Clinical trial NCT06561126: Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type II Diabetes Mellitus
Intermediate Hyperglycemia (IHG)
Keywords: Community-Based Participatory
Diabetes Mellitus
Type II Diabetes Mellitus
Intermediate hyperglycemia
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
Collaborators: name: University of York
name: Baqai Institute of Diabetology and Endocrinology
First posted: 2024-08-19
Enrollment: 12744
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Type 2 Diabetes Mellitus
timeFrame: 18 months
measure: Prevalence of Intermediate Hyperglycemia (IHG)
timeFrame: 18 months
measure: 2-year cumulative incidence of Type 2 Diabetes Mellitus
timeFrame: 18 months
Secondary outcomes:
measure: Blood pressure (BP)
timeFrame: 18 months
measure: Prevalence of hypertension
timeFrame: 18 months
measure: Abdominal obesity
timeFrame: 18 months
measure: Body mass index (BMI)
timeFrame: 18 months
measure: Prevalence of overweight & obesity
timeFrame: 18 months
measure: Depression
timeFrame: 18 months
measure: Body fat composition
timeFrame: 18 months
measure: Quality of life of type II diabetes mellitis & Intermediate Hyperglycemia patients
timeFrame: 18 months
measure: Anxiety
timeFrame: 18 months
Other outcomes:
measure: Fruit / vegetable intake
timeFrame: 18 months
measure: Hemoglobin
timeFrame: 18 months
measure: Population knowledge about diabetes
timeFrame: 18 months
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Medical University Peshawar
state: KPK
Study officials:
affiliation: Khyber Medical Univeristy Peshawar
name: Prof. Dr Zia Ul Haq, MBBS,MPH,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baqai Institute of Diabetology & Endocrinology, Karachi, Pakistan
name: Prof. Abdul Basit, MBBS,FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Khyber Medical University
name: Zohaib Khan, BDS,MPH,PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of York
name: Saima Afaq, MBBS,MPH,PHD
role: PRINCIPAL_INVESTIGATOR
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