A Translation Randodomized Trial of Culturally Specific and Cost Effective Life Style Intervention for the Prevention of Type 2 Diabetes in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,564
- 试验地点
- 1
- 主要终点
- Incidence of Type 2 Diabetes
研究概览
简要总结
The Karachi-based Pakistan Diabetes Prevention Study aims to address key issues in the prevention of type 2 diabetes. Approximately 20,000 people From four communities will be screened for diabetes risk factors using a non-invasive diabetes risk-score system. Those found to be at increased risk will be given an oral glucose tolerance test. People who, after the oral glucose tolerance test, are identified as having prediabetes or normal but with risk factors such as raised BMI and/or history of hypertension will have the opportunity to take part in the Pakistan Diabetes Prevention Study lifestyle intervention. This consists of culturally adjusted preventive strategies focusing on diet and physical activity in real-life settings. Another important aspect of this trial will be to assess the impact of urban planning on the prevalence of obesity and diabetes.
详细描述
The aim of this study is to translate the life style intervention project to prevent diabetes into real life settings in Karachi, Pakistan, home to one sixth of the world's population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men and women between 30-64 years of age
排除标准
- •Diagnosed type 1 or type 2 diabetes
- •Pregnancy or presence of chronic disease rendering survival for three years unlikely
- •Any psychological or physical disability to interfere with participation in the study
- •Ischemic heart disease
研究组 & 干预措施
Standard
Pre diabetics randomized to control arm will receive standard life style advice which is given to all pre diabetics seeking medical advice. Group counselling (30 min to 1 hour) will be provided to participants enrolled in control arm in which they will attend one group class at baseline where they will be given basic information on diabetes prevention , weight loss, diet, and exercise consitent with expert recommendations for a healthy life style inclusing losing 5-10% of their excess body weight to reduce their calorie and fat intake and exercising at least 150 minutes per week.
life style intervention arm
This arm would be given aggressive life style intervention in comparison to standard (control) arm. The intervention would consist of nutritional and physical activity advice.
Consists of 5 sessions during the two years course of follow up. Three sessions in the first year (intensive phase), two sessions (maintenance phase) in second year. Overall sessions have a theme with simple selected theoretical background information. Sessions are to be interactive. Selected handouts and pamphlets are given after the session. Teaching material is both available in English and Urdu (local) language.
干预措施: Life style intervention (Behavioral)
结局指标
主要结局
Incidence of Type 2 Diabetes
时间窗: 2 yrs
Incidence of type 2 diabetes based on OGTT, diagnosed by WHO criteria at interim and end of an intervention.
次要结局
- Components of Metabolic syndrome(2 years)
- The impact of city planning on prevalence of obesity and type 2 diabetes(2 years)
研究者
Dr. Asma Ahmed
Assistant Professor
Aga Khan University