CLINICAL TRIAL article
Front. Digit. Health
Sec. Connected Health
Volume 7 - 2025 | doi: 10.3389/fdgth.2025.1672553
App-Based Multimodal Lifestyle-Intervention for Essential Hypertension (HYPE): A Decentralized Randomised Controlled Trial
Provisionally accepted
- 1Hannover Medical School, Hanover, Germany
- 2Oviva AG, Potsdam, Germany
- 3Oviva UK Limited, London, United Kingdom
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Background Life-style interventions are effective in lowering blood pressure (BP) and reducing cardiovascular risk, but implementation is poor. We aimed to evaluate the efficacy of an app-based multimodal lifestyle intervention in reducing BP in patients with uncontrolled hypertension. Methods In a decentralized, single-blinded, randomized-controlled trial, adults with uncontrolled hypertension by home BP measurement were randomized to 12 weeks of app-based multimodal lifestyle intervention or care as usual. The primary outcome was the difference of mean systolic BP after 12 weeks. Secondary outcomes were mean diastolic BP difference, and changes in body weight, health-related quality of life, and food literacy. An intention-to-treat analysis with multiple imputation by chained equations (MICE) was performed. Results From June 13, 2024, to September 30, 2024, a total of 139 pts. were randomized with a mean baseline BP of 142/88 mmHg, of which 55% were females. After 12 weeks, there was a significantly lower systolic BP in the intervention group (-8.5 mmHg, [95% CI: -11.0 - -5.9], p < 0.001). At this time point, the intervention group also showed significantly lower diastolic BP (-5.06 mmHg), a larger relative reduction in body weight (-2.88 %) as well as larger improvements in health-related quality of life and food literacy. Responder analysis confirmed that the effects were large and consistent across outcomes. No serious adverse events related to the intervention occurred during the trial. Conclusion A digital multimodal lifestyle intervention may clinically improve general hypertension care and should be evaluated in larger trials. German Clinical Trials Register (DRKS00034348)
Keywords: Hypertension, lifestyle-intervention, digital therapeutics, randomised-controlledtrial, APP
Received: 24 Jul 2025; Accepted: 29 Sep 2025.
Copyright: © 2025 Beger, Lehmann, Kaup, Jones, Mijuskovic and Limbourg. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Florian P Limbourg, limbourg.florian@mh-hannover.de
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.