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
Sara Imtiaz
CONTACT
NCT Number: NCT06570057
This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Karachi, Sindh, 74600, Pakistan
Location status: Recruiting
Abdul Basit, Director
PRINCIPAL_INVESTIGATOR
Rubia Zafar, TrialManager
CONTACT
Sara Imtiaz
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 18 months
HbA1c biochemical test
Time frame: 18 months
HbA1c biochemical test
Time frame: 18 months
Digital blood pressure monitoring
Time frame: 18 months
Digital BP monitoring
Time frame: 18 months
Waist-to-hip circumference ratio
Time frame: 18 months
Height and weight will be taken
Time frame: 18 months
World Health Organization Quality of Life (WHOQOL) BREF questionnaire
Time frame: 18 months
Patient Health Questionnaire (PHQ-9)
Time frame: 18 months
Using impedance analyzer
Time frame: 18 months
Height and weight will be taken
Time frame: 18 months
Generalized Anxiety Disorder (GAD-7) Scale
Contact information is provided by the study sponsor or research team.
Abdul Basit, Director
CONTACT
Rubia Zafar, TrialManager
CONTACT
Baqai Institute of Diabetology and Endocrinology
Other
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
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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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