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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorBaqai Institute of Diabetology and Endocrinology

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Prevalence of Type II Diabetes Mellitus

HbA1c biochemical test

Time frame
18 months
2

Two-year cumulative incidence of Type II Diabetes Mellitus

HbA1c biochemical test

Time frame
18 months

Secondary outcomes

1

Mean diastolic and systolic blood pressure

Digital blood pressure monitoring

Time frame
18 months
2

Prevalence of hypertension

Digital BP monitoring

Time frame
18 months
3

Abdominal obesity

Waist-to-hip circumference ratio

Time frame
18 months
4

Mean body mass index

Height and weight will be taken

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baqai Institute of Diabetology and Endocrinology

Lead sponsor

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