Type II Diabetes MellitusEMPOWER-DNCT06570057
Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors
A study testing Participatory, learning and Action (PLA) Based intervention in people with Type II Diabetes Mellitus, run by Baqai Institute of Diabetology and Endocrinology at 1 site in Pakistan.
Trial summary
This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- Participatory, learning and Action (PLA) Based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Jun 2024to Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rubia Zafar, TrialManager contact
Pakistan1 site, 1 recruiting
- Recruiting
Baqai Institute of Diabetology and Endocrinology (BIDE)
Karachi, Sindh, 74600
Rubia Zafar, TrialManager, 922136688897, rzafar@bide.edu.pk
Sara Imtiaz, simtiaz@bide.edu.pk
About this study
Official title: 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
This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.
Read the 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.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Participatory, learning and Action (PLA) Based intervention
- Keywords
- Community-Based Participatory Research, Participatory Learning and Action Research, Type II Diabetes Mellitus, Intermediate hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory, learning and Action (PLA) Based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Participatory, learning and Action (PLA) Based intervention |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Type II Diabetes Mellitus
HbA1c biochemical test
Measured: 18 months
Two-year cumulative incidence of Type II Diabetes Mellitus
HbA1c biochemical test
Measured: 18 months
Secondary outcomes (9)
Mean diastolic and systolic blood pressure
Digital blood pressure monitoring
Measured: 18 months
Prevalence of hypertension
Digital BP monitoring
Measured: 18 months
Abdominal obesity
Waist-to-hip circumference ratio
Measured: 18 months
Mean body mass index
Height and weight will be taken
Measured: 18 months
Health-related quality of life
World Health Organization Quality of Life (WHOQOL) BREF questionnaire
Measured: 18 months
Frequency of depression
Patient Health Questionnaire (PHQ-9)
Measured: 18 months
Mean body fat percentage
Using impedance analyzer
Measured: 18 months
Prevalence of overweight and obesity
Height and weight will be taken
Measured: 18 months
Frequency of anxiety
Generalized Anxiety Disorder (GAD-7) Scale
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start24 Jun 2024
- Primary completionNov 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baqai Institute of Diabetology and Endocrinology
- Sponsor type
- University, hospital or other
- Collaborators
- University of York, Khyber Medical University Peshawar, HealthNet TPO, National Institute for Health Research, United Kingdom, Aga Khan University Hospital, Pakistan
- Responsible party
- Principal investigator, Abdul Basit, Baqai Institute of Diabetology and Endocrinology
- Investigators
- Abdul Basit, Director, Principal investigator, Baqai Institute of Diabetes and Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570057
- Sponsor's protocol ID
- EMPOWERD-FT-UPK-2022
- Acronym
- EMPOWER-D
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Imtiaz S, Afaq S, Jennings HM, Tahir A, Sanauddin N, Khaleeq N, et al. Community Health Participatory (CHP) Interventions in the Prevention and Control of Non-communicable Diseases in conflict-affected LMICs- A Scoping Review Protocol [Internet]. OSF; 2024.
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.
PubMed 42139267Imtiaz 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.
PubMed 41630102