Iowa Produce Prescription Program

Not Applicable

• Conditions: Diabetes Mellitus Type 2; Pre-diabetes

• Registration Number: NCT06837805
• Lead Sponsor: Iowa State University

Brief Summary

The goal of this study is to understand how a Produce Prescription Program paired with a behavioral nutrition intervention affect nutrition and overall health in low-income Iowans with type 2 diabetes or pre-diabetes. Research questions include:

1. What impact does a produce prescription program paired with a behavioral nutrition intervention on nutrition security compared to the behavioral nutrition intervention alone and usual care groups?

2. What impact does a produce prescription program paired with a behavioral nutrition intervention on hemoglobin A1c, fruit and vegetables intake, food security, and related behaviors compared to the behavioral nutrition intervention alone and usual care groups?

Participants of the behavioral nutrition intervention (Produce Your Path) alone will:

* Watch monthly nutrition education videos about topics like planning and budgeting for groceries, reading nutrition labels, eating more fruits and vegetables, and new recipes to try

* Complete a short quiz about their own goals and habits related to the topic

* (Optional): Join a Facebook group to communicate with other participants about their goals, share ideas and recipes, and ask questions

Participants of both the Produce Prescription and Produce Your Path Interventions will:

* Complete each monthly nutrition education module and monthly quiz

* (Optional): Join a Facebook group to communicate with other participants about their goals, share ideas and recipes, and ask questions

* Receive $30.00 per each person in their household monthly to buy fresh fruits and vegetables

Participants of the control group will:

* Follow their usual care for health conditions

* Complete the required data collection for the study

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-01
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-01
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age 18 and older
• Pre-diabetic or diabetic diagnosis by medical provider;
• Receiving medical assistance under a state plan (Medicaid) or eligible for Supplemental Nutrition Assistance Program (SNAP) benefits;
• Owns a smart phone;
• Able to read and understand English; speaks English;
• Patient at a partnering health care clinic;
• No one else in the household is enrolled in I-PPP

Exclusion Criteria

• Under 18 years old;
• Not pre-diabetic or diabetic (as diagnosed by medical provider);
• Does not receive medical assistance under a state plan (Medicaid) or is not eligible for SNAP benefits;
• Does not own a smart phone;
• Cannot read or understand English;
• Does not speak English;
• Is not a patient at a partnering health care clinic;
• Others in household participating in I-PPP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Nutrition Security	From Month 1 of the intervention to the end of the intervention (Month 6)	The USDA's definition of Nutrition Security is 'all Americans have consistent and equitable access to healthy, safe, affordable foods essential to optimal health and well-being'. To measure participant's nutrition security, the investigators will administer the four-item Household Nutrition Security tool developed by the Center for Nutrition \& Health Impact. Participants of every arm of the study will complete the nutrition security items as part of the Baseline Survey (Month 1) and Post-Survey (Month 6). Participants will answer the four questions using a 5-point Likert frequency scale (never to always). The answers correspond to a number, and the overall score is the mean of the four answers, with lower scores indicating less nutrition security.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HA1c)	From Month 1 of the intervention to the end of the intervention (Month 6)	Participant's hemoglobin A1c levels (HA1c) will be measured to help identify how well blood sugar levels are being managed. The Hemoglobin A1c test measures what percentage of blood hemoglobin proteins are glycated, with higher percentages indicating poorer glucose control and prediabetes or diabetes. This test is conducted by participant's primary care providers and data is released to the research team. HA1c will be collected from lab draws in electronic medical records.
Dietary Intake	From Month 1 of the intervention to the end of the intervention (Month 6)	Investigators will measure participant's fruit and vegetable consumption using the 10-item dietary assessment tool from the Center for Nutrition, which was previously adapted from the Dietary Screener Questionnaire from developed by NIH and the National Cancer Insititute. The assessment tool asks participants how often they consumed certain fruits, vegetables, and food products over the last 30 days. This dietary assessment tool is part of the Baseline Survey (Month 1) and Post-Survey (Month 6).
Psychosocial Mediators	From Month 1 of the intervention to the end of the intervention (Month 6)	Psychosocial constructs including self-efficacy, social support, and motivation level are measured in the Baseline Survey (Month 1) and Post-Survey (Month 6). Self-efficacy and social support are measured using a two- and three-item tool recommended by the Center for Nutrition, respectively. Motivational level is measured using the 15-item Treatment Self-Regulation Questionnaire, which was specifically developed to measure how intrinsically motivated a person is, as proposed by Self Determination Theory. These psychosocial constructs were chosen because the intervention is designed to increase self-efficacy and social support, and is also grounded in Self Determination Theory, aiming to increase intrinsic motivation.

Trial Locations

Locations (1)

Iowa State University; 🇺🇸 Ames, Iowa, United States