Engagement of coMmunity through Participatory learning and action for cOntrol and preVEntion of Type 2 Diabetes and its Risk factors (EMPOWER-D):protocol for a feasibility cluster randomised controlled trial in urban Pakistan

BACKGROUND: Diabetes is a rapidly growing non-communicable disease globally, with 360 million out of 537 million affected adults residing in urban centres in 2021. In Pakistan, the situation is alarming, with diabetes prevalence alone exceeding 28.3% in urban areas, placing significant strain on the healthcare system exacerbated by limited resources and high management costs. Due to these multidimensional challenges, there is a growing emphasis on large-scale community-based participatory interventions like Participatory Learning and Action (PLA) for the prevention and control of type 2 diabetes mellitus (T2DM) and to improve the health outcomes of people living with T2DM. Building on a successful rural intervention from Bangladesh (D-Magic), our study aims to adapt PLA for T2DM prevention and control in urban settings and assess its feasibility in the urban context of Pakistan. METHODS: The EMPOWER-D feasibility trial is a two-arm cluster randomised control trial (cRCT) with embedded economic and process evaluation, to be conducted in the urban setting of Karachi, Pakistan. Six clusters, defined as blocks with a population of 1500, will be randomly allocated (1:1) to intervention and control arms. The intervention arm will participate in an 18-month PLA intervention, which includes monthly community meetings where group members will identify, prioritise, and address issues related to T2DM and its associated risk factors. Recruitment, appropriateness, and intervention fidelity will be assessed, alongside anthropometric, biochemical, and sociodemographic data collection. The trial data will be descriptively reported for the feasibility outcomes. DISCUSSION: This EMPOWER-D feasibility trial is among the first to implement a culturally tailored PLA intervention to prevent and control T2DM in urban low- and middle-income countries (LMICs). By conducting a feasibility cRCT trial, we aim to generate critical insights into this approach's feasibility in an urban setting, informing the implementation of a future definitive trial. Addressing T2DM aligns with the Sustainable Development Goals for 2030, exploring how community-based research can empower LMICs to tackle local health risks and targets. TRIAL REGISTRATION: The trial is registered at Clinicaltrials.gov on 26th August 2024 [NCT06570057]. TRIAL ACRONYM: Engagement of coMmunity through Participatory learning and action for cOntrol and preVEntion of type 2 Diabetes and its Risk factors: Urban Feasibility Trial (EMPOWER-D-UFT).