Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]
- Conditions
- Type II Diabetes MellitusIntermediate Hyperglycemia (IHG)
- Interventions
- Behavioral: Participatory, Learning and Action Based Intervention
- Registration Number
- NCT06561126
- Lead Sponsor
- Khyber Medical University Peshawar
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 12744
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participatory, Learning and Action (PLA) Based Intervention Participatory, Learning and Action Based Intervention 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.
- Primary Outcome Measures
Name Time Method Prevalence of Type 2 Diabetes Mellitus 18 months 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.
Prevalence of Intermediate Hyperglycemia (IHG) 18 months 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.
2-year cumulative incidence of Type 2 Diabetes Mellitus 18 months 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.
- Secondary Outcome Measures
Name Time Method Prevalence of overweight & obesity 18 months 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.
Abdominal obesity 18 months 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.Depression 18 months 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 depressionQuality of life of type II diabetes mellitis & Intermediate Hyperglycemia patients 18 months 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.
Blood pressure (BP) 18 months The study will measure and compare mean diastolic and systolic blood pressure at the Baseline and Endline via the Digital BP apparatus.
Prevalence of hypertension 18 months 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.
Body mass index (BMI) 18 months 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.Body fat composition 18 months 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
Anxiety 18 months 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
Trial Locations
- Locations (1)
Khyber Medical University Peshawar
🇵🇰Peshawar, KPK, Pakistan