YMCA Produce Prescription Project (YPRx)

Обзор

In this randomized control study, participants will be randomized 1:1 to either participate in the YMCA's Produce Prescription Program (YPRx) and receive weekly deliveries of fresh produce bags for their household or to receive YPRx plus participate in the Diabetes Prevention Program (DPP). The investigators hypothesize that participants randomized to receive YPRx plus DPP will have greater weight loss, increased physical activity, improved diet quality and behaviors, increased food security, improved self-rated health assessment, decreased healthcare utilization from baseline to endline (12 months) compared to those randomized to receive YPRx produce deliveries only. We will also collect data on process measures for implementation purposes.

Подробное описание

This study is a randomized control trial testing the impact of adding disease-specific, evidence-based health education (DPP) to produce prescriptions (YPRx) on participants' health. DPP is a 12-month diabetes prevention behavioral weight loss program developed by the Centers for Disease Control and Prevention and implemented nationwide. In this study, investigators will test whether the addition of health education, coaching, and peer support through DPP improves the effectiveness of YPRx. This trial will take place in the Washington D.C. Metropolitan Area in collaboration with the YMCA of Metropolitan Washington, a provider of DPP and YPRx, Hungry Harvest, a purveyor of produce deliveries, and Amerigroup/Elevance Health, a Medicaid managed care organization. Participants will be randomized 1:1 to either participate in YPRx only or to participate in YPRx plus the DPP. The length of the trial will be 12 months for each participant, and outcomes will be measured at baseline, 4 weeks, 3 months, 6 months, 9 months, and 12 months.

Вмешательства

• Поведенческое YMCA Produce Rx (YPRx) Program Only (Control)
  Participants in the control group will receive weekly, home-delivered produce bags of fresh vegetables and fruits and sized for each participants' household. Produce deliveries will be administered for 52 weeks.
• Поведенческое YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP)
  Participants will receive weekly, home-delivered produce bags of fresh vegetables and fruits and sized for each participants' household. Produce deliveries will be administered for 52 weeks. Additionally, participants will be registered for a free, year-long YMCA membership and enrolled in the DPP. Through the DPP, participants will receive health education, coaching, and peer support via 26 virtual group sessions over a year.

Первичные конечные точки

• Change in body weight [Срок оценки: Baseline, 3 months, 6, months, 9 months, and 12 months]

Вторичные конечные точки (6)

• Change in physical activity [Срок оценки: Baseline, 3 months, 6, months, 9 months, and 12 months]
• Change in food security status [Срок оценки: Baseline and 12 months]
• Change in participant dietary intake [Срок оценки: Baseline and 12 months]
• Change in participant food behaviors [Срок оценки: Baseline and 12 months]
• Change in personal health self-rated health assessment [Срок оценки: Baseline and 12 months]
• Change in participant healthcare utilization- self-reported [Срок оценки: Baseline and 12 months]

Критерии участия

Критерии включения

• Over the age of 18
• Recipient of Medicaid through Amerigroup
• Has never been diagnosed with type I or type II diabetes
• Access to laptop, computer, or phone with internet, or willing to use a provided device
• District of Columbia resident
• Available to attend DPP classes at the scheduled recurring day and time
• Not pregnant

Критерии исключения

• Under the age of 18
• Not a recipient of Medicaid through Amerigroup
• Has been diagnosed with type I or type II diabetes
• No access to laptop, computer, or phone with internet
• Not a resident of the District of Columbia
• Cannot attend DPP classes at the scheduled recurring day and time
• Pregnant

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• YMCA of Metropolitan Washington — Washington D.C.

Идентификаторы

NCT: NCT06695104 · 00022594 · 2022-70424-38459

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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