NCT05776420招募中3 期
Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes: a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 390
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
This randomized controlled trial (RCT) will determine if access to a voucher for healthy foods reduces blood sugar levels among people living on a low income who have type 2 diabetes or elevated blood sugar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemoglobin A1c 6.0 to 11.0
- •report food insecurity or financial insecurity
排除标准
- •live with a current study participant
- •life expectancy < 6 months
- •multiple life-threatening allergies to common foods
- •require total parenteral nutrion
- •blood dyscrasia that interferes with hemoglobin A1c interpretation
- •hemoglobin A1c >11
研究组 & 干预措施
Food voucher
Experimental
$65 monthly voucher for healthy foods (phase 1)
干预措施: Food voucher (Behavioral)
Control
No Intervention
Large voucher
Experimental
$160 monthly voucher for healthy foods (phase 2)
干预措施: Food voucher (Behavioral)
Small voucher
Active Comparator
$40 monthly voucher for healthy foods (phase 2)
干预措施: Food voucher (Behavioral)
结局指标
主要结局
Hemoglobin A1c
时间窗: 6 months
Change in hemoglobin A1c
次要结局
- Health care utilization using administrative data(6 months)
- General health ("In general, how would you rate your health today?")(6 months)
- Financial security ("Do you have trouble making ends meet at the end of the month?")(6 months)
- Carotenoid level(6 months)
- Food insecurity measured by 6 questions from Household Food Security Survey(6 months)
- Fruit and vegetable consumption(6 months)
研究者
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