Digital interventions to promote physical activity among inactive adults: A study protocol for a hybrid type I effectiveness-implementation randomized controlled trial

Paolo Zanaboni, Unn Sollid Manskow, Edvard Hamnvik Sagelv, Bente Morseth, Alf Egil Edvardsen, Inger-Lise Aamot, Bjarne Martens Nes, Bryce Hastings, Marie-Pierre Gagnon, Konstantinos Antypas, Paolo Zanaboni, Unn Sollid Manskow, Edvard Hamnvik Sagelv, Bente Morseth, Alf Egil Edvardsen, Inger-Lise Aamot, Bjarne Martens Nes, Bryce Hastings, Marie-Pierre Gagnon, Konstantinos Antypas

Abstract

Introduction: Physical inactivity is the fourth leading risk factor for global mortality, and inactive adults have a higher risk to develop lifestyle diseases. To date, there is preliminary evidence of the efficacy of fitness technologies and other digital interventions for physical activity (PA) promotion. Intervention studies are needed to test the effectiveness and implementation of innovative PA promotion strategies.

Methods and analysis: The ONWARDS study is a hybrid type I effectiveness-implementation randomized control trial aiming at an inactive and presumably high-risk population living in Northern Norway. One hundred and eighty participants will be assigned to 3 groups in a 1:1:1 ratio and participate for 18 months. Participants in group A will be provided an activity tracker with the personalized metric Personal Activity Intelligence (PAI). Participants in group B will be provided with both an activity tracker with the personalized metric PAI and access to online training videos (Les Mills+) to perform home-based training. Participants in group C will be provided an activity tracker with the personalized metric PAI, home-based online training and additional peer support via social media. The primary objective is to test which combination of interventions is more effective in increasing PA levels and sustaining long-term exercise adherence. Secondary objectives include: proportion of participants reaching PA recommendations; exercise adherence; physical fitness; cardiovascular risk; quality of life; perceived competence for exercise; self-efficacy; social support; usability; users' perspectives on implementation outcomes (adoption, acceptability, adherence, sustainability). The study design will allow testing the effectiveness of the interventions while gathering information on implementation in a real-world situation.

Discussion: This study can contribute to reduce disparities in PA levels among inactive adults by promoting PA and long-term adherence. Increased PA might, in turn, result in better prevention of lifestyle diseases. Digital interventions delivered at home can become an alternative to training facilities, making PA accessible and feasible for inactive populations and overcoming known barriers to PA. If effective, such interventions could potentially be offered through national health portals to citizens who do not meet the minimum recommendations on PA or prescribed by general practitioners or specialists.

Trial registration: https://ichgcp.net/clinical-trials-registry/NCT04526444, Registered 23 April 2021, identifier: NCT04526444.

Keywords: digital interventions; e-health; lifestyle diseases; mobile health; physical activity; randomized controlled trial.

Conflict of interest statement

Author AEE was employed by Memento U. Author BH is Head of Research at Les Mills International. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Zanaboni, Manskow, Sagelv, Morseth, Edvardsen, Aamot, Nes, Hastings, Gagnon and Antypas.

Figures

Figure 1
Figure 1
Interventions provided to the three groups.
Figure 2
Figure 2
Flow of study participants.

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