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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Participatory, learning and Action (PLA) Based intervention
  An PLA based intervention would be carried out to prepare the Diabetes Mellitus type II patients. The intervention would be carried out for a tentative time of 2 to 3 hours to educate the type II diabetes mellitus. The study participants would be evaluated after completion of 18 months of the intervention. A structured, validated and literature-based assessment checklist will be devised to assess the effectiveness and feasibility of the intervention.

Первичные конечные точки

• Prevalence of Type II Diabetes Mellitus [Срок оценки: 18 months]
• Two-year cumulative incidence of Type II Diabetes Mellitus [Срок оценки: 18 months]

Вторичные конечные точки (9)

• Mean diastolic and systolic blood pressure [Срок оценки: 18 months]
• Prevalence of hypertension [Срок оценки: 18 months]
• Abdominal obesity [Срок оценки: 18 months]
• Mean body mass index [Срок оценки: 18 months]
• Health-related quality of life [Срок оценки: 18 months]
• Frequency of depression [Срок оценки: 18 months]
• Mean body fat percentage [Срок оценки: 18 months]
• Prevalence of overweight and obesity [Срок оценки: 18 months]
• Frequency of anxiety [Срок оценки: 18 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Пакистан · 1 центр

• Baqai Institute of Diabetology and Endocrinology (BIDE) — Karachi

Публикации

• Imtiaz S, Khaleeq N, Sanauddin N, Afaq S, Jennings HM, Tahir A, Abdeali M, Khan Z, Khan F, Zafar R, Khan A, Shahab AR, Ali F, Elsey H, Hassan F, Khan A, Hofiani SMS, Alimi N, Azizi S, Alizoi N, Rahman K, Sheikh A, Basit A, Haq ZU. Community Health Participatory interventions in the prevention and control of non-communicable diseases including mental health in crisis-affected Low-and Middle-Income PMID 41480977
• Khattak MI, Rehman K, Afaq S, Butt SS, Ghutai G, Hanifi R, Hofiani M, Tahir A, Zafar R, Jennings HM. Engaging communities through participatory learning action for the control and prevention of diabetes: A protocol for the Process Evaluation of the EMPOWER-D trial in Pakistan and Afghanistan. PLoS One. 2026 May 15;21(5):e0345231. doi: 10.1371/journal.pone.0345231. eCollection 2026. PMID 42139267
• Imtiaz S, Zafar R, Tahir A, Abdeali M, Ahmed F, Mansoor A, Khan A, Fawwad A, Basit A, Walker S, Afaq S, Rehman K, Khan Z, Kanaan M, Jennings HM, Shahab AR, Siddiqi K, Haq ZU. Engagement of coMmunity through Participatory learning and action for cOntrol and preVEntion of Type 2 Diabetes and its Risk factors (EMPOWER-D): protocol for a feasibility cluster randomised controlled trial in urban Pakista PMID 41630102

Идентификаторы

NCT: NCT06570057 · EMPOWERD-FT-UPK-2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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