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临床试验/NCT03246997
NCT03246997已完成不适用

Project Powerfood: Promoting Food Security, Equity, and Health

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2017年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
Number of farm shares picked-up

研究概览

简要总结

Project Powerfood is a pilot program aimed at addressing food insecurity and food access in primary care through the implementation of a food prescription program in collaboration with a number of community partners. The objectives of this project are:

  1. Implement screening for food insecurity in adult and pediatric primary care practices at Mount Sinai.

  2. Provide fresh fruit and vegetable "prescriptions" to be redeemed for farm shares from local partner, the Corbin Hill Food Project. Prescriptions will provide 50% off of a fruit and vegetable box. Participants will have the option to purchase 2 boxes per month for 6 months.

  3. Pilot prescriptions with 50 adult patients with poorly-controlled diabetes and 50 obese children who are food insecure and/or receive SNAP and/or WIC benefits. Examine/evaluate:

  4. Feasibility of program in a busy primary care practice

  5. Outcomes before and after the intervention (at baseline, 6 and 12 months), including diet, diabetes control, and body mass index (BMI)

  6. Outcomes in a comparison group (that will receive the food prescriptions beginning at 6 months)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Food insecure and/or receive SNAP and/or WIC
  • Adult patients: poorly-controlled diabetes (hemoglobin A1c greater than 8.0%)
  • Pediatric patients: obesity, ages 5-11
  • Speak English or Spanish

排除标准

  • Food secure and do not receive SNAP or WIC
  • Adult Patients: do not have diabetes
  • Pediatric Patients: not obese, under 5 years old or between 11 and 18
  • Speak neither English or Spanish
  • Severe kidney disease (Chronic Kidney Disease (CKD Stage IV or V)

研究组 & 干预措施

Spring Group

Other

Delayed Intervention

干预措施: Spring Group (Other)

Autumn Group

Other

Intervention Group

干预措施: Autumn Group (Other)

结局指标

主要结局

Number of farm shares picked-up

时间窗: up to 12 months

Number of farm shares picked-up

Overall satisfaction score

时间窗: up to 12 months

overall satisfaction with the program measured by likelihood of recommending the program to a friend on a 4 point scale 1 = not likely at all, 2 = somewhat likely, 3 = likely 4 = very likely

次要结局

  • Health Eating Index(up to 12 months)
  • USDA US Household Food Security Survey(up to 12 months)
  • Hemoglobin A1c level(up to 12 months)
  • The Stanford Patient Education Research Center Diabetes Self-Efficacy Scale(up to 12 months)
  • Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky(up to 12 months)
  • BMI(up to 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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