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

NCT06561126 | Recruiting DMC

• 2 other identifiers: KMU/DIR/CTU/2024/007NIHR203248
• Study Type: interventional
• Target: 12,744
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type II Diabetes Mellitus; Intermediate Hyperglycemia (IHG)

Keywords

Community-Based Participatory; Diabetes Mellitus; Type II Diabetes Mellitus; Intermediate hyperglycemia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Blood pressure (BP)

  18 months

• Prevalence of hypertension

  18 months

• Abdominal obesity

  18 months

• Body mass index (BMI)

  18 months

• Prevalence of overweight & obesity

  18 months

Other Outcomes (3)

• Fruit / vegetable intake

  18 months

• Hemoglobin

  18 months

• Population knowledge about diabetes

  18 months

Study Arms (2)

Participatory, Learning and Action (PLA) Based Intervention

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.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

Usual Care

NO INTERVENTION

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.

Interventions

Participatory, Learning and Action Based Intervention BEHAVIORAL

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.

Participatory, Learning and Action (PLA) Based Intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• University of York: collaborator
• Baqai Institute of Diabetology and Endocrinology: collaborator

Study Sites (1)

Khyber Medical University Peshawar

Peshawar, KPK, 25100, Pakistan

RECRUITING

Related Publications (12)

• 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.

  PMID: 34386215 BACKGROUND

• 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.

  PMID: 30733182 BACKGROUND

• 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.

  PMID: 32546189 BACKGROUND

• 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.

  PMID: 27524396 BACKGROUND

• 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.

  PMID: 22952508 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 32582485 BACKGROUND

• 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.

  PMID: 34639559 BACKGROUND

• 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.

  PMID: 24709231 BACKGROUND

• 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.

  PMID: 30082350 BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

• 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.

  PMID: 41088044 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Non-applicable
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 19, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting 12 months after article publication.
• Access Criteria: Access can be requested by qualified researchers through proper approval of the investigators.

Locations

PA (1)