Diabetes Type 2EMPOWER-D-AfgNCT07350694
Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors
A study testing PLA in people with Diabetes Type 2 and Type II Diabetes Mellitus, run by HealthNet Transcultural Psychosocial Organization at 1 site in Afghanistan.
Trial summary
This project aims to adapt, implement, and evaluate PLA based intervention in Rural Kabul, Afghanistan for TIIDM prevention and control. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2, Type II Diabetes Mellitus
- What is being tested?
- PLA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteAfghanistan
- Study dates
- 24 Dec 2024to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Afghanistan1 site, 1 recruiting
- Recruiting
HealthNet TPO, Afghanistan
Kabul, Kabul, 24000
Abdul Rahman Shahab, MPH, +93786611325, abdul.shahab@hntpo.org
Sayed Murtaza Sadat Hofiani, MPH, +93700555600, rsch.coord@hntpo.org
About this study
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
This project aims to adapt, implement, and evaluate PLA based intervention in Rural Kabul, Afghanistan for TIIDM prevention and control.
Read the 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.
- Conditions
- Diabetes Type 2, Type II Diabetes Mellitus
- Being tested
- PLA
- Keywords
- Community-Based Participatory Research, Participatory Learning and Action Research, Type II Diabetes Mellitus, Intermediate hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLABehavioural
Also called Participatory Learning and Action
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.
| Study group | Role | What they receive |
|---|---|---|
| PLA Intervention group | Experimental | Participatory Learning and Action (PLA) sessions adapted from the D-MAGIC trial (Bangladesh). The PLA intervention will be delivered to community members with type II diabetes to improve diabetes-related outcomes. Sessions will be group-based, lasting approximately 2-3 hours each. Participants in this arm will be followed and evaluated 10 months after the start of the intervention using a structured, validated, literature-based endline assessment checklist to assess feasibility and outcomes. Receives: Behavioral: PLA |
| Usual care (control) group | No intervention | Participants in the control arm will receive standard practice (usual care) and comprehensive information about the project but will not receive the PLA intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To culturally adapt PLA-based intervention (D-Magic) for primary prevention and control of TIIDM in rural communities of Afghanistan
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.
Measured: 10 months
To test the feasibility of the culturally adapted PLA-based intervention (D-Magic)
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.
Measured: 12 months
To test the acceptability of the culturally adapted PLA-based intervention (D-Magic)
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.
Measured: 12 months
Secondary outcomes (4)
To estimate the inter-correlation coefficient to inform future adjustment of sample size
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.
Measured: 6 months
To identify and examine potential Barriers to Implementation of the PLA-Based Intervention
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.
Measured: 12 months
To identify and examine potential facilitators of Implementation of the PLA-Based Intervention
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.
Measured: 12 months
To assess the frequency of Type 2 Diabetes and Intermediate Hyperglycaemia
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start24 Dec 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel study design would be used (Intervention and Control Arms) Study Site Details: 1. province: Kabul 2. districts: (District 1 and 2) 4 clusters: (villages) 2 cluster (intervention arm) and 2 clusters (control arm)
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthNet Transcultural Psychosocial Organization
- Sponsor type
- University, hospital or other
- Collaborators
- University of York, Khyber Medical University Peshawar, National Institute for Health Research, United Kingdom, Aga Khan University
- Responsible party
- Principal investigator, Sayed Murtaza Sayed Murtaza Sadat Hofiani, HealthNet Transcultural Psychosocial Organization
- Investigators
- Abdul Rahman Shahab, MPH, Principal investigator, Deputy Country Director, HealthNet TPO, Afghanistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350694
- Sponsor's protocol ID
- HealthNet TPO, A-12-24-464
- Other IDs
- NIHR 203248
- Acronym
- EMPOWER-D-Afg
- Status last verified
- Jan 2026
- First submitted
- 16 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in the stated study area after its proper monitoring. Data or samples shared will be coded, with no Protected Health Information included. Prior permission of the investigators, participants and concerned departments will be obtained.