Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors
- Conditions
- Type II Diabetes Mellitus
- Interventions
- Behavioral: Participatory, learning and Action (PLA) Based intervention
- Registration Number
- NCT06570057
- Lead Sponsor
- Baqai Institute of Diabetology and Endocrinology
- Brief Summary
This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Participatory, learning and Action (PLA) Based intervention Community mobilization will be done via male and female community groups using a PLA Cycle whereby groups themselves identify and priorities problems associated with diabetes and the risk of developing diabetes. Next this study will plan strategies to address the problems identified in the community, put these strategies into practice and, finally, evaluate the effectiveness of these strategies. Lay facilitators will convene the groups monthly over a period of 18 months, with one meeting per month.
- Primary Outcome Measures
Name Time Method Two-year cumulative incidence of Type II Diabetes Mellitus 18 months HbA1c biochemical test
Prevalence of Type II Diabetes Mellitus 18 months HbA1c biochemical test
- Secondary Outcome Measures
Name Time Method Frequency of depression 18 months Patient Health Questionnaire (PHQ-9)
Mean body fat percentage 18 months Using impedance analyzer
Abdominal obesity 18 months Waist-to-hip circumference ratio
Prevalence of hypertension 18 months Digital BP monitoring
Frequency of anxiety 18 months Generalized Anxiety Disorder (GAD-7) Scale
Prevalence of overweight and obesity 18 months Height and weight will be taken
Mean diastolic and systolic blood pressure 18 months Digital blood pressure monitoring
Mean body mass index 18 months Height and weight will be taken
Health-related quality of life 18 months World Health Organization Quality of Life (WHOQOL) BREF questionnaire
Trial Locations
- Locations (1)
Baqai Institute of Diabetology and Endocrinology (BIDE)
🇵🇰Karachi, Sindh, Pakistan