Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity

Официальное название

A Randomized Crossover Trial Evaluating the Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity

Обзор

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.

Вмешательства

• Поведенческое Produce Gift Card and Dietary Education
  Participants receive $100 per month in Walmart gift cards restricted to the purchase of fruits and vegetables. Gift cards are provided monthly during the intervention period and usage is tracked using participant-specific access codes. Participants also receive standardized dietary education consistent with current clinical guidelines, delivered by study personnel during the intervention period only.
• Другое Usual Care
  Participants receive standard clinical care for management of type 2 diabetes. No study-provided produce vouchers or study-provided dietary education are provided during this period.

Первичные конечные точки

• Change in Hemoglobin A1c from Baseline to 5 Months [Срок оценки: Baseline and 5 months]
• Change in Hemoglobin A1c from Baseline to 10 Months [Срок оценки: Baseline and 10 months]

Вторичные конечные точки (12)

• Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 5 Months [Срок оценки: Baseline and 5 months]
• Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 10 Months [Срок оценки: Baseline and 10 months]
• Change in Sitting Systolic Blood Pressure from Baseline to 5 Months [Срок оценки: Baseline and 5 months]
• Change in Sitting Systolic Blood Pressure from Baseline to 10 Months [Срок оценки: Baseline and 10 months]
• Change in Body Weight from Baseline to 5 Months [Срок оценки: Baseline and 5 months]
• Change in Body Weight from Baseline to 10 Months [Срок оценки: Baseline and 10 months]
• Change in Body Mass Index (BMI) from Baseline to 5 Months [Срок оценки: Baseline and 5 months]
• Change in Body Mass Index (BMI) from Baseline to 10 Months [Срок оценки: Baseline and 10 months]
• Change in Waist Circumference from Baseline to 5 Months [Срок оценки: Baseline and 5 months]
• Change in Waist Circumference from Baseline to 10 Months [Срок оценки: Baseline and 10 months]
• Change in PREVENT Cardiovascular Risk Score from Baseline to 5 Months [Срок оценки: Baseline and 5 months]
• Change in PREVENT Cardiovascular Risk Score from Baseline to 10 Months [Срок оценки: Baseline and 10 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• West Virginia University Heart and Vascular Institute — Morgantown

Публикации

• Panizza CE, Shvetsov YB, Harmon BE, Wilkens LR, Le Marchand L, Haiman C, Reedy J, Boushey CJ. Testing the Predictive Validity of the Healthy Eating Index-2015 in the Multiethnic Cohort: Is the Score Associated with a Reduced Risk of All-Cause and Cause-Specific Mortality? Nutrients. 2018 Apr 5;10(4):452. doi: 10.3390/nu10040452. PMID 29621192
• Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3. PMID 11832252
• Seligman HK, Angell SY, Berkowitz SA, Elkind MSV, Hager K, Moise N, Posner H, Muse J, Odoms-Young A, Ridberg R, Troxel AB, Yaroch AL, Volpp KG. A Systematic Review of "Food Is Medicine" Randomized Controlled Trials for Noncommunicable Disease in the United States: A Scientific Statement From the American Heart Association. Circulation. 2025 Jul 29;152(4):e32-e46. doi: 10.1161/CIR.0000000000001343. PMID 40528749
• Mozaffarian D, Aspry KE, Garfield K, Kris-Etherton P, Seligman H, Velarde GP, Williams K, Yang E; ACC Prevention of Cardiovascular Disease Section Nutrition and Lifestyle Working Group and Disparities of Care Working Group. "Food Is Medicine" Strategies for Nutrition Security and Cardiometabolic Health Equity: JACC State-of-the-Art Review. J Am Coll Cardiol. 2024 Feb 27;83(8):843-864. doi: 10.1016 PMID 38383100

Идентификаторы

NCT: NCT07674979 · STUDY00000327

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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