Iowa Produce Prescription Program

NCT06837805 | Enrolling By Invitation

• 1 other identifier: 22-314
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Diabetes Mellitus Type 2; Pre-diabetes

Keywords

produce prescription; behavioral nutrition intervention; online nutrition education; self determination theory

Outcome Measures

Primary Outcomes (1)

• Nutrition Security

  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.

  From Month 1 of the intervention to the end of the intervention (Month 6)

Secondary Outcomes (3)

• Hemoglobin A1c (HA1c)

  From Month 1 of the intervention to the end of the intervention (Month 6)

• Dietary Intake

  From Month 1 of the intervention to the end of the intervention (Month 6)

• Psychosocial Mediators

  From Month 1 of the intervention to the end of the intervention (Month 6)

Other Outcomes (4)

• Body Mass Index (BMI)

  From Month 1 of the intervention to the end of the intervention (Month 6)

• Food Security

  From Month 1 of the intervention to the end of the intervention (Month 6)

• Lipid Panel

  From Month 1 of the intervention to the end of the intervention (Month 6)

Study Arms (3)

I-PPP+PYP Group

EXPERIMENTAL

The I-PPP+PYP participants will participate in both the Iowa Produce Prescription Program and the Produce Your Path Behavioral Nutrition Intervention. This group will complete the monthly PYP intervention modules to receive the produce prescription dollar amount, which can be redeemed at partnering retail locations on fresh fruits and vegetables. An optional Facebook group for the I-PPP+PYP participants with offer additional social support and resources for participants, who can use the Facebook page to post questions, share goals and recipes, and answer prompts posted by the research team.

Other: Iowa Produce Prescription Program (I-PPP); Behavioral: Produce Your Path Behavioral Nutrition Intervention (PYP)

PYP Alone Group

EXPERIMENTAL

The PYP Alone Group will complete the six-month behavioral nutrition intervention, but will not receive monthly incentives to redeem for fresh fruits and vegetables. PYP Alone participants will still complete the corresponding quizzes to monthly education modules. The PYP Alone participants will also have access to separate optional Facebook group to post questions, share goals and recipes, and answer prompts posted by the research team.

Behavioral: Produce Your Path Behavioral Nutrition Intervention (PYP)

Control Group

NO INTERVENTION

This group will not receive the produce prescription incentive or behavioral intervention.

Interventions

Iowa Produce Prescription Program (I-PPP) OTHER

The I-PPP intervention offers a produce prescription in the form of $30.00 per family member in a household every month to spend on fruit and vegetables. The dollars can be used at local retail partners, which are specific to each community. A mobile app has been developed for the I-PPP intervention participants. At the beginning of each month for six months, the app asks participants to complete a nutrition education module and a corresponding short quiz. After the participant completes the module, $30.00 per family member in the house will be loaded into the app for participants to use over the next month at local retail partners to buy fresh fruits and vegetables. Participants will have 30 days from the date of distribution to spend the funds before they expire.

I-PPP+PYP Group

Produce Your Path Behavioral Nutrition Intervention (PYP) BEHAVIORAL

The PYP Intervention is a six-month virtual behavioral intervention grounded in Self Determination Theory. The intervention aims to improve participants' competence, autonomy, and sense of relatedness through educational videos, recipes, and supplemental resources. Each monthly module contains several short videos, totaling around 15 minutes in length. The module topics include goal-setting, planning meals, preparing fruits and vegetables, reading nutrition labels, budgeting for healthier eating, and making healthier food swaps. The videos are tailored to represent a variety of cultures, ethnicities, and backgrounds, with diverse actors and recipes. Upon completion of each monthly module, a short quiz is administered to participants to measure self-efficacy related to the topic and prompt goal-setting. To further increase social support, an optional Facebook Group component allows participants to post questions, share goals and recipes, and answer prompts from the research team.

I-PPP+PYP Group; PYP Alone Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50014, United States

Location

Related Links

• Iowa Healthiest State Initiative's Iowa Produce Rx webpage.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 20, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

US (1)