Effectiveness of an mHealth Program on Reducing Blood Pressure Among Young Adults With Prehypertension: Protocol of a Pragmatic Cluster Randomized Controlled Trial.

BACKGROUND

The prevalence of prehypertension may be underreported because of its asymptomatic nature. This study will use a pragmatic mobile health (mHealth) app to deliver the intervention, which is expected to be well received by the young adult population.

OBJECTIVE

This study aims to assess the prevalence of prehypertension among young adults and evaluate the effectiveness of an mHealth intervention in enhancing adherence to lifestyle practices, increasing knowledge on prehypertension and hypertension, and reducing blood pressure among participants in the experimental and control groups.

METHODS

The study consists of 2 phases. Phase 1 used a cross-sectional survey design, and phase 2 included 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 (Consolidated Standards of Reporting Trials of Nonpharmacologic Interventions) 2017 guideline was followed for reporting the protocol. The estimated sample size for phase 1 was 762 participants, and the sample size for the phase 2 was 85 participants per group. Both the control and experimental groups will receive education on prehypertension and hypertension, with the experimental group additionally receiving an mHealth app. The experimental group's adherence to lifestyle practices will be monitored every 15 days, and reminder messages will be sent to nonresponders. Both groups will be followed up with on-site after 1, 3, and 6 months to assess their knowledge on prehypertension and hypertension, blood pressure, and lifestyle practices. 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.

RESULTS

This study was funded by the Indian Council of Medical Research (grant 2021-11792, received February 2023). The study is ongoing. Phase 1 was completed on March 29, 2024, with data collected from 762 samples from 8 randomly selected colleges from Udupi District. Currently, phase 2 is in progress. The data will be analyzed using jamovi software (version 2.3.21; The jamovi project). Phase 1 and 2 findings will be analyzed and the results will be published in a peer-reviewed journal. Ethical approval for the study was obtained in May 2022 (160/2022).

CONCLUSIONS

Identifying high-risk groups of young adults with prehypertension enables early interventions to prevent future hypertension and combat the cardiovascular burden globally. The mHealth intervention is considered to be an effective strategy to impart knowledge and promote healthy behaviors among young adults. The study will contribute to achieving the United Nation's Sustainable Development Goal 3, which focuses on ensuring good health and well-being.

TRIAL REGISTRATION

Clinical Trial Registry of India CTRI/2023/04/051784; https://tinyurl.com/57y9enyd.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67216.