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| Name | Class |
|---|---|
| University of York | OTHER |
| Khyber Medical University Peshawar | OTHER |
| HealthNet TPO | OTHER |
| National Institute for Health Research, United Kingdom |
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This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Community mobilization will be done via male and female community groups using a PLA Cycle whereby groups themselves identify and priorities problems associated with diabetes and the risk of developing diabetes. Next this study will plan strategies to address the problems identified in the community, put these strategies into practice and, finally, evaluate the effectiveness of these strategies. Lay facilitators will convene the groups monthly over a period of 18 months, with one meeting per month. |
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| Control Group | No Intervention | The Control Group will not receive the PLA (Participatory Learning and Action) intervention. However, they will still benefit from the study in several ways. Information about the trial and guidance on who to contact in case of hyperglycemia or intermediate hyperglycemia will be provided. The disease burden in the control area will be monitored, and findings will be included in national and international advocacy and dissemination efforts |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Type II Diabetes Mellitus | HbA1c biochemical test | 18 months |
| Two-year cumulative incidence of Type II Diabetes Mellitus | HbA1c biochemical test | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean diastolic and systolic blood pressure | Digital blood pressure monitoring | 18 months |
| Prevalence of hypertension | Digital BP monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdul Basit, Director | Contact | 922136688897 | abdulbasit@bide.edu.pk | |
| Rubia Zafar, TrialManager | Contact | rzafar@bide.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Abdul Basit, Director | Baqai Institute of Diabetes and Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baqai Institute of Diabetology and Endocrinology (BIDE) | Recruiting | Karachi | Sindh | 74600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41480977 | Background | Imtiaz S, Khaleeq N, Sanauddin N, Afaq S, Jennings HM, Tahir A, Abdeali M, Khan Z, Khan F, Zafar R, Khan A, Shahab AR, Ali F, Elsey H, Hassan F, Khan A, Hofiani SMS, Alimi N, Azizi S, Alizoi N, Rahman K, Sheikh A, Basit A, Haq ZU. Community Health Participatory interventions in the prevention and control of non-communicable diseases including mental health in crisis-affected Low-and Middle-Income Countries - a scoping review. Glob Health Action. 2026 Dec;19(1):2599011. doi: 10.1080/16549716.2025.2599011. Epub 2026 Jan 2. | |
| 42139267 |
| Label | URL |
|---|---|
| OSF registration link | View source |
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Data obtained through this study may be provided to qualified researchers with academic interested in the stated study area after its proper monitoring. Data or samples shared will be coded, with no PHI included. Prior permission of the investigators, participants and concerned departments will be obtained.
Data requests can be submitted starting 12 months after article publication
Access can be requested by qualified researchers through proper approval of the investigators
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| OTHER_GOV |
| Aga Khan University Hospital, Pakistan | OTHER |
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.
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|
| 18 months |
| Abdominal obesity | Waist-to-hip circumference ratio | 18 months |
| Mean body mass index | Height and weight will be taken | 18 months |
| Health-related quality of life | World Health Organization Quality of Life (WHOQOL) BREF questionnaire | 18 months |
| Frequency of depression | Patient Health Questionnaire (PHQ-9) | 18 months |
| Mean body fat percentage | Using impedance analyzer | 18 months |
| Prevalence of overweight and obesity | Height and weight will be taken | 18 months |
| Frequency of anxiety | Generalized Anxiety Disorder (GAD-7) Scale | 18 months |
| Derived |
| Khattak MI, Rehman K, Afaq S, Butt SS, Ghutai G, Hanifi R, Hofiani M, Tahir A, Zafar R, Jennings HM. Engaging communities through participatory learning action for the control and prevention of diabetes: A protocol for the Process Evaluation of the EMPOWER-D trial in Pakistan and Afghanistan. PLoS One. 2026 May 15;21(5):e0345231. doi: 10.1371/journal.pone.0345231. eCollection 2026. |
| 41630102 | Derived | Imtiaz S, Zafar R, Tahir A, Abdeali M, Ahmed F, Mansoor A, Khan A, Fawwad A, Basit A, Walker S, Afaq S, Rehman K, Khan Z, Kanaan M, Jennings HM, Shahab AR, Siddiqi K, Haq ZU. Engagement of coMmunity through Participatory learning and action for cOntrol and preVEntion of Type 2 Diabetes and its Risk factors (EMPOWER-D): protocol for a feasibility cluster randomised controlled trial in urban Pakistan. Pilot Feasibility Stud. 2026 Feb 3;12(1):35. doi: 10.1186/s40814-025-01762-x. |
| D004700 | Endocrine System Diseases |