Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]

NCT06561126 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12744

Last updated 2025-09-02

No results posted yet for this study

Summary

This project aims to adapt, implement, and evaluate Participatory Learning and Action (PLA) based intervention in rural areas of KPK, Pakistan which includes Peshawar and Swabi for TIIDM prevention and control. The pivotal components of this approach include adapting, implementing, and evaluating the PLA-based intervention for the prevention and control of Type II diabetes. These components will be tailored to meet the specific needs of two different settings in Peshawar and Swabi, Pakistan.

Type II Diabetes Mellitus (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) \[1\]. Around 80% of people with TIIDM reside in low-and middle-income countries (LMICs), exhausting the already burdened healthcare system \[2\]. The intervention "Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in Bangladesh (DMagic)" has been tested and found effective in the rural context of Bangladesh \[1-3\]. A full trial will be conducted in the rural areas of Peshawar and Swabi, Pakistan.

It is anticipated that with the use of evidence-based approaches, best practices, and meaningful community participation, PLA is expected to enhance social and behavioural determinants of health and subsequent outcomes. This will further pave the way for the control of other NCDs through a similar focused approach.

Conditions

  • Type II Diabetes Mellitus
  • Intermediate Hyperglycemia (IHG)

Interventions

BEHAVIORAL

Participatory, Learning and Action Based Intervention

The total number of participants exposed to the intervention (adapted from the DMagic trial in Bangladesh) will be determined based on random selection from the community. A 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 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.

Sponsors & Collaborators

  • University of York

    collaborator OTHER
  • Baqai Institute of Diabetology and Endocrinology

    collaborator OTHER
  • Khyber Medical University Peshawar

    lead OTHER

Principal Investigators

  • Prof. Dr Zia Ul Haq, MBBS,MPH,PhD · Khyber Medical Univeristy Peshawar

  • Prof. Abdul Basit, MBBS,FRCP · Baqai Institute of Diabetology & Endocrinology, Karachi, Pakistan

  • Zohaib Khan, BDS,MPH,PHD · Khyber Medical University

  • Saima Afaq, MBBS,MPH,PHD · University of York

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-05-30
Completion
2026-08-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06561126 on ClinicalTrials.gov