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NCT06570057 | RECRUITING | Type II Diabetes Mellitus

Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors
Sponsor:

Baqai Institute of Diabetology and Endocrinology

Information provided by (Responsible Party):

Abdul Kabul

Brief Summary:

This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.

Condition or disease

Type II Diabetes Mellitus

Intervention/treatment

Participatory, learning and Action (PLA) Based intervention

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : 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
Actual Study Start Date : 2024-06-24
Estimated Primary Completion Date : 2026-11
Estimated Study Completion Date : 2027-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * 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
Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors

Location Details

NCT06570057

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Locations

RECRUITING

Pakistan, Sindh

Baqai Institute of Diabetology and Endocrinology (BIDE)

Karachi, Sindh, Pakistan, 74600