Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors

NCT06570057 | Recruiting DMC

• 1 other identifier: EMPOWERD-FT-UPK-2022
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.

Conditions

Type II Diabetes Mellitus

Keywords

Community-Based Participatory Research; Participatory Learning and Action Research; Type II Diabetes Mellitus; Intermediate hyperglycemia

Outcome Measures

Primary Outcomes (2)

• Prevalence of Type II Diabetes Mellitus

  HbA1c biochemical test

  18 months

• Two-year cumulative incidence of Type II Diabetes Mellitus

  HbA1c biochemical test

  18 months

Secondary Outcomes (9)

• Mean diastolic and systolic blood pressure

  18 months

• Prevalence of hypertension

  18 months

• Abdominal obesity

  18 months

• Mean body mass index

  18 months

• Health-related quality of life

  18 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Community mobilization will be done via male and female community groups using a PLA Cycle whereby groups themselves identify and priorities problems associated with diabetes and the risk of developing diabetes. Next this study will plan strategies to address the problems identified in the community, put these strategies into practice and, finally, evaluate the effectiveness of these strategies. Lay facilitators will convene the groups monthly over a period of 18 months, with one meeting per month.

Behavioral: Participatory, learning and Action (PLA) Based intervention

Control Group

NO INTERVENTION

The Control Group will not receive the PLA (Participatory Learning and Action) intervention. However, they will still benefit from the study in several ways. Information about the trial and guidance on who to contact in case of hyperglycemia or intermediate hyperglycemia will be provided. The disease burden in the control area will be monitored, and findings will be included in national and international advocacy and dissemination efforts

Interventions

Participatory, learning and Action (PLA) Based intervention BEHAVIORAL

An PLA based intervention would be carried out to prepare the Diabetes Mellitus type II patients. The intervention would be carried out for a tentative time of 2 to 3 hours to educate the type II diabetes mellitus. The study participants would be evaluated after completion of 18 months of the intervention. A structured, validated and literature-based assessment checklist will be devised to assess the effectiveness and feasibility of the intervention.

Intervention Group

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 20 years and above.
• Participants residing in the randomized clusters of Karachi, Pakistan
• Individuals willing to participate in the study and provide consent.
• Both individuals with normoglycemia, intermediate hyperglycemia, 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:

• Individuals below the age of 20 years.
• Individuals unwilling to provide consent for participation.
• Participants with severe health conditions that may hinder their active involvement in the study.
• Individuals with non-compliance with research protocols

Sponsors & Collaborators

• Baqai Institute of Diabetology and Endocrinology: lead
• University of York: collaborator
• Khyber Medical University Peshawar: collaborator
• HealthNet TPO: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• Aga Khan University Hospital, Pakistan: collaborator

Study Sites (1)

Baqai Institute of Diabetology and Endocrinology (BIDE)

Karachi, Sindh, 74600, Pakistan

RECRUITING

Related Publications (2)

• Imtiaz S, Khaleeq N, Sanauddin N, Afaq S, Jennings HM, Tahir A, Abdeali M, Khan Z, Khan F, Zafar R, Khan A, Shahab AR, Ali F, Elsey H, Hassan F, Khan A, Hofiani SMS, Alimi N, Azizi S, Alizoi N, Rahman K, Sheikh A, Basit A, Haq ZU. Community Health Participatory interventions in the prevention and control of non-communicable diseases including mental health in crisis-affected Low-and Middle-Income Countries - a scoping review. Glob Health Action. 2026 Dec;19(1):2599011. doi: 10.1080/16549716.2025.2599011. Epub 2026 Jan 2.

  PMID: 41480977 BACKGROUND

• Imtiaz S, Zafar R, Tahir A, Abdeali M, Ahmed F, Mansoor A, Khan A, Fawwad A, Basit A, Walker S, Afaq S, Rehman K, Khan Z, Kanaan M, Jennings HM, Shahab AR, Siddiqi K, Haq ZU. Engagement of coMmunity through Participatory learning and action for cOntrol and preVEntion of Type 2 Diabetes and its Risk factors (EMPOWER-D): protocol for a feasibility cluster randomised controlled trial in urban Pakistan. Pilot Feasibility Stud. 2026 Feb 3. doi: 10.1186/s40814-025-01762-x. Online ahead of print.

  PMID: 41630102 DERIVED

Related Links

• OSF registration link

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Abdul Basit, Director

  Baqai Institute of Diabetes and Endocrinology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdul Basit, Director

CONTACT

922136688897; abdulbasit@bide.edu.pk

Rubia Zafar, TrialManager

CONTACT

rzafar@bide.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-arm parallel study design would be used. Six clusters will be randomly selected from purely urban blocks of Karachi. The study sites will be selected in a manner that the risk of possible contamination between control and intervention groups is avoided. The intervention clusters will receive the 18-months long PLA intervention along with study assessments, while the control clusters will only go through assessments i.e., at baseline and end of study. A referral mechanism will be followed for both intervention and control arm, which will ensure that the individuals with newly diagnosed diabetes will be referred to the nearest diabetes care facility.

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 26, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• 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

PA (1)