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

NCT ID: NCT06751563

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2025-06-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Produce Voucher

Behavioral Text Message Program + Produce Voucher

Group Type: EXPERIMENTAL

Behavioral Text Message Program and Produce Voucher

Intervention Type: 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 Boxes

Behavioral Text Message Program + Produce Box Delivery

Group Type: EXPERIMENTAL

Behavioral Text Messages and Produce Box Delivery

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maryland Department of Health and Mental Hygiene

OTHER_GOV

Sponsor Role: collaborator

Maryland Cigarette Restitution Fund

OTHER_GOV

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hailey Miller Assistant Professor, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Northeast Market

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00463007

Identifier Type: -

Identifier Source: org_study_id