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

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: Type II Diabetes Mellitus
• Intervention / Treatment: Behavioral: Participatory, learning and Action (PLA) Based intervention

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

• Study Contact: Name: Abdul Basit, Director; Phone Number: 922136688897; Email: abdulbasit@bide.edu.pk
• Study Contact Backup: Name: Rubia Zafar, TrialManager; Email: rzafar@bide.edu.pk

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74600
      • Recruiting
      • Baqai Institute of Diabetology and Endocrinology (BIDE)
      • Principal Investigator: Abdul Basit, Director
      • Contact: Rubia Zafar, TrialManager; Phone Number: 922136688897; Email: rzafar@bide.edu.pk
      • Contact: Sara Imtiaz; Email: simtiaz@bide.edu.pk

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	HbA1c biochemical test	18 months
Two-year cumulative incidence of Type II Diabetes Mellitus	HbA1c biochemical test	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

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

• OSF registration link

Study record dates

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: Type II Diabetes Mellitus; Community-Based Participatory Research; Intermediate hyperglycemia; Participatory Learning and Action Research
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• 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