An interventional study of PLA in Diabetes Type 2 and Type II Diabetes Mellitus, sponsored by HealthNet Transcultural Psychosocial Organization. Recruiting at 1 site in Afghanistan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by HealthNet Transcultural Psychosocial Organization · Not applicable, Interventional, and Prevention
This project aims to adapt, implement, and evaluate PLA based intervention in Rural Kabul, Afghanistan for TIIDM prevention and control.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 250 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with HealthNet Transcultural Psychosocial Organization as lead sponsor.
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Exclusion Criteria:
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.
Behavioral: PLA
Participants in the control arm will receive standard practice (usual care) and comprehensive information about the project but will not receive the PLA intervention.
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.
Also known as: Participatory Learning and Action
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Plan to share: 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.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Data requests can be submitted starting 12 months after article publication
Access criteria: Access can be requested by qualified researchers through proper approval of the investigators.
Started Dec 2024 (actual). Primary completion is estimated for Nov 2026, 23 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 23 months is close to that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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