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

NCT06751563 | Completed

• 1 other identifier: IRB00463007
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

obesity; overweight; produce prescription; produce voucher; nutrition; nutrition security

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reached

  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.

  8 weeks

Secondary Outcomes (3)

• Nutrition insecurity as assessed by the 4-item Nutrition Security Screening Questionnaire

  Baseline, 4 weeks, 8 weeks

• Change in Fruit and Vegetable Consumption as assessed by the 9-item Mini-Eating Assessment Tool (EAT)

  Baseline, 4 weeks, and 8 weeks

• Weight (kg)

  Baseline, 8 weeks

Study Arms (2)

Produce Voucher

EXPERIMENTAL

Behavioral Text Message Program + Produce Voucher

Behavioral: Behavioral Text Message Program and Produce Voucher

Produce Boxes

EXPERIMENTAL

Behavioral Text Message Program + Produce Box Delivery

Behavioral: Behavioral Text Messages and Produce Box Delivery

Interventions

Behavioral Text Messages and Produce Box Delivery BEHAVIORAL

Participants will receive a produce box delivered weekly to the participants home customized based on the participants cooking preferences and household size. Participants will also receive a daily text message aimed to support a healthy diet and lifestyle. These texts will include information to build participants' knowledge and skills for healthy eating. The participants will also include weekly goals that focus on eating a healthy diet. Participants will receive automated, personalized feedback via text messages based on participant goal attainment and daily responses.

Produce Boxes

Behavioral Text Message Program and Produce Voucher BEHAVIORAL

Participants will receive a weekly produce voucher redeemable at a local market vendor for fresh produce of the participant's choice. Participants will also receive a daily text message aimed to support a healthy diet and lifestyle. These texts will include information to build participants' knowledge and skills for healthy eating. The participants will also include weekly goals that focus on eating a healthy diet. Participants will receive automated, personalized feedback via text messages based on goal attainment and daily responses.

Produce Voucher

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Maryland Department of Health and Mental Hygiene: collaborator
• Maryland Cigarette Restitution Fund: collaborator

Study Sites (1)

Northeast Market

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Hailey Miller Assistant Professor, RN, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: January 8, 2025
• Primary Completion: April 4, 2025
• Study Completion: June 6, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)