Scaling Up Community-based Noncommunicable Disease Research into Practice in Pokhara Metropolitan City of Nepal (SCALE-NCD) trial: study protocol for a cluster-randomized controlled trial.

Background: Rapid globalization and urbanization continue to escalate the burden of non-communicable diseases (NCDs) across the world, disproportionally affecting low- and middle-income countries (LMICs). To date, trials have documented that task-sharing with community health workers (CHWs) can reduce systolic blood pressure (SBP), reduce fasting blood glucose, and achieve smoking cessation. However, most studies have been conducted in rural settings, or focused on managing a single condition, such as hypertension only. Methods: We propose an open-label, two-armed, community-based cluster randomized controlled trial in Pokhara Metropolitan City of Nepal; the second largest city in Nepal. A total of 30 clusters will be randomized into intervention or control arm in a 1:1 ratio. An individual is eligible if living in Pokhara Metropolitan City and having one or more of the following conditions: hypertension, type 2 diabetes, and tobacco smoking. The participants will be recruited through study team home visits. The intervention group will receive an intervention package "SCALE-NCD" which includes 1) home-based monitoring, referral, and counseling for self-management of hypertension, diabetes and tobacco smoking by Female Community Health Volunteers (FCHVs), and 2) weekly mobile phone messages to promote healthy lifestyle. FCHVs are CHWs in Nepal whose usual tasks are limited to maternal and child health care services. The control group will receive usual care, where there is neither of aforementioned two components. Primary outcomes are change in SBP, change in fasting plasma glucose, and change in smoking cessation, the required sample size for which is 405, 105, and 525 per arm, respectively. Discussion: This study will inform us of the effectiveness of a FCHV-led, and home-based management of the top three NCD risk factors coupled with weekly mobile phone messages in urban Nepal. Building on the previous studies that measured the efficacy of FCHV-led home-based management of a single NCD risk factor in a small geographical area, this scaled-up study will provide us with the realistic impact that FCHVs may have if they are trained to provide primary care services for management of major NCD risk factors. Trial registration: ClinicalTrials.gov NCT06740708. Registered on 2024-12-13.