Iowa Produce Prescription Program

NCT ID: NCT06837805

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-05-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus Type 2 Pre-diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I-PPP+PYP Group

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.

Group Type EXPERIMENTAL

Iowa Produce Prescription Program (I-PPP)

Intervention Type 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.

Produce Your Path Behavioral Nutrition Intervention (PYP)

Intervention Type 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.

PYP Alone Group

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.

Group Type EXPERIMENTAL

Produce Your Path Behavioral Nutrition Intervention (PYP)

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Iowa Produce Prescription Program (I-PPP)

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.

Intervention Type OTHER

Produce Your Path Behavioral Nutrition Intervention (PYP)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iowa State University

OTHER

Sponsor Role lead

Responsible Party

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Lyndi Buckingham-Schutt

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Iowa State University

Ames, Iowa, United States

Site Status

Countries

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United States

Related Links

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https://www.iowahealthieststate.com/produce-rx

Iowa Healthiest State Initiative's Iowa Produce Rx webpage.

Other Identifiers

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22-314

Identifier Type: -

Identifier Source: org_study_id

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