跳至主要内容
临床试验/NCT06570057
NCT06570057招募中不适用

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

Baqai Institute of Diabetology and Endocrinology2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年6月24日最近更新:
适应症

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

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

发起方
Baqai Institute of Diabetology and Endocrinology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdul Basit

Professor

Baqai Institute of Diabetology and Endocrinology

研究点 (2)

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