Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
Healthy Volunteers
ID06570057

Engagement of Community Through Participatory Learning and Action for Control and Prevention of Type II Diabetes and Its Risk Factors: Feasibility Trial in Urban Pakistan

Led by Baqai Institute of Diabetology and Endocrinology · Updated on 2024-08-26

240

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

Sponsors

B

Baqai Institute of Diabetology and Endocrinology

Lead Sponsor

U

University of York

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a Participatory Learning and Action (PLA) based intervention to prevent and control Type II Diabetes Mellitus (TIIDM) and its risk factors in urban Karachi, Pakistan. This approach is adapted from a successful rural trial in Bangladesh and aims to address the growing health emergency of TIIDM, especially in low- and middle-income countries. The study focuses on community engagement to improve social and behavioral health determinants and manage diabetes more effectively in urban settings. The intervention involves community mobilization through male and female groups who meet monthly over 18 months. These groups identify and prioritize diabetes-related issues, plan strategies to address them, implement these strategies, and evaluate their impact. A control group will not receive the PLA intervention but will receive information about the trial and guidance for managing hyperglycemia. This randomized trial compares outcomes between the intervention and control groups. Participants will be assessed over 18 months with evaluations including diabetes prevalence, incidence, blood pressure, obesity, quality of life, and mental health aspects like depression and anxiety. The study includes questionnaires, physical measurements, and validated checks to monitor effectiveness and feasibility. The trial aims to provide insights into adapting PLA interventions in urban environments and contribute to diabetes prevention efforts.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 20 years and above.
  • Residents of the randomized clusters in Karachi, Pakistan.
  • Willingness to participate and provide consent.
  • Includes people with normal blood sugar, intermediate hyperglycemia, or diabetes.
  • Ability to attend scheduled meetings and interventions as required by the study protocol.
Not Eligible

You will not qualify if you...

  • Individuals under 20 years of age.
  • Unwilling to provide consent.
  • Severe health conditions that prevent active participation.
  • Non-compliance with research protocols.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 18 months

Participants in the intervention group attend monthly community group meetings where they engage in participatory learning and action cycles to identify, plan, and address diabetes-related problems.

Monthly meetings over 18 months

Long-term Monitoring

Duration - Assessment at 18 months

Participants are evaluated after the 18-month intervention period to assess the effectiveness and feasibility of the intervention.

1 follow-up visit (in-person) after 18 months

Trial Site Locations

Total: 1 location

1

Baqai Institute of Diabetology and Endocrinology (BIDE)

Karachi, Sindh, Pakistan, 74600

Actively Recruiting

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Research Team

A

Abdul Basit, Director

R

Rubia Zafar, TrialManager

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

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.

Sara Imtiaz, Nadia Khaleeq, Noor Sanauddin...

https://pubmed.ncbi.nlm.nih.gov/41480977

Engaging communities through participatory learning action for the control and prevention of diabetes: A protocol for the Process Evaluation of the EMPOWER-D trial in Pakistan and Afghanistan.

Maria Ishaq Khattak, Khalid Rehman, Saima Afaq...

https://pubmed.ncbi.nlm.nih.gov/42139267

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.

Sara Imtiaz, Rubia Zafar, Amber Tahir...

https://pubmed.ncbi.nlm.nih.gov/41630102