Clinical trial NCT06751563: Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity
Official title: A Randomized Pilot Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: obesity
overweight
produce prescription
produce voucher
nutrition
nutrition security
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Maryland Department of Health and Mental Hygiene
name: Maryland Cigarette Restitution Fund
First posted: 2024-12-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Participants Reached
timeFrame: 8 weeks
Secondary outcomes:
measure: Nutrition insecurity as assessed by the 4-item Nutrition Security Screening Questionnaire
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Fruit and Vegetable Consumption as assessed by the 9-item Mini-Eating Assessment Tool (EAT)
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Weight (kg)
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Northeast Market
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hailey Miller Assistant Professor, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: