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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorKhyber Medical University Peshawar

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

12,744 Participants
are divided into 2 treatment groups
Group A: Participatory, Learning and Action (PLA) Based InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
18 months

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
18 months

Other outcomes

1

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.

Time frame
18 months
2

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.

Time frame
18 months
3

Population knowledge about diabetes

Population knowledge about diabetes was assessed using a survey/interview adapted from the DMagic trial at baseline and end-line.

Time frame
18 months

Sponsors and contacts

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Khyber Medical University Peshawar

Lead sponsor

University of York

Collaborator

Baqai Institute of Diabetology and Endocrinology

Collaborator