The Diabetes Community Lifestyle Improvement Program (D-CLIP): A Translation Randomized Trial of a Culturally Specific Lifestyle Intervention for Diabetes Prevention in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 599
- 试验地点
- 1
- 主要终点
- Diabetes Incidence
研究概览
简要总结
People from the Indian subcontinent are more likely to get diabetes, even at younger ages. The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial if a culturally specific, community-based lifestyle and metformin (for individuals who do not respond to lifestyle change alone) intervention for men and women living in Chennai, India can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle interventions are programs that seek to prevent disease by promoting changes in health behaviors, improved diet, increased physical activity, and weight loss. The results of this program will be used to make policy and public health recommendations, which will result in broader diabetes prevention efforts. The research team hypothesizes that this program will result in improvements in health (diabetes prevention, weight loss, and improvements in other markers of chronic disease) for intervention participants compared to participants in the control arm of the study.
详细描述
Aims: The Diabetes Community Lifestyle Improvement Program (D-CLIP) aims to implement and evaluate in a controlled, randomized trial the effectiveness, cost-effectiveness, and sustainability of a culturally appropriate, low-cost, and sustainable lifestyle intervention for the prevention of type 2 diabetes mellitus in India.
Methods: D-CLIP, a translational research project adapted from the methods and curriculum developed and tested for efficacy in the Diabetes Prevention Program, utilizes innovated methods (a step-wise model of diabetes prevention with lifestyle and metformin added when needed; inclusion of individuals with isolated impaired glucose tolerance, isolated impaired fasting glucose, and both; classes team-taught by professionals and trained community educators) with the goals of increasing diabetes prevention, community acceptability, and long-term dissemination and sustainability of the program. The primary outcome is, diabetes incidence, and secondary outcomes are cost-effectiveness, changes in anthropometric measures, plasma lipids, blood pressure, blood glucose, and HbA1c, and program acceptability and sustainability assessed using a mixed methods approach.
Conclusion: D-CLIP, a low-cost, community-based, research program, addresses the key components of translational research and can be used as a model for prevention of chronic diseases in other low- and middle-income country settings.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Live in or near Chennai, India
- •Aged 20-65 years
- •A BMI >22 kg/m2 and/or a waist circumference >90 cm for men and >80 cm for women
- •No prior diabetes diagnosis, except for gestational diabetes
- •At high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 110 (measured during screening) AND Baseline fasting glucose of 100-125 mg/dL and/or 2-hour post-load glucose of 140-199 mg/dL
- •Willingness to consent to randomization
排除标准
- •Does not fulfill inclusion criteria
- •Currently pregnant or breastfeeding
- •History of or biomarkers indicating heart disease, serious illness, cancer diagnosis in the past 5 years, or other conditions that may impede or prohibit participation in an unsupervised diet change and physical activity program.
研究组 & 干预措施
Standard of Care
Participants randomized to the standard of care group will receive standard lifestyle advice for diabetes prevention consistent with expert recommendations for a healthy lifestyle, including losing 5-10% of their excess body weight, following standard dietary recommendations to reduce calorie and fat intake, and exercising at least 150 minutes per week.
干预措施: Standard of Care (Behavioral)
Lifestyle Intervention
Intervention arm participants will participate in a step-wise model of diabetes prevention with the goal of reducing diabetes risk, primarily through (1) a weight loss of at least 7% and (2) 150 minutes or more per week of moderate level physical activity.
干预措施: Lifestyle Intervention (Behavioral)
结局指标
主要结局
Diabetes Incidence
时间窗: Baseline through end of follow-up (mean follow-up time = 3 years)
At baseline and follow-up visit(s), a 75-g oral glucose tolerance test will be administered to measure both 2-hour post-load glucose (2HG) and fasting plasma glucose (FPG). After the intervention and maintenance periods, blood glucose will be measured by a FPG test. Diabetes is diagnosed by a FPG≥126 mg/dL or a 2HG≥200 mg/dL. Diabetes incidence will be calculated by determining the proportion of individuals progressing from pre-diabetes to diabetes at each time point.
次要结局
- Body Weight(Baseline through end of follow-up (mean follow-up time = 3 years))
- Plasma Lipids(Baseline through end of follow-up (mean follow-up time = 3 years))
- Beta Cell Function(Baseline through end of follow-up (mean follow-up time = 3 years))
- Dietary Intake(aseline through end of follow-up (mean follow-up time = 3 years))
- Program Acceptability(Baseline through end of follow-up)
- Waist circumference(Baseline through end of follow-up (mean follow-up time = 3 years))
- Blood Pressure(Baseline through end of follow-up (mean follow-up time = 3 years))
- Glycosylated hemoglobin (HbA1c)(Baseline through end of follow-up (mean follow-up time = 3 years))
- Cost-effectiveness(Baseline through end of follow-up (mean follow-up time = 3 years))
- Percent Body Fat(Baseline through end of follow-up (mean follow-up time = 3 years))
研究者
Venkat Narayan
Hubert Professor of Global Health and Epidemiology
Emory University