NCT04526444

Brief Summary

The project addresses physical inactivity as a global health issue. Physical inactivity is the fourth leading risk factor for global mortality. Moreover, inactive adults have a higher risk to develop lifestyle diseases. To date, there is preliminary evidence of the efficacy in the use of certain strategies including fitness technologies and digital interventions for physical activity (PA) promotion. Intervention studies are needed to test the effectiveness of PA promotion strategies. A Hybrid Type I effectiveness-implementation randomised controlled trial (RCT) will investigate the effects of 1) fitness trackers, 2) home-based online training, and 3) peer support via social media among inactive adults. The design will allow testing the study outcomes while gathering information on implementation in a real-world situation. The study will produce evidence on whether these interventions increase the levels of PA among inactive adults and improve health outcomes. Increased PA will also result in better primary prevention of lifestyle diseases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

April 8, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

August 7, 2020

Last Update Submit

May 10, 2023

Conditions

Physical Activity Promotion Among Inactive Adults

Outcome Measures

Primary Outcomes (3)

  • Level of physical activity short-term

    Time spent in moderate to vigorous physical activity

    6 months

  • Level of physical activity medium-term

    Time spent in moderate to vigorous physical activity

    12 months

  • Level of physical activity long-term

    Time spent in moderate to vigorous physical activity

    18 months

Secondary Outcomes (30)

  • Adherence to recommendation short-term

    6 months

  • Adherence to recommendation medium-term

    12 months

  • Adherence to recommendation long-term

    18 months

  • Physical fitness short-term

    6 months

  • Physical fitness medium-term

    12 months

  • +25 more secondary outcomes

Study Arms (3)

Ftiness tracker

EXPERIMENTAL

Participants in the group A will be provided the fitness tracker Mi Smart Band 5 with the computational algorithm PAI.

Device: Fitness tracker

Home training platform and fitness tracker

EXPERIMENTAL

Participants in group B will be provided with both the fitness tracker Mi Smart Band 5 with the computational algorithm PAI and access to Les Mills On Demand to perform training classes from home.

Device: Fitness trackerOther: Online training

Peer support, home training platform and fitness tracker and

EXPERIMENTAL

Participants in group C will be offered the fitness tracker Mi Smart Band 5 with the computational algorithm PAI, Les Mills On Demand and additional peer support via social media.

Device: Fitness trackerOther: Online trainingOther: Peer support via social media

Interventions

Fitness trackerDEVICE

Fitness tracker Mi Smart Band 5 with the computational algorithm PAI

Ftiness trackerHome training platform and fitness trackerPeer support, home training platform and fitness tracker and
Online trainingOTHER

Les Mills On Demand

Home training platform and fitness trackerPeer support, home training platform and fitness tracker and
Peer support via social mediaOTHER

Facebook group

Peer support, home training platform and fitness tracker and

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • young (18-40 years) or middle aged (40-55 years) healthy adults, both men and women;
  • inactive (undertaking less than 150 min of moderate-intensity PA per week) in the last 3 months;
  • living in the Troms and Finnmark county;
  • current owner of a smartphone;
  • able to understand training instructions in English language.

You may not qualify if:

  • presence of disabilities which might reduce the ability to perform exercise;
  • presence of conditions which might prevent from safely exercise;
  • lack of Internet connection at home;
  • lack of space to exercise safely at home (recommended 4 sqm).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Centre for E-health Research

Tromsø, Norway

Location

Related Publications (3)

  • Sagelv EH, Manskow US, Antypas K, Morseth B, Aamot Aksetoy IL, Nes BM, Gagnon MP, Zanaboni P. Online interventions to increase physical activity levels in self-reported inactive adults: the ONWARDS randomised controlled trial. BMJ Open Sport Exerc Med. 2025 Jun 16;11(2):e001816. doi: 10.1136/bmjsem-2023-001816. eCollection 2025.

    PMID: 40546750DERIVED

  • Manskow US, Sagelv EH, Antypas K, Zanaboni P. Adoption, acceptability and sustained use of digital interventions to promote physical activity among inactive adults: a mixed-method study. Front Public Health. 2024 Jan 4;11:1297844. doi: 10.3389/fpubh.2023.1297844. eCollection 2023.

    PMID: 38239801DERIVED

  • Zanaboni P, Manskow US, Sagelv EH, Morseth B, Edvardsen AE, Aamot IL, Nes BM, Hastings B, Gagnon MP, Antypas K. Digital interventions to promote physical activity among inactive adults: A study protocol for a hybrid type I effectiveness-implementation randomized controlled trial. Front Public Health. 2022 Oct 21;10:925484. doi: 10.3389/fpubh.2022.925484. eCollection 2022.

    PMID: 36339169DERIVED

MeSH Terms

Interventions

Fitness Trackers

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 25, 2020

Study Start

April 8, 2021

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)