Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors (EMPOWER-D)

August 22, 2024 updated by: Abdul Basit, Baqai Institute of Diabetology and Endocrinology

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]: Feasibility Trial in Urban Pakistan

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The pivotal components of this approach include adapting, implementing, and evaluating the Participatory Learning and Action (PLA) based intervention for the prevention and control of Type II diabetes (TIIDM). TIIDM is considered the fastest-growing health emergency, affecting 537 million adults worldwide. Global projections for the year 2045 suggest that a 12.2% rise in TIIDM is anticipated with an additional 11.4% rise for intermediate hyperglycemia (IHG). Around 80% of people with TIIDM reside in low-and middle-income countries (LMICs), exhausting the already burdened healthcare system.

The intervention, adapted from the "Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in Bangladesh (DMagic)" trial, has been tested and found effective in the rural context of Bangladesh. However, PLA-based intervention has not been previously tested in urban communities. Considering the distinct sociocultural environment of urban settings, a feasibility trial will be conducted in urban Karachi, Pakistan.

The feasibility trial will assess the intervention's adaptability and effectiveness in this new context. It is anticipated that the use of evidence-based approaches, best practices, and meaningful community participation through PLA will enhance the social and behavioral determinants of health and lead to improved health outcomes. This approach aims to control TIIDM and pave the way for managing other non-communicable diseases through similar focused interventions.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74600
        • Recruiting
        • Baqai Institute of Diabetology and Endocrinology (BIDE)
        • Principal Investigator:
          • Abdul Basit, Director
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
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.
No Intervention: Control Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Type II Diabetes Mellitus
Time Frame: 18 months
HbA1c biochemical test
18 months
Two-year cumulative incidence of Type II Diabetes Mellitus
Time Frame: 18 months
HbA1c biochemical test
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean diastolic and systolic blood pressure
Time Frame: 18 months
Digital blood pressure monitoring
18 months
Prevalence of hypertension
Time Frame: 18 months
Digital BP monitoring
18 months
Abdominal obesity
Time Frame: 18 months
Waist-to-hip circumference ratio
18 months
Mean body mass index
Time Frame: 18 months
Height and weight will be taken
18 months
Health-related quality of life
Time Frame: 18 months
World Health Organization Quality of Life (WHOQOL) BREF questionnaire
18 months
Frequency of depression
Time Frame: 18 months
Patient Health Questionnaire (PHQ-9)
18 months
Mean body fat percentage
Time Frame: 18 months
Using impedance analyzer
18 months
Prevalence of overweight and obesity
Time Frame: 18 months
Height and weight will be taken
18 months
Frequency of anxiety
Time Frame: 18 months
Generalized Anxiety Disorder (GAD-7) Scale
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baqai Institute of Diabetology and Endocrinology

Collaborators

National Institute for Health Research, United Kingdom
University of York
Aga Khan University Hospital, Pakistan
Khyber Medical University Peshawar
HealthNet TPO

Investigators

  • Principal Investigator: Abdul Basit, Director, Baqai Institute of Diabetes and Endocrinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Imtiaz S, Afaq S, Jennings HM, Tahir A, Sanauddin N, Khaleeq N, et al. Community Health Participatory (CHP) Interventions in the Prevention and Control of Non-communicable Diseases in conflict-affected LMICs- A Scoping Review Protocol [Internet]. OSF; 2024.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMPOWERD-FT-UPK-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interested in the stated study area after its proper monitoring. Data or samples shared will be coded, with no PHI included. Prior permission of the investigators, participants and concerned departments will be obtained.

IPD Sharing Time Frame

Data requests can be submitted starting 12 months after article publication

IPD Sharing Access Criteria

Access can be requested by qualified researchers through proper approval of the investigators

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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