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Recruiting NCT07350694

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors

No phase Interventional Diabetes Type 2 Type II Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PLA.
Who it may be relevant to
Registry conditions: Diabetes Type 2, Type II Diabetes Mellitus. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Afghanistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D-Afg]: Feasibility Trial in Rural Kabul-Afghanistan

Overview

This project aims to adapt, implement, and evaluate PLA based intervention in Rural Kabul, Afghanistan for TIIDM prevention and control.

Detailed description

This approach centres on adapting, implementing, and evaluating a Participatory Learning and Action (PLA) based intervention for the prevention and control of Type II Diabetes. Mellitus (TIIDM). TIIDM is one of the fastest-growing health emergencies globally, affecting an estimated 589 million adults, with projections for 2050 indicating a 45% increase in diabetes. Approximately 80% of people with TIIDM live in low- and middle-income countries (LMICs), placing further strain on already overburdened health systems.

Afghanistan shows similarly concerning trends, with an age-standardised diabetes prevalence of 11.7%, affecting 1.93 million adults in 2024 and projected to rise to 4.76 million by 2050, with 71.4% remaining undiagnosed. Prevalence rises sharply with age and varies by province for example, approximately 11% in Kabul, 11.8% in Nangarhar, and over 22% in Kandahar. These figures highlight the urgency of developing culturally appropriate and evidence-based interventions to prevent and control diabetes in Afghan communities.

The intervention draws on evidence from the "Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic)" trial, which proved effective in rural Bangladesh. However, PLA-based interventions have yet to be tested in rural Afghan communities. Recognizing the distinct sociocultural context, geopolitical and health system challenges in rural Kabul, Afghanistan, a feasibility trial will be carried out in selected rural sites of Kabul Province.

This feasibility trial will evaluate the adaptability and implementation of the intervention within Afghanistan's context. By applying evidence-based practices and fostering meaningful community participation through PLA, the initiative aims to improve social and behavioural determinants of health, enhance diabetes prevention and control, and create a model for addressing other non-communicable diseases in Afghan communities.

Interventions

  • Behavioral PLA
    An PLA based intervention would be carried out to prepare the individuals with TIIDM. The intervention would be carried out for a tentative time of 2 to 3 hours to educate the community. The study participants would be evaluated after completion of 10 months of the intervention. A structured, validated and literature-based end line assessment checklist will be devised to assess the feasibility of the intervention.

Primary outcome measures

  • To culturally adapt PLA-based intervention (D-Magic) for primary prevention and control of TIIDM in rural communities of Afghanistan [Time frame: 10 months]
  • To test the feasibility of the culturally adapted PLA-based intervention (D-Magic) [Time frame: 12 months]
  • To test the acceptability of the culturally adapted PLA-based intervention (D-Magic) [Time frame: 12 months]
Secondary outcome measures (4)
  • To estimate the inter-correlation coefficient to inform future adjustment of sample size [Time frame: 6 months]
  • To identify and examine potential Barriers to Implementation of the PLA-Based Intervention [Time frame: 12 months]
  • To identify and examine potential facilitators of Implementation of the PLA-Based Intervention [Time frame: 12 months]
  • To assess the frequency of Type 2 Diabetes and Intermediate Hyperglycaemia [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • For intervention phase: Individuals aged 20 years and above. For baseline and endline assessments (before and after the intervention): Individuals aged 30 years and above.
  • Participants residing in the randomized clusters of Kabul, Afghanistan Individuals willing to participate in the study and provide consent.
  • All individuals with normoglycemia, intermediate hyperglycaemia, and diabetes are encouraged to participate.
  • Participants who can attend the scheduled meetings and interventions as per the study protocol.

Exclusion criteria

  • For Intervention phase: Individuals below the age of 20 years. For baseline and endline assessments (before and after the intervention): individuals below the age of 30 years.
  • Individuals unwilling to provide consent for participation.
  • Participants with reported health conditions that may hinder their active involvement in the study.
  • Individuals with non-compliance with research protocols

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Afghanistan · 1 center
  • HealthNet TPO, Afghanistan — Kabul

Identifiers

NCT: NCT07350694 · HealthNet TPO, A-12-24-464 · NIHR 203248

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗