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Enrolling by invitation NCT06837805

Iowa Produce Prescription Program

No phase Interventional Diabetes Mellitus Type 2 Pre-diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iowa Produce Prescription Program (I-PPP), Produce Your Path Behavioral Nutrition Intervention (PYP).
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type 2, Pre-diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Iowa Produce Prescription Program: Improving the Health Status of Iowans Facing Nutrition Insecurity

Overview

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

Interventions

  • Other 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 mod
  • Behavioral 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

Primary outcome measures

  • Nutrition Security [Time frame: From Month 1 of the intervention to the end of the intervention (Month 6)]
Secondary outcome measures (3)
  • Hemoglobin A1c (HA1c) [Time frame: From Month 1 of the intervention to the end of the intervention (Month 6)]
  • Dietary Intake [Time frame: From Month 1 of the intervention to the end of the intervention (Month 6)]
  • Psychosocial Mediators [Time frame: From Month 1 of the intervention to the end of the intervention (Month 6)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Iowa State University — Ames

Identifiers

NCT: NCT06837805 · 22-314

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗