Adapting the Diabetes Prevention Program for a Developing World Context
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
This study will examine whether an adapted version of ]he Diabetes Prevention Program (DPP) can be effective when delivered by community health workers (CHWs) in a poor urban community in South Africa. We will randomize existing groups that are part of an non-governmental organization's (NGO) chronic disease management program (anticipated cluster N = 54; anticipated individual N=540), to receive either the program or usual care (wait-list). The primary outcome analysis will compare percentage of baseline weight loss at Y1 between the program and usual care; however, after Y1 usual care participants will also receive the program and both groups will be followed for another year.
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
- 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
- •member of participating partner NGO "health club" (members are medically stabilized individuals with diabetes mellitus or hypertension referred for disease and lifestyle management)
- •BMI greater than or equal to 25 kg per meter squared
排除标准
- •unsafe level of blood pressure (greater than or equal to 160 (systolic) and greater than equal to 100 mm (diastolic)) at screening
- •elevated blood sugar (A1C greater than 11) at screening
- •being pregnant, breast-feeding or planning pregnancy within 2 years
- •chronic use of oral steroid medication
- •intellectual disabilities that would prevent ability to understand the program
- •not intending to stay in the health club over the next 2 years
研究组 & 干预措施
Lifestyle Program Intervention
Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.
干预措施: Lifestyle Program (Behavioral)
Lifestyle Program Intervention
Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.
干预措施: Usual Care (Other)
Wait list
Participants receive usual care and after 1 year receive the Lifestyle Program intervention
干预措施: Usual Care (Other)
结局指标
主要结局
Weight loss
时间窗: 1 year
percentage weight loss (weight measured in kilograms)
次要结局
- HbA1c(1 year)
- LDL cholesterol(1 year)
- Triglycerides(1 year)
- Blood pressure(1 year)