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

November 3, 2025 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Northeast Market

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Produce Voucher
Behavioral Text Message Program + Produce Voucher
Behavioral: Behavioral Text Message Program and Produce Voucher
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.
Experimental: Produce Boxes
Behavioral Text Message Program + Produce Box Delivery
Behavioral: Behavioral Text Messages and Produce Box Delivery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reached
Time Frame: 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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition insecurity as assessed by the 4-item Nutrition Security Screening Questionnaire
Time Frame: 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.
Baseline, 4 weeks, 8 weeks
Change in Fruit and Vegetable Consumption as assessed by the 9-item Mini-Eating Assessment Tool (EAT)
Time Frame: 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.
Baseline, 4 weeks, and 8 weeks
Weight (kg)
Time Frame: Baseline, 8 weeks
Weight will be taken by study staff and measured to the nearest 0.1 kg.
Baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Maryland Department of Health and Mental Hygiene
Maryland Cigarette Restitution Fund

Investigators

  • Principal Investigator: Hailey Miller Assistant Professor, RN, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Actual)

April 4, 2025

Study Completion (Actual)

June 6, 2025

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 30, 2024

Study Record Updates

Last Update Posted (Estimated)

November 4, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00463007

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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