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Completed

NCT Number: NCT06751563

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeast Market

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants Reached

    Time frame: From screening up to 8 weeks

    The investigators will track the number of number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.

Secondary outcomes

  1. Nutrition Insecurity as Assessed by the 4-item Nutrition Security Screening Questionnaire

    Time frame: Baseline to 8 weeks

    Nutrition insecurity will be assessed using Center for Nutrition Health and Impact questionnaire with a 4-item scale. The higher the score, the greater the level of food security and control an individual has over their nutrition. The four items within the measure are scored from 0 to 4. Then, the measure's score is simply the mean of the responses.

  2. 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. Evaluates consumption of key food groups. Fruit and vegetable consumption were each based on two questions within the MINI eat scale, not subscales. Fruit ranges from 1 to 7 where 1 = less than 1 serving per week, and 7 = 4 or more servings per day. Vegetables range from 1 to 6 where 1 = less than 3 servings per week, and 6 = 4 or more servings per day. Mini-EAT score range 0-90. Higher scores better consumption.

  3. Weight (kg)

    Time frame: Baseline, 8 weeks

    Weight will be taken by study staff and measured to the nearest 0.1 kg.

  4. Blood Pressure (mmHg)

    Time frame: Baseline, 8 Weeks

    Blood pressure was measured using the Omron 10 Series ® Upper Arm Blood Pressure Monitor. Participants were instructed to rest for five minutes before two blood pressure readings were taken on the upper arm, one minute apart. Measurements were averaged for analysis.

  5. Health Self-Efficacy as Assessed by the 11-item Healthy Eating and Weight Self-Efficacy Scale

    Time frame: Baseline, 8 weeks

    Self-efficacy was measured using the 11-item Healthy Eating and Weight Self-Efficacy Scale. Responses were rated on a Likert scale that ranged from "Strongly Disagree" to "Strongly Agree". Responses were summed to create a total score ranging from 11 to 55, with higher scores representing greater self-efficacy.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Maryland Cigarette Restitution Fund
  • Maryland Department of Health and Mental Hygiene

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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