Structured Health interventions to reduce Cardiometabolic Risk among adolescents and young adults in tribal communities in Meghalaya, North-eastern India. A type 2 hybrid Cluster- Randomized Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 4,110
- 试验地点
- 1
- 主要终点
- The primary outcome of interest is ideal/improved cardiometabolic health as
研究概览
简要总结
The proposed research study aims to adapt, implement, and evaluate evidence-based lifestyle intervention program to improve cardiometabolic health among adolescents and young adults in tribal populations of rural Meghalaya, a North-eastern state in India. This study will be undertaken in 40 villages of East Khasi Hills district in Meghalaya, a Northeastern state in India.
We have planned to undertake a hybrid type 2 cluster-randomized trial to evaluate both the effectiveness of the intervention program as well as implementation strategies and outcomes. A cluster-randomized trial will enable comparison of the outcomes between the intervention and control clusters in the real-world setting. The target population will be all adolescents and young adults in that community whose family has at least one cardiovascular risk factor such as Obesity or Diabetes, or hypertension or history of Coronary Artery Disease (CAD) or Cerebrovascular Accident (CVA) After a baseline assessment (Includes baseline anthropometric measures, blood for glucose, growth assessment with growth chart, Lipids, and body composition), the proposed intervention will be implemented over an 18-month period, after which the outcomes will be assessed over a period of up to three years further. Twenty clusters (villages) will be each randomly assigned to the intervention and control conditions. The villages are all from the predominantly tribal populations living in sub district East Khasi hills of Meghalaya. We will implement Community health worker (CHW)-led multicomponent interventions at villages to create an environment that supports the adoption of healthy lifestyle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 24.00 Year(s)（—）
- 性别
- All
入选标准
- •The target population for the community level interventions will be all adolescents and young adults in that community, and for the family and individual level interventions, they will be adolescents and young adults living in at-risk households.
- •We define at-risk households as those which we have already been previously identified from our other ongoing research as having at least one family member with diabetes, hypertension, obesity, dyslipidemia and/or a history of cardiovascular disease in the past.
排除标准
- •Participants will be excluded if they have prior diagnosis of cardiovascular diseases, cancer, epilepsy, arthritis or dementia, or have other conditions that limit physical activity and dietary habits.
- •Pregnant women will also be excluded.
结局指标
主要结局
The primary outcome of interest is ideal/improved cardiometabolic health as
时间窗: At the end of the study at 5 years
measured by American Heart Association’s Life’s Simple, which has been adapted
时间窗: At the end of the study at 5 years
and used in South Asian countries.
时间窗: At the end of the study at 5 years
次要结局
- Secondary outcome measures will include continuous and(categorical measurements of fruit and vegetable consumption, physical activity, waist)
研究者
Felix Jebasingh K
Christian Medical College, Vellore