AzTrials
AzTrials

Type II Diabetes MellitusNCT06561126

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]

A study testing Participatory, Learning and Action Based Intervention in people with Type II Diabetes Mellitus and Intermediate Hyperglycemia (IHG), run by Khyber Medical University Peshawar at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This project aims to adapt, implement, and evaluate Participatory Learning and Action (PLA) based intervention in rural areas of KPK, Pakistan which includes Peshawar and Swabi for TIIDM prevention and control. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
What is being tested?
Participatory, Learning and Action Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12,744 participants
Where
1 sitePakistan
Study dates
1 May 2025to 31 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 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.

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 a history of non-compliance with medical interventions or 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.

Prof. Dr Zia Ul Haq, MBBS,MPH,PhD contact

+92 333 9258763

drzia@kmu.edu.pk

Khalid Rahman, MBBS,MPH,PHD contact

+92 333 9432032

drkhalid.iph@kmu.edu.pk

Pakistan1 site, 1 recruiting

  • Khyber Medical University Peshawar

    Peshawar, KPK, 25100

    Dr Khalid Rahman, MBBS,MPH,PHD, +923339432032, drkhalid.iph@kmu.edu.pk

    Recruiting

Other trials in Pakistan

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]: Cluster Randomized Controlled Trial

This project aims to adapt, implement, and evaluate Participatory Learning and Action (PLA) based intervention in rural areas of KPK, Pakistan which includes Peshawar and Swabi for TIIDM prevention and control. The pivotal components of this approach include adapting, implementing, and evaluating the PLA-based intervention for the prevention and control of Type II diabetes. These components will be tailored to meet the specific needs of two different settings in Peshawar and Swabi, Pakistan.

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.

Read the detailed description

The PLA approach has been systematized into a community approach where groups meet together and follow a cycle of activities. This cycle involves problem identification, collaborative strategy planning, implementation, and participatory evaluation. To address community health issues, various strategies including photo voice, group discussions, and role-play have been widely utilized. By leveraging their life experiences, individuals are encouraged to actively participate in these activities, empowering them to identify problems and utilize their skills to develop effective solutions.

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.
Being tested
Participatory, Learning and Action Based Intervention
Keywords
Community-Based Participatory, Diabetes Mellitus, Type II Diabetes Mellitus, Intermediate hyperglycemia
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Participatory, Learning and Action Based InterventionBehavioural

    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.

Study groups in NCT06561126
Study groupRoleWhat they receive
Participatory, Learning and Action (PLA) Based InterventionExperimentalCommunity 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.
Receives: Behavioral: Participatory, Learning and Action Based Intervention
Usual CareNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of Type 2 Diabetes Mellitus

    The study will determine the prevalence of Type 2 Diabetes Mellitus among adults aged 30 years and older by measuring their HbA1c levels at baseline and endline.

    Measured: 18 months

  2. Prevalence of Intermediate Hyperglycemia (IHG)

    The prevalence of Intermediate Hyperglycemia (IHG) will be assessed using HbA1c and Fasting Blood Glucose (FBG) tests at baseline and endline among adults aged 30 years and older.

    Measured: 18 months

  3. 2-year cumulative incidence of Type 2 Diabetes Mellitus

    The study will calculate the proportion of adults aged 30 years and older with IHG at baseline who progress to Type 2 Diabetes Mellitus within two years.

    Measured: 18 months

Secondary outcomes (9)

  1. Blood pressure (BP)

    The study will measure and compare mean diastolic and systolic blood pressure at the Baseline and Endline via the Digital BP apparatus.

    Measured: 18 months

  2. Prevalence of hypertension

    The prevalence of hypertension will be determined based on blood pressure measurements and self-reported antihypertensive medication use among adults aged 30 years and older. Hypertension is defined as BP ≥ 140/90 mmHg or the use of antihypertensive medication.

    Measured: 18 months

  3. Abdominal obesity

    Use waist-to-hip circumference ratio to assess abdominal obesity separately.

    Waist Circumference: Measured in centimeters.

    Hip Circumference: Measured in centimetres.

    Waist-to-Hip Ratio: Calculated from waist and hip measurements. Abdominal obesity will be assessed by measuring the waist-to-hip circumference ratio among adults aged 20 years and older.

    Measured: 18 months

  4. Body mass index (BMI)

    The participant's height will be measured in meters while the weight will be measured in kilograms. Weight and height will be combined to report Body mass index (BMI) in kg/m^2. The study will calculate the mean Body mass index BMI among the population.

    The prevalence of weight categories will be determined based on World Health Organization BMI classifications, with severely underweight defined as a BMI less than 16.0 kg/m², underweight as 16.0 to 18.4 kg/m², normal weight as 18.5 to 24.9 kg/m², overweight as 25.0 to 29.9 kg/m², moderately obese as 30.0 to 34.9 kg/m², severely obese as 35.0 to 39.9 kg/m², and morbidly obese as a BMI of 40.0 kg/m² or higher. The results will be reported as the percentage of the population classified into each category.

    Measured: 18 months

  5. Prevalence of overweight & obesity

    The study will calculate the prevalence of overweight and obesity among the population. Overweight is defined as a Body Mass Index (BMI) of 25.0 to 29.9 kg/m², and obesity is defined as a BMI of 30.0 kg/m² or higher. The results will be reported as the percentage of the population classified into these categories.

    Measured: 18 months

  6. Depression

    Participants will be screened for depression using the Patient Health Questionnaire-9 at baseline and endline. The Patient Health Questionnaire-9 is a depression screening tool. Higher scores indicate more severe depression. Scores are interpreted as follows:

    0-4: Minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression

    Measured: 18 months

  7. Body fat composition

    Mean body fat percentage will be measured using a Body Fat measuring weighing scale at baseline and endline using a Body Fat (BF) measuring weighing scale

    Measured: 18 months

  8. Quality of life of type II diabetes mellitis & Intermediate Hyperglycemia patients

    The Quality of Life for type II diabetes mellitus will be measured using the World Health Organization Quality Of Life questionnaire at baseline and endline. World Health Organization Quality Of Life questionaire scores range from 0 to 100, with higher scores indicating a better quality of life.

    Measured: 18 months

  9. Anxiety

    Participants will be screened for anxiety using the Generalized Anxiety Disorder-7 at baseline and endline. The Generalized Anxiety Disorder-7 is widely recognized and validated for screening and measuring the severity of generalized anxiety disorder. Generalized Anxiety Disorder-7 consists of 7 items, each scored on a scale of 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21. Higher scores indicate more severe anxiety.

    Score Interpretation:

    0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start1 May 2025
  3. Primary completion30 May 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

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
The most commonly 2 armed parallel study design would be used to conduct the current study. The 72 cluster will be randomly allocated to one of the two arms. In the rural settings of Pakistan, two districts of the Khyber Pakhtunkhwa province which includes Peshawar and Swabi have been selected. From each cluster, groups will be formed based on the average population size of 1500 per cluster. This ensures the inclusion of diverse settings for a comprehensive study 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.
Masking
None (open label)
Enrolment
12,744 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561126
Sponsor's protocol ID
KMU/DIR/CTU/2024/007
Other IDs
NIHR203248
Status last verified
Aug 2025
First submitted
7 Aug 2024
Last updated
2 Sep 2025
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

  • 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.

    PubMed 34386215

  • 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.

    PubMed 30733182

  • 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.

    PubMed 32546189

  • 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.

    PubMed 27524396

  • 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.

    PubMed 22952508

  • 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.

    PubMed 11556941

  • 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.

    PubMed 32582485

  • 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.

    PubMed 34639559

  • 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.

    PubMed 24709231

  • 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.

    PubMed 30082350

  • 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.

    PubMed 28851459

  • 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 42139267

  • Tahir A, Sanauddin N, Imtiaz S, Khaleeq N, AbdeAli M, Khan A, Ahmed F, Jennings HM, Zafar R, Rehman K, Shahab AR, Afaq S. Application of the ADAPT Framework to Contextualize a Participatory Learning and Action Community Intervention for the Prevention and Control of Type 2 Diabetes Mellitus in Urban and Rural Settings in Afghanistan and Pakistan: Protocol for Intervention Adaptation. JMIR Res Protoc. 2026 Mar 27;15:e71602. doi: 10.2196/71602.

    PubMed 41894450

  • 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.

    PubMed 41088044

Questions about this trial

What is this clinical trial studying?

A study testing Participatory, Learning and Action Based Intervention in people with Type II Diabetes Mellitus and Intermediate Hyperglycemia (IHG), run by Khyber Medical University Peshawar at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Prof. Dr Zia Ul Haq, MBBS,MPH,PhD (+92 333 9258763, drzia@kmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Type 2 Diabetes Mellitus (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06561126, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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