Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity

Not Applicable

Active, not recruiting

• Conditions: Overweight and Obesity

• Registration Number: NCT06751563
• Lead Sponsor: Johns Hopkins University

Brief Summary

The goal of this study is to understand the best practices for implementing produce prescriptions among adults with overweight or obesity experiencing nutrition insecurity. Enrolled participants will receive an 8-week intervention aimed at increasing nutrition knowledge, self-efficacy for healthy eating, and barriers to healthy food access. Participants will be randomly assigned to one of two produce prescription implementation strategies:

Program 1: Participants will receive weekly produce vouchers that are redeemable at a local vendor.

Program 2. Participants will receive fresh produce delivered directly to the participant's home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce the participant prefers to receive.

Researchers will compare engagement in and adherence to the intervention and the patterns of difference in 8-week changes in fruit and vegetable consumption and weight.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-30
• Study Start: 2025-01-08
• Primary Completion: 2025-04-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Adult 18 years of age or older
• Living with overweight or obesity, defined as a BMI ≥25
• Screens positive for nutrition insecurity
• Has a smartphone with a data plan
• Willing to receive daily text messages
• Has an address that can receive delivery
• Can read and write in English
• Is willing to pick up produce at the Northeast Market

Exclusion Criteria

• Participating in another related research study
• Currently taking weight loss drugs
• Cardiovascular disease event in the last 6 months
• Active cancer
• Recent hospitalization due to psychiatric condition or event
• Pregnancy or planned during the study period
• Currently breastfeeding
• Documented dementia
• On kidney dialysis
• Planned or recent bariatric surgery
• Weight exceeding 440 lbs.
• Exclusion at principal investigators discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Reached	8 weeks	The investigators will track the number of referrals, number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.

Secondary Outcome Measures

Name	Time	Method
Nutrition insecurity as assessed by the 4-item Nutrition Security Screening Questionnaire	Baseline, 4 weeks, 8 weeks	Nutrition insecurity will be assessed using Center for Nutrition Health and Impact questionnaire with a 4-item scale that has a score range of 0-16. The higher the score, the greater the level of food security and control an individual has over their nutrition.
Change in Fruit and Vegetable Consumption as assessed by the 9-item Mini-Eating Assessment Tool (EAT)	Baseline, 4 weeks, and 8 weeks	Consumption of food groups will be assessed using the 9-item Mini-Eating Assessment Tool (EAT) questionnaire. Each food group is assessed using a 9-point Likert scale ranging from I do not eat it at all to 6 or more servings per day. The survey is scored from 0-90 where a higher score indicates a healthier diet and a better outcome.
Weight (kg)	Baseline, 8 weeks	Weight will be taken by study staff and measured to the nearest 0.1 kg.

Trial Locations

Locations (1)

Northeast Market; 🇺🇸 Baltimore, Maryland, United States