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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Participatory, learning and Action (PLA) Based intervention
BehavioralAn 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
Trial outcomes
Primary outcomes
Prevalence of Type II Diabetes Mellitus
HbA1c biochemical test
Two-year cumulative incidence of Type II Diabetes Mellitus
HbA1c biochemical test
Secondary outcomes
Mean diastolic and systolic blood pressure
Digital blood pressure monitoring
Prevalence of hypertension
Digital BP monitoring
Abdominal obesity
Waist-to-hip circumference ratio
Mean body mass index
Height and weight will be taken
Sponsors and contacts
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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