A Randomized Crossover Trial Evaluating the Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c from Baseline to 5 Months
研究概览
简要总结
This study is testing whether providing monthly vouchers to buy fruits and vegetables can help improve blood sugar control in adults with type 2 diabetes. People receiving care at WVU clinics who recently had an HbA1c level above 8% will be invited to participate in the study. Those who are interested will speak with a study coordinator, be screened for eligibility, and, if eligible, will provide written consent to join the study. Participants will be randomly assigned to one of two groups. One group will receive $100 per month in produce-only grocery vouchers and standardized dietary education for 5 months, followed by 5 months of usual diabetes care. The second group will receive usual diabetes care first for 5 months, followed by 5 months of produce-only grocery vouchers and standardized dietary education. This crossover design allows all participants to experience both approaches during the study. Researchers will measure changes in blood sugar (HbA1c) as the main outcome. Other outcomes include blood pressure, cholesterol levels, body weight, diet quality, food security, anxiety symptoms, depressive symptoms, and physical activity. These will be assessed through lab tests, clinic measurements, and surveys at certain time points during the 10 month study period. The study team will also track how often participants use the vouchers and any challenges they face. The risks of participating are expected to be minimal and similar to routine diabetes care. The total study duration, including enrollment, participation, and analysis, is expected to be about 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus
- •Most recent HbA1c >8% within the prior 6 months
- •Must have had a clinic visit within the past 6 months
- •Positive screening for food insecurity based on the USDA 6-item food security survey
- •Receiving care through WVU cardiometabolic, endocrinology, or primary care clinics
- •Able and willing to provide written informed consent
排除标准
- •End-stage renal disease
- •Advanced heart failure
- •Severe cognitive impairment
- •Chronic pancreatitis
- •Pancreatic malignancy
- •Pregnancy at time of enrollment
- •Anticipated inability to utilize intervention vouchers (e.g., lack of access to Walmart)
研究组 & 干预措施
Produce Gift Card to Usual Care
Participants are randomized to receive the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for 5 months, followed by crossover to usual care for an additional 5 months.
干预措施: Usual Care (Other)
Usual Care to Produce Gift Card
Participants are randomized to receive usual care for 5 months, followed by crossover to the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for an additional 5 months.
干预措施: Produce Gift Card and Dietary Education (Behavioral)
Produce Gift Card to Usual Care
Participants are randomized to receive the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for 5 months, followed by crossover to usual care for an additional 5 months.
干预措施: Produce Gift Card and Dietary Education (Behavioral)
Usual Care to Produce Gift Card
Participants are randomized to receive usual care for 5 months, followed by crossover to the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for an additional 5 months.
干预措施: Usual Care (Other)
结局指标
主要结局
Change in Hemoglobin A1c from Baseline to 5 Months
时间窗: Baseline and 5 months
Change in hemoglobin A1c (%) measured using a standard laboratory test at baseline and at the 5-month study visit. Hemoglobin A1c reflects average blood glucose over the prior 2 to 3 months. The outcome measure is the change in hemoglobin A1c from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Change in Hemoglobin A1c from Baseline to 10 Months
时间窗: Baseline and 10 months
Change in hemoglobin A1c (%) measured using a standard laboratory test at baseline and at the 10-month study visit. Hemoglobin A1c reflects average blood glucose over the prior 2 to 3 months. The outcome measure is the change in hemoglobin A1c from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period
次要结局
- Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 5 Months(Baseline and 5 months)
- Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 10 Months(Baseline and 10 months)
- Change in Sitting Systolic Blood Pressure from Baseline to 5 Months(Baseline and 5 months)
- Change in Sitting Systolic Blood Pressure from Baseline to 10 Months(Baseline and 10 months)
- Change in Body Weight from Baseline to 5 Months(Baseline and 5 months)
- Change in Body Weight from Baseline to 10 Months(Baseline and 10 months)
- Change in Depression Score (HADS-D) from Baseline to 5 Months(Baseline and 5 months)
- Change in Body Mass Index (BMI) from Baseline to 5 Months(Baseline and 5 months)
- Change in Body Mass Index (BMI) from Baseline to 10 Months(Baseline and 10 months)
- Change in Waist Circumference from Baseline to 5 Months(Baseline and 5 months)
- Change in Waist Circumference from Baseline to 10 Months(Baseline and 10 months)
- Change in PREVENT Cardiovascular Risk Score from Baseline to 5 Months(Baseline and 5 months)
- Change in PREVENT Cardiovascular Risk Score from Baseline to 10 Months(Baseline and 10 months)
- Change in Healthy Eating Index (HEI) Score from Baseline to 5 Months(Baseline and 5 months)
- Change in Healthy Eating Index (HEI) Score from Baseline to 10 Months(Baseline and 10 months)
- Daily Fruit and Vegetable Intake from Baseline to 5 Months(Baseline and 5 months)
- Daily Fruit and Vegetable Intake from Baseline to 10 Months(Baseline and 10 months)
- Change in Anxiety Score (HADS-A) from Baseline to 5 Months(Baseline and 5 months)
- Change in Anxiety Score (HADS-A) from Baseline to 10 Months(Baseline and 10 months)
- Change in Depression Score (HADS-D) from Baseline to 10 Months(Baseline and 10 months)
- Change in Physical Activity (IPAQ) from Baseline to 5 Months(Baseline and 5 months)
- Change in Physical Activity (IPAQ) from Baseline to 10 Months(Baseline and 10 months)
- Change in Total Cholesterol from Baseline to 5 Months(Baseline and 5 months)
- Change in Total Cholesterol from Baseline to 10 Months(Baseline and 10 months)
- Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 5 Months(Baseline and 5 months)
- Change in Low-Density Lipoprotein (LDL) Cholesterol Baseline to 10 months(Baseline and 10 months)
- Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 5 Months(Baseline and 5 months)
- Change in High-Density Lipoprotein (HDL) Cholesterol Baseline to 10 months(Baseline and 10 months)
- Change in Triglycerides from Baseline to 5 Months(Baseline and 5 months)
- Change in Triglycerides Baseline to 10 months(Baseline and 10 months)
研究者
George Sokos
Professor of Medicine; Medical Director, Non-Invasive Cardiology, Advanced Heart Failure, Pulmonary Hypertension, Cardiac Transplant
West Virginia University