Shanghai Community Prediabetes Standardized Management Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,500
- 试验地点
- 53
- 主要终点
- Change of BMI from baseline at 12 months
研究概览
简要总结
Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Explore the standardized management model for prediabetes participants within primary healthcare settings in Shanghai, to reduce the risk factors of diabetes, improve the blood glucose control, and the quality of life of participants with prediabetes.
详细描述
Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Explore the standardized management model for prediabetes participants within primary healthcare settings in Shanghai, to reduce the risk factors of diabetes, improve the blood glucose control, and the quality of life of participants with prediabetes.
Through the collaboration the Shanghai Municipal Center for Disease Control & Prevention network, this investigators will implement prediabetes screening and lifestyle intervention in around 50 community health service centers in Shanghai. Life-style interventions including exercise and diet, and diabetes prevention knowledge will be integrated into "train-the-trainers" workshops. Trainings will be provided to community health service staff and peer supporters or social workers.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese residents
- •Adult age ≥ 18 years old, 35-75 years old preferred
- •Participants receiving prediabetes management of the basic public health services package in community health centers
- •BMI≥24 kg/m2 or central obesity (Waist circumference≥90 cm in males，Waist circumference≥85 cm in females) or Hypertension (SBP≥140 mmHg and/or DBP≥90 mmHg) preferred
- •Signed informed consents and willing to participate
排除标准
- •With serious chronic diseases, tumors, acute and chronic infectious diseases, limb movement disorders, and any mental illnesses
- •Women during pregnancy or breastfeeding
- •With excessive drinking or illicit drug use
- •Unwilling to participate in the project
- •Histories of severe cardiovascular events (myocardial infarction, stroke, acute coronary syndrome, or transient ischemic attack (TIA))
结局指标
主要结局
Change of BMI from baseline at 12 months
时间窗: Baseline, 12 months
body mass index, using the examination results of height (cm) and weight (kg)
次要结局
- Change of Triglyceride from baseline at 12 months(Baseline, 12 months)
- Change of HbA1c from baseline at 12 months(Baseline, 12 months)
- Change of Fasting Plasma Glucose from baseline at 12 months(Baseline, 12 months)
- Change of Low density lipoprotein cholesterol from baseline at 12 months(Baseline, 12 months)
- Change of Waist circumference from baseline at 12 months(Baseline, 12 months)
- Change of High density lipoprotein cholesterol from baseline at 12 months(Baseline, 12 months)
- Change of Blood Pressure from baseline at 12 months(Baseline, 12 months)
- Change of Total Cholesterol from baseline at 12 months(Baseline, 12 months)
研究者
Weiping Jia
Professor, Director of Shanghai Diabetes Institute
Shanghai 6th People's Hospital