RecruitingNot ApplicableNCT06561126

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

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


Sponsor

Khyber Medical University Peshawar

Enrollment

12,744 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Inclusion Criteria5

  • Individuals aged 20 years and above.
  • Participants residing in the rural areas of Peshawar and Swabi, 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 Criteria4

  • 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 a history of non-compliance with medical interventions or research protocols

Interventions

BEHAVIORALParticipatory, 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.


Locations(1)

Khyber Medical University Peshawar

Peshawar, KPK, Pakistan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06561126


Related Trials