Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-12 @ 3:31 AM
Study NCT ID:
NCT06837805
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-01
First Post:
2025-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iowa Produce Prescription Program
Sponsor:
Iowa State University
Organization:
Study Overview
Official Title:
Iowa Produce Prescription Program: Improving the Health Status of Iowans Facing Nutrition Insecurity
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
I-PPP
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: