Alnes, Sigrid Ryeng
Laerum-Onsager, Ellisiv
Bye, Asta
Vistven, Annette
Franzén, Erika
Holst, Mette
Brovold, Therese
Funding for this research was provided by:
OsloMet - Oslo Metropolitan University
Article History
Received: 24 July 2025
Accepted: 10 February 2026
First Online: 17 February 2026
Declarations
:
: The project received approval from the Regional Committee for Medical Research Ethics South/East Norway (REK South/East) (REC116419) and was registered at clinicalTrials.gov (NCT04945876). The study adhered to the Declaration of Helsinki, Good Clinical Practice guidelines, and the SPIRIT reporting guidelines. All participants provided written consent (improved by the REK South/East) prior to enrolment. Participation was voluntary, and participants were informed of their right to withdraw consent at any time. Data were pseudonymised using unique ID numbers and securely stored on the Services for Sensitive Data (TSD) platform. Participants received no financial compensation except for reimbursement of travel expenses. Potential adverse events could be reported at follow-up testing, and, for the mHealth group, during monthly consultation. No study related adverse events were reported or observed during study. To address differential treatment between groups, all participants in the usual-care group was offered a session on PA and dietary guidance following their final follow-up test, as well as information on how the activity tracker was utilised, with the option to test the device if interested.
: Not applicable.
: The authors declare no competing interests.