Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]: Feasibility Trial in Urban Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Two-year cumulative incidence of Type II Diabetes Mellitus
研究概览
简要总结
This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.
详细描述
The pivotal components of this approach include adapting, implementing, and evaluating the Participatory Learning and Action (PLA) based intervention for the prevention and control of Type II diabetes (TIIDM). TIIDM is considered the fastest-growing health emergency, affecting 537 million adults worldwide. Global projections for the year 2045 suggest that a 12.2% rise in TIIDM is anticipated with an additional 11.4% rise for intermediate hyperglycemia (IHG). Around 80% of people with TIIDM reside in low-and middle-income countries (LMICs), exhausting the already burdened healthcare system.
The intervention, adapted from the "Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in Bangladesh (DMagic)" trial, has been tested and found effective in the rural context of Bangladesh. However, PLA-based intervention has not been previously tested in urban communities. Considering the distinct sociocultural environment of urban settings, a feasibility trial will be conducted in urban Karachi, Pakistan.
The feasibility trial will assess the intervention's adaptability and effectiveness in this new context. It is anticipated that the use of evidence-based approaches, best practices, and meaningful community participation through PLA will enhance the social and behavioral determinants of health and lead to improved health outcomes. This approach aims to control TIIDM and pave the way for managing other non-communicable diseases through similar focused interventions.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 20 years and above.
- •Participants residing in the randomized clusters of Karachi, Pakistan
- •Individuals willing to participate in the study and provide consent.
- •Both individuals with normoglycemia, intermediate hyperglycemia, and diabetes are encouraged to participate.
- •Participants who can attend the scheduled meetings and interventions as per the study protocol.
排除标准
- •Individuals below the age of 20 years.
- •Individuals unwilling to provide consent for participation.
- •Participants with severe health conditions that may hinder their active involvement in the study.
- •Individuals with non-compliance with research protocols
结局指标
主要结局
Two-year cumulative incidence of Type II Diabetes Mellitus
时间窗: 18 months
HbA1c biochemical test
Prevalence of Type II Diabetes Mellitus
时间窗: 18 months
HbA1c biochemical test
次要结局
- Frequency of depression(18 months)
- Mean body fat percentage(18 months)
- Abdominal obesity(18 months)
- Prevalence of hypertension(18 months)
- Frequency of anxiety(18 months)
- Prevalence of overweight and obesity(18 months)
- Mean diastolic and systolic blood pressure(18 months)
- Mean body mass index(18 months)
- Health-related quality of life(18 months)
研究者
Abdul Basit
Professor
Baqai Institute of Diabetology and Endocrinology
