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临床试验/NCT06837805
NCT06837805Enrolling By Invitation不适用

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

Iowa State University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
2
主要终点
Nutrition Security

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Nutrition Security

时间窗: From Month 1 of the intervention to the end of the intervention (Month 6)

The USDA's definition of Nutrition Security is 'all Americans have consistent and equitable access to healthy, safe, affordable foods essential to optimal health and well-being'. To measure participant's nutrition security, the investigators will administer the four-item Household Nutrition Security tool developed by the Center for Nutrition \& Health Impact. Participants of every arm of the study will complete the nutrition security items as part of the Baseline Survey (Month 1) and Post-Survey (Month 6). Participants will answer the four questions using a 5-point Likert frequency scale (never to always). The answers correspond to a number, and the overall score is the mean of the four answers, with lower scores indicating less nutrition security.

次要结局

  • Hemoglobin A1c (HA1c)(From Month 1 of the intervention to the end of the intervention (Month 6))
  • Dietary Intake(From Month 1 of the intervention to the end of the intervention (Month 6))
  • Psychosocial Mediators(From Month 1 of the intervention to the end of the intervention (Month 6))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lyndi Buckingham-Schutt

Assistant Professor

Iowa State University

研究点 (2)

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