Lifestyle Intervention to Prevent Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,244
- 试验地点
- 1
- 主要终点
- >7% reduction in weight
研究概览
简要总结
The investigators' general goal is to identify approaches to risk stratification and health promotion through lifestyle modification that are acceptable, effective and efficient for prevention of T2D in South Asian communities from diverse settings.
详细描述
The specific aims of the proposed iHealth-T2D study are:
- Determine whether intensive lifestyle modification vs usual care reduces risk of T2D (primary endpoint) amongst South Asians with i. central obesity; ii. prediabetes and iii. overall (with central obesity and / or obesity).
- Investigate secondary endpoints, including health gains in family members. Identify social, demographic and environmental factors influencing primary and secondary endpoints.
- Carry out a health economic analysis of lifestyle modifications vs usual care for prevention of T2D on the Indian subcontinent and Europe. Quantify the cost-effectiveness of screening by waist circumference vs HbA1c.
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Waist circumference≥100cm OR HbA1c≥6.0%
- •South Asian, Male or Female, and age 40-70 years
排除标准
- •Known type 1 or 2 diabetes
- •Fasting glucose≥7.0 mmol/L or HbA1c ≥6.5%
- •Normal or underweight (body mass index<22kg/m2)
- •Pregnant or planning pregnancy
- •Unstable residence or planning to leave the area
- •Serious illness
- •Lack of capacity to consent
研究组 & 干预措施
Intensive lifestyle modification
The investigators will recruit 3,600 South Asian men and women aged 40-70 years with i. central obesity (waist≥100 cm) and/or ii. prediabetes (HbA1c 6.0-6.4%) to the study (Index cases). Recruitment will be from the Indian subcontinent (India, Pakistan, Sri Lanka) and Europe (UK). Index cases will receive either i. intensive lifestyle modification (N=1,800); or ii. usual care (N=1,800).
Intensive lifestyle modification follows clinically accepted, evidence based strategies to achieve >7% reduction in weight through improved diet and increased physical activity, and is delivered as 9 face-face and 13 telephone contact sessions over 12 months.
Index cases will be followed for three years to identify new-onset T2D.
干预措施: Intensive lifestyle modification (Behavioral)
Usual Care
The investigators will recruit 3,600 South Asian men and women aged 40-70 years with i. central obesity (waist≥100 cm) and/or ii. prediabetes (HbA1c 6.0-6.4%) to the study.
Recruitment will be from the Indian subcontinent (India, Pakistan, Sri Lanka) and Europe (UK). Index cases will receive either i. intensive lifestyle modification (N=1,800); or ii. usual care (N=1,800).
Usual care group will comprise one diabetes prevention session and written material.
结局指标
主要结局
>7% reduction in weight
时间窗: 4 year
The investigators aim to achieve this outcome by motivating study participants to improve diet habits and increase physical activity
次要结局
- Reduction of ≥5 cm waist circumference(4 year)