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

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.

Study Overview

• Status: Recruiting
• Conditions: Type II Diabetes Mellitus; Intermediate Hyperglycemia (IHG)
• Intervention / Treatment: Behavioral: Participatory, Learning and Action Based Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 12744
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. Dr Zia Ul Haq, MBBS,MPH,PhD; Phone Number: +92 333 9258763; Email: drzia@kmu.edu.pk
• Study Contact Backup: Name: Khalid Rahman, MBBS,MPH,PHD; Phone Number: +92 333 9432032; Email: drkhalid.iph@kmu.edu.pk

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25100
      • Recruiting
      • Khyber Medical University Peshawar
      • Contact: Dr Khalid Rahman, MBBS,MPH,PHD; Phone Number: +923339432032; Email: drkhalid.iph@kmu.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

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 a history of non-compliance with medical interventions or research protocols

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months
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.	18 months
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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months
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.	18 months
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.	18 months
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.	18 months
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.	18 months
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	18 months
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	18 months
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.	18 months
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	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fruit / vegetable intake	Fruit and vegetable intake frequency was assessed using a Pakistan-validated Food Frequency Questionaire (FFQ) (13) at baseline and endline. The frequency of fruit and vegetable intake will be assessed using a Pakistan-validated Food Frequency Questionnaire (FFQ) and reported as the mean servings per day.	18 months
Hemoglobin	Hemoglobin levels were assessed through Complete Blood Count tests at baseline and endline. The hemoglobin levels will be measured in g/dL using a Complete Blood Count test.	18 months
Population knowledge about diabetes	Population knowledge about diabetes was assessed using a survey/interview adapted from the DMagic trial at baseline and end-line.	18 months

Collaborators and Investigators

• Sponsor: Khyber Medical University Peshawar
• Collaborators: University of York; Baqai Institute of Diabetology and Endocrinology
• Investigators: Principal Investigator: Prof. Dr Zia Ul Haq, MBBS,MPH,PhD, Khyber Medical Univeristy Peshawar; Principal Investigator: Prof. Abdul Basit, MBBS,FRCP, Baqai Institute of Diabetology & Endocrinology, Karachi, Pakistan; Principal Investigator: Zohaib Khan, BDS,MPH,PHD, Khyber Medical University; Principal Investigator: Saima Afaq, MBBS,MPH,PHD, University of York

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 17, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Type II Diabetes Mellitus; Intermediate hyperglycemia; Community-Based Participatory
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: KMU/DIR/CTU/2024/007; NIHR203248 (Other Grant/Funding Number: National Institute for Health and Care Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data requests can be submitted starting 12 months after article publication.
• IPD Sharing Access Criteria: Access can be requested by qualified researchers through proper approval of the investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No