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

NCT ID: NCT05362747

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2023-06-02

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ProduceRx

Participants in the ProduceRx intervention group will be provided with BWL and produce vouchers for fresh fruits and vegetables.

Group Type: EXPERIMENTAL

Behavioral weight loss and produce vouchers

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariana M Chao, PhD, CRNP

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

851009

Identifier Type: -

Identifier Source: org_study_id