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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06561126
Enrollment
12744
Registered
2024-08-19
Start date
2025-05-01
Completion date
2026-08-31
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermediate Hyperglycemia (IHG), Type II Diabetes Mellitus

Keywords

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

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.

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.

Interventions

BEHAVIORALParticipatory, 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.

Sponsors

University of York
CollaboratorOTHER
Baqai Institute of Diabetology and Endocrinology
CollaboratorOTHER
Khyber Medical University Peshawar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Non-applicable

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Intermediate Hyperglycemia (IHG)18 monthsThe 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.
Prevalence of Type 2 Diabetes Mellitus18 monthsThe 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.
2-year cumulative incidence of Type 2 Diabetes Mellitus18 monthsThe 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.

Secondary

MeasureTime frameDescription
Abdominal obesity18 monthsUse 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.
Body mass index (BMI)18 monthsThe 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.
Depression18 monthsParticipants 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
Body fat composition18 monthsMean 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
Quality of life of type II diabetes mellitis & Intermediate Hyperglycemia patients18 monthsThe 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.
Anxiety18 monthsParticipants 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
Prevalence of overweight & obesity18 monthsThe 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.
Blood pressure (BP)18 monthsThe study will measure and compare mean diastolic and systolic blood pressure at the Baseline and Endline via the Digital BP apparatus.
Prevalence of hypertension18 monthsThe 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.

Other

MeasureTime frameDescription
Fruit / vegetable intake18 monthsFruit 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.
Population knowledge about diabetes18 monthsPopulation knowledge about diabetes was assessed using a survey/interview adapted from the DMagic trial at baseline and end-line.
Hemoglobin18 monthsHemoglobin 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.

Countries

Pakistan

Contacts

Primary ContactProf. Dr Zia Ul Haq, MBBS,MPH,PhD
drzia@kmu.edu.pk+92 333 9258763
Backup ContactKhalid Rahman, MBBS,MPH,PHD
drkhalid.iph@kmu.edu.pk+92 333 9432032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 17, 2026