Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]
NCT ID: NCT06561126
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12744 participants
INTERVENTIONAL
2025-05-01
2026-08-31
Brief Summary
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Type II Diabetes Mellitus (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) \[1\]. Around 80% of people with TIIDM reside in low-and middle-income countries (LMICs), exhausting the already burdened healthcare system \[2\]. The intervention "Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in Bangladesh (DMagic)" has been tested and found effective in the rural context of Bangladesh \[1-3\]. A full trial will be conducted in the rural areas of Peshawar and Swabi, Pakistan.
It is anticipated that with the use of evidence-based approaches, best practices, and meaningful community participation, PLA is expected to enhance social and behavioural determinants of health and subsequent outcomes. This will further pave the way for the control of other NCDs through a similar focused approach.
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Detailed Description
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Scientific evidence has demonstrated PLA to be a cost-effective technique to increase maternal and neonatal survival in low-resource settings like India and Nepal. Moreover, it increased awareness about birth preparedness, improved newborn care practices, and enhanced male participation in maternal and newborn health.
This study will utilize a community group-based PLA approach to tackle TIIDM (adapted from D-Magic Bangladesh). A cluster randomized controlled trial will be conducted to assess the effectiveness of PLA in addressing TIIDM and pre-diabetes in rural areas of Peshawar and Swabi, Pakistan. The PLA approach is instrumental in improving health outcomes and services by fostering collaborative community efforts and empowering the community. This collaborative approach fosters a sense of unity, inclusivity, and shared responsibility, ultimately contributing to improved health outcomes and the overall well-being of the community. However, despite its significant impact PLA has not been adapted or tested in settings elsewhere for the prevention and control of TIIDM.
Objective:
1. To culturally adapt PLA-based intervention (DMagic) for primary prevention and control of TIIDM in rural communities of Pakistan.
2. To assess the effectiveness of culturally adapted PLA-based intervention (adapted from D-Magic trial Bangladesh) on the two-year cumulative incidence of TIIDM in high-risk individuals and the prevalence of IHG and TIIDM in rural settings.
3. To determine the cost-effectiveness of the adapted DMagic intervention in rural settings of Pakistan.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The study sites will be selected in a manner that the risk of possible contamination between control and intervention groups is avoided. The intervention group will receive the PLA intervention, while the control arm will only go through assessments i.e., at baseline and end of study.
PREVENTION
NONE
Study Groups
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Participatory, Learning and Action (PLA) Based Intervention
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.Lay facilitators will convene the groups monthly over a period of 18 months, with one meeting per month. A total of 64 groups will be established in each district, each comprising approximately 20-30 participants, covering an eligible population of 250 to 300 individuals. The total number of participants exposed to the intervention, adapted from the DMagic trial in Bangladesh, will be determined based on random selection from the community. The intervention will focus on participatory groups, with separate groups for males and females to ensure inclusivity and encourage participation from high-risk individuals and those with TIIDM.
Participatory, Learning and Action Based Intervention
The total number of participants exposed to the intervention (adapted from the DMagic trial in Bangladesh) will be determined based on random selection from the community. A 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 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.
Usual Care
The Control Group will not receive the PLA (Participatory Learning and Action) intervention. Study participants in the control group would not be exposed to the training and would be kept in the control group. They would be a group that would receive usual care and routine awareness. 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.
No interventions assigned to this group
Interventions
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Participatory, Learning and Action Based Intervention
The total number of participants exposed to the intervention (adapted from the DMagic trial in Bangladesh) will be determined based on random selection from the community. A 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 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.
Eligibility Criteria
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Inclusion Criteria
* Participants residing in the rural areas of Peshawar and Swabi, 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 unwilling to provide consent for participation.
* Participants with severe health conditions that may hinder their active involvement in the study.
* Individuals with a history of non-compliance with medical interventions or research protocols
20 Years
ALL
Yes
Sponsors
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University of York
OTHER
Baqai Institute of Diabetology and Endocrinology
OTHER
Khyber Medical University Peshawar
OTHER
Responsible Party
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Principal Investigators
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Prof. Dr Zia Ul Haq, MBBS,MPH,PhD
Role: PRINCIPAL_INVESTIGATOR
Khyber Medical Univeristy Peshawar
Prof. Abdul Basit, MBBS,FRCP
Role: PRINCIPAL_INVESTIGATOR
Baqai Institute of Diabetology & Endocrinology, Karachi, Pakistan
Zohaib Khan, BDS,MPH,PHD
Role: PRINCIPAL_INVESTIGATOR
Khyber Medical University
Saima Afaq, MBBS,MPH,PHD
Role: PRINCIPAL_INVESTIGATOR
University of York
Locations
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Khyber Medical University Peshawar
Peshawar, KPK, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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Lam AA, Lepe A, Wild SH, Jackson C. Diabetes comorbidities in low- and middle-income countries: An umbrella review. J Glob Health. 2021 Jul 24;11:04040. doi: 10.7189/jogh.11.04040. eCollection 2021.
Fottrell E, Ahmed N, Morrison J, Kuddus A, Shaha SK, King C, Jennings H, Akter K, Nahar T, Haghparast-Bidgoli H, Khan AKA, Costello A, Azad K. Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Mar;7(3):200-212. doi: 10.1016/S2213-8587(19)30001-4. Epub 2019 Feb 4.
Lee YL, Lim YMF, Law KB, Sivasampu S. Intra-cluster correlation coefficients in primary care patients with type 2 diabetes and hypertension. Trials. 2020 Jun 16;21(1):530. doi: 10.1186/s13063-020-04349-4.
Martin J, Girling A, Nirantharakumar K, Ryan R, Marshall T, Hemming K. Intra-cluster and inter-period correlation coefficients for cross-sectional cluster randomised controlled trials for type-2 diabetes in UK primary care. Trials. 2016 Aug 15;17:402. doi: 10.1186/s13063-016-1532-9.
Vahedi S. World Health Organization Quality-of-Life Scale (WHOQOL-BREF): Analyses of Their Item Response Theory Properties Based on the Graded Responses Model. Iran J Psychiatry. 2010 Fall;5(4):140-53.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Sapra A, Bhandari P, Sharma S, Chanpura T, Lopp L. Using Generalized Anxiety Disorder-2 (GAD-2) and GAD-7 in a Primary Care Setting. Cureus. 2020 May 21;12(5):e8224. doi: 10.7759/cureus.8224.
Ullah I, Islam MS, Ali S, Jamil H, Tahir MJ, Arsh A, Shah J, Islam SMS. Insufficient Physical Activity and Sedentary Behaviors among Medical Students during the COVID-19 Lockdown: Findings from a Cross-Sectional Study in Pakistan. Int J Environ Res Public Health. 2021 Sep 29;18(19):10257. doi: 10.3390/ijerph181910257.
Iqbal R, Haroon MA, Dar FJ, Bilgirami M, Bano G, Khan AH. Validation of a food frequency questionnaire for assessing macronutrient and calcium intake in adult Pakistani population. J Coll Physicians Surg Pak. 2014 Apr;24(4):224-7.
Basit A, Fawwad A, Qureshi H, Shera AS; NDSP Members. Prevalence of diabetes, pre-diabetes and associated risk factors: second National Diabetes Survey of Pakistan (NDSP), 2016-2017. BMJ Open. 2018 Aug 5;8(8):e020961. doi: 10.1136/bmjopen-2017-020961.
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
Rehman K, Tahir A, Imtiaz S, Khan Z, Afaq S, Khan A, Shah I, Kanaan M, Sanauddin N, Khaleeq N, Abdeali M, Walker S, Ahmed F, Jennings HM, Ali S, Fazid S, Shahab AR, Khattak MI, Zafar R, Basit A, Siddiqi K, Haq ZU. Engagement of coMmunity through Participatory learning and action for cOntrol and preVEntion of type II Diabetes and its Risk factors (EMPOWER-D) - A Protocol for a Cluster Randomised Controlled Trial. BMC Public Health. 2025 Oct 14;25(1):3492. doi: 10.1186/s12889-025-24371-y.
Other Identifiers
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NIHR203248
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KMU/DIR/CTU/2024/007
Identifier Type: -
Identifier Source: org_study_id
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