A Two-Arm Randomized Controlled Trial to Evaluate the Impact of a Food Is Medicine Program on Diabetes-Related Health Outcomes in People With Type 2 Diabetes in a Low Income Community-Based Setting Compared to Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
The goal of this clinical trial is to learn if a food is medicine intervention (Healthy Food Rx) improves diabetes-related outcomes in adults diagnosed with type 2 diabetes in a low-income, community-based setting more than usual care. The main questions the study aims to answer are:
- Does Healthy Food Rx program participation lead to improved A1C values (a measure of glycemic control over approximately the past three months) over a 6-month period compared to usual care in a highly food insecure population?
- Does the Healthy Food Rx program lead to improved diabetes-related behaviors over a 6-month period compared to usual care in a highly food insecure population? Researchers will compare the Healthy Food Rx program to usual care to see if diabetes-related outcomes, including A1C, fruit and vegetable consumption, food security, physical activity, diabetes self-management behaviors and general physical and mental health status, improved more in those receiving Healthy Food Rx. Healthy Food Rx is a program that provides home-delivered, family-sized, recipe-based healthy food boxes with an approximate value of $40 every other week for 6 months to people with Type 2 diabetes living in Stockton, CA. Produce is sourced from local Central Valley growers, and the boxes also include pantry staples like chicken, fish, egg, beans and healthy snacks, such as nuts, yogurt, and cheese. Nutrition education opportunities are also provided to participants.
Participants will:
- Complete surveys at two time points in either English or Spanish. The surveys last around 10 minutes and will be conducted by trained Health Educators.
- Provide HIPAA consent to allow researchers to obtain A1C values and demographic information from their medical record.
- Retest A1C around the conclusion of the study.
Intervention participants will receive Healthy Food Rx immediately following enrollment and the control group will receive Healthy Food Rx at the end of the study.
详细描述
Background and purpose The Healthy Food Rx project's goal is to improve diabetes related outcomes by increasing access to fresh, seasonal fruits and vegetables and other healthy foods in low-income communities disproportionately affected by diabetes with the "Healthy Food Prescription (Rx) Program". The project will provide recipe-based healthy food boxes through community partnerships enabling home delivery and complementary nutrition education opportunities (virtual and in-person). The Healthy Food Rx program aims to improve hemoglobin A1C, food security, dietary quality, and diabetes self-management behaviors in patients with Type 2 diabetes at a Federally Qualified Health Clinic (FQHC) in Stockton, CA more than usual care.
Methods Intervention Through partnerships with community organizations, Healthy Food Rx provides family-sized, recipe-based healthy food boxes with an approximate value of $40 every other week for 6 months. The boxes are home-delivered and complementary nutrition education opportunities are provided to participants. Produce is sourced from local Central Valley growers, and the boxes also include pantry staples like chicken, fish, egg, beans and healthy snacks, such as nuts, yogurt, and cheese.
Design This study builds on the findings of two previous pre-post studies without a comparison group showing significantly improved diabetes-related outcomes in program participants. To evaluate whether the Healthy Food Rx program improves these outcomes significantly more than usual care this study will be a randomized controlled trial with delayed intervention for the control group. To maintain ethical practices, control participants who have been asked to contribute their time and data to this study will receive the program at the conclusion of the follow-up surveys.
Enrolled participants will complete two 10-minute interviewer administered surveys either in person or by phone; the baseline survey will be conducted during enrollment and for the intervention group, the follow-up survey will be conducted after completion of the 6-month intervention; for the control group, follow-up surveys will be conducted about 6 months after the baseline survey. Surveys will be conducted by trained Health Educators in the participant's preferred language of English or Spanish. The responses will be recorded in an online, secure data platform.
The intervention group will start receiving Healthy Food Rx after completing the baseline survey. A1C and demographic data will be collected from medical records with HIPAA-compliant patient consent. All other outcomes will be included in the surveys using validated questions, where appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Adult (over age 18)
- •Diagnosed with Type 2 diabetes
- •Residing in Stockton, CA
- •Recent (within previous 3 months) A1C above 7%
- •Patient of study site clinic
排除标准
- •previous program participant
- •no home address to receive the food boxes
- •unable to receive text messages
研究组 & 干预措施
Intervention group
This group will receive Healthy Food Rx after enrollment.
干预措施: Food is medicine (Dietary Supplement)
Control group
This group will not receive Healthy Food Rx during the study, however they will receive Healthy Food Rx after the study conclusion.
结局指标
主要结局
Hemoglobin A1C
时间窗: They will be measured at 2 points in time. Baseline value is valid up to 3 months before enrollment Follow-up, A1C measures are valid from 60 days before to 90 days after the last food box delivery.
A1C is a measure of glycemic control over approximately the past three months. Measures will be extracted from patient's medical records with HIPAA consent.
次要结局
- Food insecurity(Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.)
- Fruit consumption(Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.)
- Vegetable consumption(Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.)
- Water consumption(Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.)
- Physical activity(Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.)
- Self-reported physical health status(Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.)
- Self-reported mental health status(Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.)
- Diabetes self-management(Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.)
研究者
Margaret Wilkin
Director of Research and Evaluation
Public Health Institute Center for Wellness and Nutrition