Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]
NCT Number: NCT06561126
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type II Diabetes Mellitus|Intermediate Hyperglycemia (IHG)
Interventions: BEHAVIORAL: Participatory, Learning and Action Based Intervention
Sponsor: Khyber Medical University Peshawar
Collaborators: University of York|Baqai Institute of Diabetology and Endocrinology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12744
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-08-31

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.

Primary Outcome Measures: 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: 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|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|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: 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