Type II Diabetes Mellitus
Conditions
Keywords
Community-Based Participatory Research, Participatory Learning and Action Research, Type II Diabetes Mellitus, Intermediate hyperglycemia
Brief summary
This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.
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.
Interventions
BEHAVIORALParticipatory, 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.
Sponsors
University of York
Khyber Medical University Peshawar
HealthNet TPO
National Institute for Health Research, United Kingdom
Aga Khan University Hospital, Pakistan
Baqai Institute of Diabetology and Endocrinology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Two-arm parallel study design would be used. Six clusters will be randomly selected from purely urban blocks of Karachi. The study sites will be selected in a manner that the risk of possible contamination between control and intervention groups is avoided. The intervention clusters will receive the 18-months long PLA intervention along with study assessments, while the control clusters will only go through assessments i.e., at baseline and end of study. A referral mechanism will be followed for both intervention and control arm, which will ensure that the individuals with newly diagnosed diabetes will be referred to the nearest diabetes care facility.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Type II Diabetes Mellitus | 18 months | HbA1c biochemical test |
| Two-year cumulative incidence of Type II Diabetes Mellitus | 18 months | HbA1c biochemical test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal obesity | 18 months | Waist-to-hip circumference ratio |
| Mean body mass index | 18 months | Height and weight will be taken |
| Health-related quality of life | 18 months | World Health Organization Quality of Life (WHOQOL) BREF questionnaire |
| Mean diastolic and systolic blood pressure | 18 months | Digital blood pressure monitoring |
| Mean body fat percentage | 18 months | Using impedance analyzer |
| Prevalence of overweight and obesity | 18 months | Height and weight will be taken |
| Frequency of anxiety | 18 months | Generalized Anxiety Disorder (GAD-7) Scale |
| Frequency of depression | 18 months | Patient Health Questionnaire (PHQ-9) |
| Prevalence of hypertension | 18 months | Digital BP monitoring |
Countries
Pakistan
Contacts
Primary ContactAbdul Basit, Director
Backup ContactRubia Zafar, TrialManager
Outcome results
None listed