Clinical trial NCT06570057: Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors
Official title: Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]: Feasibility Trial in Urban Pakistan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type II Diabetes Mellitus
Keywords: Community-Based Participatory Research
Participatory Learning and Action Research
Type II Diabetes Mellitus
Intermediate hyperglycemia
Lead sponsor: Baqai Institute of Diabetology and Endocrinology
Sponsor class: OTHER
Collaborators: name: University of York
name: Khyber Medical University Peshawar
name: HealthNet TPO
name: National Institute for Health Research, United Kingdom
name: Aga Khan University Hospital, Pakistan
First posted: 2024-08-26
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel study design would be used. Six clusters will be randomly selected from purely urban blocks of Karachi. The study sites will be selected in a manner that the risk of possible contamination between control and intervention groups is avoided. The intervention clusters will receive the 18-months long PLA intervention along with study assessments, while the control clusters will only go through assessments i.e., at baseline and end of study. A referral mechanism will be followed for both intervention and control arm, which will ensure that the individuals with newly diagnosed diabetes will be referred to the nearest diabetes care facility.
Primary purpose: PREVENTION

Brief summary: This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.

Detailed description: The pivotal components of this approach include adapting, implementing, and evaluating the Participatory Learning and Action (PLA) based intervention for the prevention and control of Type II diabetes (TIIDM). 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). Around 80% of people with TIIDM reside in low-and middle-income countries (LMICs), exhausting the already burdened healthcare system.

The intervention, adapted from the "Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in Bangladesh (DMagic)" trial, has been tested and found effective in the rural context of Bangladesh. However, PLA-based intervention has not been previously tested in urban communities. Considering the distinct sociocultural environment of urban settings, a feasibility trial will be conducted in urban Karachi, Pakistan.

The feasibility trial will assess the intervention's adaptability and effectiveness in this new context. It is anticipated that the use of evidence-based approaches, best practices, and meaningful community participation through PLA will enhance the social and behavioral determinants of health and lead to improved health outcomes. This approach aims to control TIIDM and pave the way for managing other non-communicable diseases through similar focused interventions.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 20 years and above.
* Participants residing in the randomized clusters of Karachi, 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 non-compliance with research protocols

Primary outcomes:
measure: Prevalence of Type II Diabetes Mellitus
timeFrame: 18 months
measure: Two-year cumulative incidence of Type II Diabetes Mellitus
timeFrame: 18 months
Secondary outcomes:
measure: Mean diastolic and systolic blood pressure
timeFrame: 18 months
measure: Prevalence of hypertension
timeFrame: 18 months
measure: Abdominal obesity
timeFrame: 18 months
measure: Mean body mass index
timeFrame: 18 months
measure: Health-related quality of life
timeFrame: 18 months
measure: Frequency of depression
timeFrame: 18 months
measure: Mean body fat percentage
timeFrame: 18 months
measure: Prevalence of overweight and obesity
timeFrame: 18 months
measure: Frequency of anxiety
timeFrame: 18 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Baqai Institute of Diabetology and Endocrinology (BIDE)
state: Sindh
Study officials:
affiliation: Baqai Institute of Diabetes and Endocrinology
name: Abdul Basit, Director
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imtiaz S, Afaq S, Jennings HM, Tahir A, Sanauddin N, Khaleeq N, et al. Community Health Participatory (CHP) Interventions in the Prevention and Control of Non-communicable Diseases in conflict-affected LMICs- A Scoping Review Protocol [Internet]. OSF; 2024.