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

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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Behavioral weight loss and produce vouchers

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Coordinator; Phone Number: 215-573-7403; Email: Alex.Paul@Pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ProduceRx; 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; 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.
No Intervention: Waitlist Control; 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?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Ariana M Chao, PhD, CRNP, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): June 2, 2023
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: food insecurity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 851009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No