NCT07350694

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Dec 2024Sep 2027

Study Start

First participant enrolled

December 24, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

November 16, 2025

Last Update Submit

January 11, 2026

Conditions

Keywords

Community-Based Participatory ResearchParticipatory Learning and Action ResearchType II Diabetes MellitusIntermediate hyperglycemia

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    12 months

Secondary Outcomes (4)

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

    6 months

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

    12 months

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

    12 months

  • To assess the frequency of Type 2 Diabetes and Intermediate Hyperglycaemia

    12 months

Study Arms (2)

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.

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.

Interventions

PLABEHAVIORAL

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
PLA Intervention group

Eligibility Criteria

Age20 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth Genders (Male and Female)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthNet TPO, Afghanistan

Kabul, Kabul, 24000, Afghanistan

RECRUITING

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Abdul Rahman Shahab, MPH

    Deputy Country Director, HealthNet TPO, Afghanistan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdul Rahman Shahab, MPH

CONTACT

Sayed Murtaza Sadat Hofiani, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research coordinator, HealthNet TPO

Study Record Dates

First Submitted

November 16, 2025

First Posted

January 20, 2026

Study Start

December 24, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR
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.

Locations