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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Pakistan
Khyber Medical University Peshawar
RECRUITING
Peshawar
Contact Information
Primary
Prof. Dr Zia Ul Haq, MBBS,MPH,PhD
drzia@kmu.edu.pk
+92 333 9258763
Backup
Khalid Rahman, MBBS,MPH,PHD
drkhalid.iph@kmu.edu.pk
+92 333 9432032
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 12744
Treatments
Experimental: 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.Lay facilitators will convene the groups monthly over a period of 18 months, with one meeting per month. A total of 64 groups will be established in each district, each comprising approximately 20-30 participants, covering an eligible population of 250 to 300 individuals. 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. The intervention will focus on participatory groups, with separate groups for males and females to ensure inclusivity and encourage participation from high-risk individuals and those with TIIDM.
No_intervention: Usual Care
The Control Group will not receive the PLA (Participatory Learning and Action) intervention. Study participants in the control group would not be exposed to the training and would be kept in the control group. They would be a group that would receive usual care and routine awareness. However, they will still benefit from the study in several ways. Information about the trial and guidance on who to contact in case of hyperglycemia or intermediate hyperglycemia will be provided. The disease burden in the control area will be monitored, and findings will be included in national and international advocacy and dissemination efforts.
Related Therapeutic Areas
Sponsors
Collaborators: Baqai Institute of Diabetology and Endocrinology, University of York
Leads: Khyber Medical University Peshawar

This content was sourced from clinicaltrials.gov