Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 5, 2024
Date Accepted: Jun 3, 2025
Effectiveness of mHealth program on blood pressure among prehypertensive young adults: Protocol of a Pragmatic Cluster Randomized Controlled Trial
ABSTRACT
Background:
The prevalence of prehypertension may be underreported because of its asymptomatic nature. The study will use a pragmatic mHealth application for delivering the intervention, which is expected to be well-received by the young population.
Objective:
The study aims to assess the prevalence of prehypertension among young adults and evaluate the effectiveness of a mHealth intervention in enhancing adherence to lifestyle practices, knowledge on prehypertension and hypertension, and blood pressure among participants in the experimental and control groups.
Methods:
The study will be conducted in two phases. Phase I will employ a cross-sectional survey design, and Phase II will include a pragmatic randomized controlled trial with cluster randomization.The protocol was prepared according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 checklist. The CONSORT 2017 guideline was followed in reporting the protocol. The estimated sample size for Phase I is 762, and the sample size for the Phase II is 85 per group. Both the control and experimental groups will receive education on prehypertension and hypertension, with the experimental group additionally receiving a mHealth app. The experimental group’s adherence to lifestyle practices will be monitored every 15 days, and reminder messages will be sent to non-responders. Both groups will be followed up onsite at 1, 3, and 6 months to assess their knowledge on prehypertension and hypertension, blood pressure, and lifestyle practices.
Results:
The primary outcome of the study will be an improvement in blood pressure readings. The secondary outcomes will include adherence to lifestyle practices and knowledge on prehypertension and hypertension. The study is ongoing, and as of July 2024, Phase I is completed with the data collected from 762 sample from 8 randomly selected colleges from Udupi district. Currently, phase 2 is in process. The data will be analyzed using Jamovi 2.3.21.
Conclusions:
Identifying high-risk groups of young adults with prehypertension enables early interventions to prevent future hypertension and related organ damage. The study will contribute to achieving Sustainable Development Goal 3, which focuses on ensuring good health and well-being. Clinical Trial: CTRI/2023/04/051784
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