YMCA Produce Prescription Project (YPRx)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •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
排除标准
- •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
结局指标
主要结局
Change in body weight
时间窗: Baseline, 3 months, 6, months, 9 months, and 12 months
Change in body weight will be measured by change in absolute pounds and percent of body weight. Participants will provide self-reported weight in pounds via quarterly online surveys at baseline, 3 months, 6 months, 9 months, and 12 months (endline).
次要结局
- Change in physical activity(Baseline, 3 months, 6, months, 9 months, and 12 months)
- Change in food security status(Baseline and 12 months)
- Change in participant dietary intake(Baseline and 12 months)
- Change in participant food behaviors(Baseline and 12 months)
- Change in personal health self-rated health assessment(Baseline and 12 months)
- Change in participant healthcare utilization- self-reported(Baseline and 12 months)
研究者
Tessa Mork
Association Director of Community Health
YMCA of Metropolitan Washington