Clinical trial NCT06837805: Iowa Produce Prescription Program
Official title: Iowa Produce Prescription Program: Improving the Health Status of Iowans Facing Nutrition Insecurity
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus Type 2
Pre-diabetes
Keywords: produce prescription
behavioral nutrition intervention
online nutrition education
self determination theory
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Nutrition Security
timeFrame: From Month 1 of the intervention to the end of the intervention (Month 6)
Secondary outcomes:
measure: Hemoglobin A1c (HA1c)
timeFrame: From Month 1 of the intervention to the end of the intervention (Month 6)
measure: Dietary Intake
timeFrame: From Month 1 of the intervention to the end of the intervention (Month 6)
measure: Psychosocial Mediators
timeFrame: From Month 1 of the intervention to the end of the intervention (Month 6)
Other outcomes:
measure: Body Mass Index (BMI)
timeFrame: From Month 1 of the intervention to the end of the intervention (Month 6)
measure: Food Security
timeFrame: From Month 1 of the intervention to the end of the intervention (Month 6)
measure: Lipid Panel
timeFrame: From Month 1 of the intervention to the end of the intervention (Month 6)
measure: Blood Pressure
timeFrame: From Month 1 of the intervention to the end of the intervention (Month 6)
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
References: