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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorHealthNet Transcultural Psychosocial Organization

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: PLA Intervention groupExperimental treatment 1 intervention
Group B: Usual care (control) groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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HealthNet Transcultural Psychosocial Organization

Lead sponsor

University of York

Collaborator

Khyber Medical University Peshawar

Collaborator

National Institute for Health Research, United Kingdom

Collaborator

Aga Khan University

Collaborator