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

NCT05362747 | Completed

• 1 other identifier: 851009
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Keywords

food insecurity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Percent initial weight loss

  Baseline, 12 weeks

• Systolic blood pressure

  Baseline, 12 weeks

• Diastolic blood pressure

  Baseline, 12 weeks

• Waist circumference

  Baseline, 12 weeks

• Pulse

  Baseline, 12 weeks

Study Arms (2)

ProduceRx

EXPERIMENTAL

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

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.

Interventions

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.

ProduceRx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ariana M Chao, PhD, CRNP

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 5, 2022
• Study Start: April 26, 2022
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)