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NCT Number: NCT06570057

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

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baqai Institute of Diabetology and Endocrinology (BIDE)

Karachi, Sindh, 74600, Pakistan

Location status: Recruiting

Location contact

Abdul Basit, Director

PRINCIPAL_INVESTIGATOR

Rubia Zafar, TrialManager

CONTACT

[email protected]

922136688897

Sara Imtiaz

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Prevalence of Type II Diabetes Mellitus

    Time frame: 18 months

    HbA1c biochemical test

  2. Two-year cumulative incidence of Type II Diabetes Mellitus

    Time frame: 18 months

    HbA1c biochemical test

Secondary outcomes

  1. Mean diastolic and systolic blood pressure

    Time frame: 18 months

    Digital blood pressure monitoring

  2. Prevalence of hypertension

    Time frame: 18 months

    Digital BP monitoring

  3. Abdominal obesity

    Time frame: 18 months

    Waist-to-hip circumference ratio

  4. Mean body mass index

    Time frame: 18 months

    Height and weight will be taken

  5. Health-related quality of life

    Time frame: 18 months

    World Health Organization Quality of Life (WHOQOL) BREF questionnaire

  6. Frequency of depression

    Time frame: 18 months

    Patient Health Questionnaire (PHQ-9)

  7. Mean body fat percentage

    Time frame: 18 months

    Using impedance analyzer

  8. Prevalence of overweight and obesity

    Time frame: 18 months

    Height and weight will be taken

  9. Frequency of anxiety

    Time frame: 18 months

    Generalized Anxiety Disorder (GAD-7) Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Abdul Basit, Director

CONTACT

[email protected]

922136688897

Rubia Zafar, TrialManager

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Baqai Institute of Diabetology and Endocrinology

Other

Collaborators

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

Registry information

Official study title

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

Acronym: EMPOWER-D

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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