Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
Healthy Volunteers
ID06561126

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

Led by Khyber Medical University Peshawar · Updated on 2025-09-02

12744

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

K

Khyber Medical University Peshawar

Lead Sponsor

U

University of York

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a Participatory Learning and Action (PLA) based approach to prevent and control Type II Diabetes Mellitus (TIIDM) and Intermediate Hyperglycemia (IHG) in rural areas of Peshawar and Swabi, Pakistan. This approach builds on successful trials in Bangladesh and aims to adapt and assess the intervention's effectiveness and cost-effectiveness specifically for these communities. TIIDM is a rapidly growing health issue worldwide, especially in low- and middle-income countries like Pakistan, making this study highly relevant to improving public health outcomes. The study involves forming community groups divided by gender where members meet monthly for 18 months to identify diabetes-related problems and develop strategies using collaborative activities such as discussions, role-play, and photo voice. A total of 64 groups per district will be formed, each including about 20-30 participants randomly selected from the community. A control group will receive usual care and routine awareness without the PLA intervention, allowing comparison of outcomes between groups. Participants will be engaged throughout the study period with regular meetings and interventions lasting 2 to 3 hours. Researchers will measure the prevalence of TIIDM and IHG, along with secondary outcomes like blood pressure, obesity, depression, and quality of life, after 18 months. The trial's total duration includes follow-up to assess the two-year cumulative incidence of TIIDM. This design fosters community empowerment and aims to improve health behaviors and outcomes related to diabetes in these rural settings.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 20 years and above.
  • Residents of rural areas in Peshawar and Swabi, Pakistan.
  • Willingness to participate and provide informed consent.
  • Includes individuals with normal blood sugar, intermediate hyperglycemia, or diabetes.
  • Ability to attend scheduled meetings and interventions as per the study protocol.
Not Eligible

You will not qualify if you...

  • Individuals younger than 20 years.
  • Unwillingness to provide consent for participation.
  • Severe health conditions that limit active involvement.
  • History of non-compliance with medical treatments or research protocols.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 18 months

Participants join community groups that meet monthly to engage in participatory learning and action cycles focused on identifying and addressing diabetes-related health issues.

Monthly visits for 18 months

Follow-up

Duration - At 18 months after intervention start

Participants are assessed to evaluate the effectiveness and feasibility of the intervention, including health outcomes related to type 2 diabetes and its risk factors.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Khyber Medical University Peshawar

Peshawar, KPK, Pakistan, 25100

Actively Recruiting

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Research Team

P

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

K

Khalid Rahman, MBBS,MPH,PHD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial.

Edward Fottrell, Naveed Ahmed, Joanna Morrison...

https://pubmed.ncbi.nlm.nih.gov/30733182

Intra-cluster and inter-period correlation coefficients for cross-sectional cluster randomised controlled trials for type-2 diabetes in UK primary care.

James Martin, Alan Girling, Krishnarajah Nirantharakumar...

https://pubmed.ncbi.nlm.nih.gov/27524396

World Health Organization Quality-of-Life Scale (WHOQOL-BREF): Analyses of Their Item Response Theory Properties Based on the Graded Responses Model.

Shahrum Vahedi

https://pubmed.ncbi.nlm.nih.gov/22952508

Insufficient Physical Activity and Sedentary Behaviors among Medical Students during the COVID-19 Lockdown: Findings from a Cross-Sectional Study in Pakistan.

Irfan Ullah, Md Saiful Islam, Sajjad Ali...

https://pubmed.ncbi.nlm.nih.gov/34639559

Validation of a food frequency questionnaire for assessing macronutrient and calcium intake in adult Pakistani population.

Romaina Iqbal, Mohammad Ali Haroon, Farhan Javed Dar...

https://pubmed.ncbi.nlm.nih.gov/24709231

Prevalence of diabetes, pre-diabetes and associated risk factors: second National Diabetes Survey of Pakistan (NDSP), 2016-2017.

Abdul Basit, Asher Fawwad, Huma Qureshi...

https://pubmed.ncbi.nlm.nih.gov/30082350