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NCT Number: NCT07350694

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

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

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type II Diabetes Mellitus

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PLA

Behavioral

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.

Other names: Participatory Learning and Action

Primary outcomes

  1. To culturally adapt PLA-based intervention (D-Magic) for primary prevention and control of TIIDM in rural communities of Afghanistan

    Time frame: 10 months

    The outcome will measure the total number of Participatory Learning and Action (PLA) meetings conducted according to the adapted PLA manual. A total of 40 sessions are planned across four PLA groups (two male groups and two female groups), with 10 sessions per group. This measure will report the number of sessions completed as scheduled.

  2. To test the feasibility of the culturally adapted PLA-based intervention (D-Magic)

    Time frame: 12 months

    Definition: Feasibility is measured by the number of participants attending PLA meetings, reflecting successful delivery and engagement.

    Measurement: Number of attendees (N) and proportion (%) of invited participants attending at least one PLA session.

  3. To test the acceptability of the culturally adapted PLA-based intervention (D-Magic)

    Time frame: 12 months

    Definition: Acceptability is assessed by participant retention across PLA meetings, reflecting continued engagement and satisfaction with the intervention.

    Measurement: Number of participants completing the series of PLA meetings (N) and proportion (%) retained.

Secondary outcomes

  1. To estimate the inter-correlation coefficient to inform future adjustment of sample size

    Time frame: 6 months

    The intra-cluster correlation coefficient (ICC) will be estimated to assess within-cluster similarity. Both measures will provide essential parameters for designing a future full-scale rural trial.

  2. To identify and examine potential Barriers to Implementation of the PLA-Based Intervention

    Time frame: 12 months

    Definition: Barriers to implementing the PLA-based intervention, including logistical, operational, cultural, and community-related challenges.

    Measurement: Identified and assessed through process evaluation using supervisory checklists, supervision reports, meeting minutes, participant feedback, and qualitative data from FGDs and IDIs. Each barrier will be coded and categorized into predefined domains.

    Unit of Measure: Number of unique barriers identified in each category (count) and descriptive summaries.

  3. To identify and examine potential facilitators of Implementation of the PLA-Based Intervention

    Time frame: 12 months

    Definition: Factors that facilitate successful implementation of the PLA-based intervention, including community engagement strategies, mobilizer practices, and contextual supports.

    Measurement: Identified and assessed through process evaluation using the same tools: supervisory checklists, supervision reports, meeting minutes, participant feedback, and qualitative data from FGDs and IDIs. Facilitators will be coded and categorized into predefined domains.

    Unit of Measure: Number of unique facilitators identified in each category (count) and descriptive summaries.

  4. To assess the frequency of Type 2 Diabetes and Intermediate Hyperglycaemia

    Time frame: 12 months

    Type 2 diabetes and intermediate hyperglycaemia will be assessed at baseline and endline of the intervention using biochemical measurements, including fasting blood glucose and HbA1c, based on standard clinical cut-off values.

    Additional cardiometabolic risk factors will be assessed at baseline and endline, including anthropometric measurements (weight and height) and selected behavioural factors collected using standardised questionnaires (Food Frequency Questionnaire, Physical Activity Questionnaire and WHOQOL-BREF). Sociodemographic information will be collected using a structured case report form. Outcomes will be reported as counts and percentages only.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdul Rahman Shahab, MPH

CONTACT

[email protected]

+93786611325

Sayed Murtaza Sadat Hofiani, MPH

CONTACT

[email protected]

+93700555600

Sponsors and collaborators

Lead sponsor

HealthNet Transcultural Psychosocial Organization

Other

Collaborators

  • Aga Khan University
  • Khyber Medical University Peshawar
  • National Institute for Health Research, United Kingdom
  • University of York

Registry information

Official study 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

Acronym: EMPOWER-D-Afg

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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