Iowa Produce Prescription Program (I-PPP)

Iowa State University

Status: Invitation-only

Conditions: Pre-diabetes; Diabetes Mellitus Type 2

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06837805

22-314

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

I-PPP+PYP Group

Experimental group

Description:

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.

Treatment:

Other: Iowa Produce Prescription Program (I-PPP)

Behavioral: Produce Your Path Behavioral Nutrition Intervention (PYP)

PYP Alone Group

Experimental group

Description:

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.

Treatment:

Behavioral: Produce Your Path Behavioral Nutrition Intervention (PYP)

Control Group

No Intervention group

Description:

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