Fresh Carts for Mom's to Improve Food Security and Glucose Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percentage Change in fasting blood glucose
研究概览
简要总结
This study will look at the benefit of decreasing food insecurity and improving glucose control among women who either report gestational diabetes (GDM) at 20-28-weeks or have type 2 diabetes (T2DM) with a confirmed pregnancy. Participants will receive a grocery prescription with delivery through Instacart at the start of the study or after 12 weeks or frozen medically tailored meals delivered from Door Dash. Researchers will compare the grocery prescription program, MTM (medically tailored meals), relative to standard of care to see if the impact on these food as medicine programs can improve glucose control over 12-weeks as compared to standard of care.
详细描述
Women who have a diagnosis of gestational diabetes (GDM) or type 2 diabetes (T2DM) and who report food insecurity using the Hunger Vital Signs Screener will be recruited to participate in a comparative study across two urban communities. One arm will receive a grocery prescription program from Instacart Health to be spent on eligible healthy food items based on My Diabetes Plate. The other arm will receive 10 frozen medically tailored meals delivered to their door each week. The meals are based on diabetes guidelines and are culturally appropriate. Meals are created by a local nonprofit food pantry, Dare to Care, in Louisville, Kentucky and delivered via a partnership with Door Dash - Project Dash. Women will be recruited initially from a registered nurse who works at the clinic sites. The study team will then enroll participants after eligibility screening and conduct further onboarding into the food as medicine package based on locations.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of gestational diabetes or type 2 diabetes
- •answer affirmative to one of two questions on the Hunger Vital Signs
- •viable pregnancy
- •lives in a service area of Instacart delivery
- •has a phone or computer which allows ordering food for delivery
排除标准
- •Does not speak English
- •Does not have a phone, tablet, or computer to order groceries for Instacart
- •Plans to move within the next 3 months
研究组 & 干预措施
Grocery Prescription Program
Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately
干预措施: Fresh Funds for Mom's (Behavioral)
Standard Medical Care
the delayed control group will receive their usual care through their healthcare provider and then participate in Fresh Funds or MTM after the initial 12-weeks of intervention.
干预措施: Standard Medical care (Behavioral)
MTM (medically tailored frozen meals)
Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash
干预措施: Medically Tailored Frozen Meals (Behavioral)
结局指标
主要结局
Percentage Change in fasting blood glucose
时间窗: baseline and post intervention, approximately 12 weeks
Fasting blood glucose obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart.
次要结局
- Change in food insecurity(baseline and post intervention, approximately 12 weeks)
- Change in self efficacy(baseline and post intervention, approximately 12 weeks)
- Change in blood pressure(baseline and post intervention, approximately 12 weeks)
研究者
Alison Gustafson
Professor
University of Kentucky