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.
Eating behaviors	Baseline, 12 weeks	Change from baseline to 12 weeks in Eating Behaviors. Higher scores indicate greater agreement.
Self-regulation of eating	Baseline, 12 weeks	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.
Physical activity	Baseline, 12 weeks	Change from baseline to 12 weeks in scores on the International Physical Activity Questionnaire. Higher scores indicate more physical activity.
Weight-related quality of life	Baseline, 12 weeks	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.
Food addiction	Baseline, 12 weeks	Change from baseline to 12 weeks in Yale Food Addiction Scores. Symptom scores range from 0 to 11 with higher scores indicating more symptoms.
Self-regulation of exercise	Baseline, 12 weeks	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.
Self-efficacy	Baseline, 12 weeks	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States