E-health Interventions to Promote Physical Activity Among Inactive Adults

NCT ID: NCT04526444

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-08

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Physical Activity Promotion Among Inactive Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ftiness tracker

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

Group Type EXPERIMENTAL

Fitness tracker

Intervention Type DEVICE

Fitness tracker Mi Smart Band 5 with the computational algorithm PAI

Home training platform and fitness tracker

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.

Group Type EXPERIMENTAL

Fitness tracker

Intervention Type DEVICE

Fitness tracker Mi Smart Band 5 with the computational algorithm PAI

Online training

Intervention Type OTHER

Les Mills On Demand

Peer support, home training platform and fitness tracker and

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.

Group Type EXPERIMENTAL

Fitness tracker

Intervention Type DEVICE

Fitness tracker Mi Smart Band 5 with the computational algorithm PAI

Online training

Intervention Type OTHER

Les Mills On Demand

Peer support via social media

Intervention Type OTHER

Facebook group

Interventions

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Fitness tracker

Fitness tracker Mi Smart Band 5 with the computational algorithm PAI

Intervention Type DEVICE

Online training

Les Mills On Demand

Intervention Type OTHER

Peer support via social media

Facebook group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UiT The Arctic University of Norway

OTHER

Sponsor Role collaborator

SINTEF Health Research

OTHER

Sponsor Role collaborator

PAI Health Norway AS

UNKNOWN

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

Frisklivssentralen

UNKNOWN

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role collaborator

Les Mills International

UNKNOWN

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Paolo Zanaboni

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Norwegian Centre for E-health Research

Tromsø, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 40546750 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38239801 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36339169 (View on PubMed)

Other Identifiers

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66573

Identifier Type: -

Identifier Source: org_study_id

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