The research protocol for a cluster randomised controlled trial to evaluate the effects of a community health worker led health literacy intervention on lifestyle modification among hypertensive and diabetes patients in the City of Harare, Zimbabwe (Preprint)

Hypertension and diabetes are among the most common noncommunicable diseases in Zimbabwe. These 2 conditions are largely prevented and controlled by lifestyle modifications, such as healthy eating habits, physical activity, and avoiding the use of tobacco and alcohol.This study aims to evaluate the effects of a community health worker (CHW)-led health literacy intervention on lifestyle modification among patients with diabetes and hypertension in the City of Harare, Zimbabwe, in terms of (1) adherence to recommended lifestyle changes, (2) blood pressure and blood glucose levels, and (3) medication adherence.This is a 6-month-long cluster randomized controlled trial, which will be conducted in primary health care clinics in the city of Harare. A total of 14 clinics will be randomly allocated into either the intervention or control group. A total of 680 (49 participants per clinic) adult patients with hypertension and diabetes will be enrolled for the trial. Participants in the intervention arm will receive a simple health literacy intervention on lifestyle modification, which will be delivered by trained CHWs, while those in the control arm will receive usual care. The intervention consists of 4 face-to-face interactive educational sessions and monthly support visits by trained CHWs and will be carried out over a period of 6 months. The primary study outcomes will be blood pressure and blood glucose levels and levels of adherence to the recommended lifestyle modifications. Other outcomes will include adherence to medication. Data management and analysis will be done using Epi Info software, and the data will be analyzed using the intention-to-treat principle.Recruitment of study participants commenced on June 1, 2023, and was completed on July 30, 2023. Baseline data are being collected after participants' recruitment, and the final data collection will be completed by January 31, 2024.There is an information dearth regarding the effectiveness of CHW-led interventions for the management and control of hypertension in Zimbabwe. Our study offers an opportunity to show the effectiveness of CHWs in addressing the gaps in the management of hypertension and diabetes. The findings from our study will provide crucial evidence on the effectiveness and feasibility of a simple intervention delivered by CHWs in resource-constrained areas.PRR1-10.2196/47512.