Physical Activity Promotion Among Inactive AdultsONWARDSNCT04526444
E-health Interventions to Promote Physical Activity Among Inactive Adults
A study testing Fitness tracker, Online training and Peer support via social media in people with Physical Activity Promotion Among Inactive Adults, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity Promotion Among Inactive Adults
- What is being tested?
- Fitness tracker, Online training and Peer support via social media
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteNorway
- Study dates
- 8 Apr 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E-health Interventions to Promote Physical Activity Among Inactive Adults: a Hybrid Type I Effectiveness-implementation Randomized Controlled Trial
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.
- Being tested
- Fitness tracker, Online training, Peer support via social media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness trackerDevice
Fitness tracker Mi Smart Band 5 with the computational algorithm PAI
Online trainingOther
Les Mills On Demand
Peer support via social mediaOther
Facebook group
| Study group | Role | What they receive |
|---|---|---|
| Ftiness tracker | Experimental | Participants in the group A will be provided the fitness tracker Mi Smart Band 5 with the computational algorithm PAI. Receives: 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. Receives: Device: Fitness tracker; Other: 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. Receives: Device: Fitness tracker; Other: Online training; Other: Peer support via social media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of physical activity short-term
Time spent in moderate to vigorous physical activity
Measured: 6 months
Level of physical activity medium-term
Time spent in moderate to vigorous physical activity
Measured: 12 months
Level of physical activity long-term
Time spent in moderate to vigorous physical activity
Measured: 18 months
Secondary outcomes (30)
Adherence to recommendation short-term
Proportion of participants reaching the recommendation for physical activity
Measured: 6 months
Adherence to recommendation medium-term
Proportion of participants reaching the recommendation for physical activity
Measured: 12 months
Adherence to recommendation long-term
Proportion of participants reaching the recommendation for physical activity
Measured: 18 months
Physical fitness short-term
VO2 max (estimated)
Measured: 6 months
Physical fitness medium-term
VO2 max (estimated)
Measured: 12 months
Physical fitness long-term
VO2 max (estimated)
Measured: 18 months
Body Mass Index (BMI) short-term
Measured: 6 months
Body Mass Index (BMI) medium-term
Measured: 12 months
Body Mass Index (BMI) long-term
Measured: 18 months
Waist circumference short-term
Measured: 6 months
Waist circumference medium-term
Measured: 12 months
Waist circumference long-term
Measured: 18 months
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life short-term
EQ-5D-5L has 5 dimensions and 5 levels from 1 to 5 in each dimension (1 is no problems). It also includes a Visual Analogue scale from 0 to 100 (100 is best possible health). Rating can be transformed to a score with min -0.654 and max (1 is no problems in all dimensions).
Measured: 6 months
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life medium-term
EQ-5D-5L has 5 dimensions and 5 levels from 1 to 5 in each dimension (1 is no problems). It also includes a Visual Analogue scale from 0 to 100 (100 is best possible health). Rating can be transformed to a score with min -0.654 and max (1 is no problems in all dimensions).
Measured: 12 months
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life long-term
EQ-5D-5L has 5 dimensions and 5 levels from 1 to 5 in each dimension (1 is no problems). It also includes a Visual Analogue scale from 0 to 100 (100 is best possible health). Rating can be transformed to a score with min -0.654 and max (1 is no problems in all dimensions).
Measured: 18 months
Perceived competence for exercise (PCS-EX) short-term
4 items. Min 4, max 28 (28 high competence)
Measured: 6 months
Perceived competence for exercise (PCS-EX) medium-term
4 items. Min 4, max 28 (28 high competence)
Measured: 12 months
Perceived competence for exercise (PCS-EX) long-term
4 items. Min 4, max 28 (28 high competence)
Measured: 18 months
Self-efficacy for exercise (SEE) Scale short-term
Scale with 9 items, min 0 and max 90. Higher score indicates higher self-efficacy for exercise.
Measured: 6 months
Self-efficacy for exercise (SEE) Scale medium-term
Scale with 9 items, min 0 and max 90. Higher score indicates higher self-efficacy for exercise.
Measured: 12 months
Self-efficacy for exercise (SEE) Scale long-term
Scale with 9 items, min 0 and max 90. Higher score indicates higher self-efficacy for exercise.
Measured: 18 months
Social Support (SSES) short-term
13 items answered two times, one for family and one for friends. Min 13, max 65 (65 highest level of social support)
Measured: 6 months
Social Support (SSES) medium-term
13 items answered two times, one for family and one for friends. Min 13, max 65 (65 highest level of social support)
Measured: 12 months
Social Support and Exercise scale (SSES) long-term
13 items answered two times, one for family and one for friends. Min 13, max 65 (65 highest level of social support)
Measured: 18 months
Reasons for performing physical activity short-term
Behavioural Regulation Exercise Questionnaire (BREQ-2).
Measured: 6 months
Reasons for performing physical activity medium-term
Behavioural Regulation Exercise Questionnaire (BREQ-2).
Measured: 12 months
Reasons for performing physical activity long-term
Behavioural Regulation Exercise Questionnaire (BREQ-2).
Measured: 18 months
System Usability Scale (SUS)
10 items, min 0 max 100 (above 68 is above the average).
Measured: 6 months
Users' perspectives on intervention through interviews short-term
Qualitative data derived from semi-structured interviews with participants.
Measured: 6 months
Users' perspectives on intervention through interviews long-term
Qualitative data derived from semi-structured interviews with participants.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start8 Apr 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical Activity Promotion Among Inactive AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- UiT The Arctic University of Norway, SINTEF Health Research, PAI Health Norway AS, St. Olavs Hospital, Norwegian University of Science and Technology, Frisklivssentralen, Laval University, Les Mills International
- Responsible party
- Principal investigator, Paolo Zanaboni, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526444
- Sponsor's protocol ID
- 66573
- Acronym
- ONWARDS
- Status last verified
- May 2023
- First submitted
- 7 Aug 2020
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40546750Manskow 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.
PubMed 38239801Zanaboni 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.
PubMed 36339169
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-health Interventions to Promote Physical Activity Among Inactive Adults: a Hybrid Type I Effectiveness-implementation Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04526444
- Acronym / sponsor ID
- ONWARDS / 66573
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- UiT The Arctic University of Norway, SINTEF Health Research, PAI Health Norway AS, St. Olavs Hospital, Norwegian University of Science and Technology, Frisklivssentralen, Laval University, Les Mills International
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ftiness tracker | Experimental | Device: Fitness trackerParticipants in the group A will be provided the fitness tracker Mi Smart Band 5 with the computational algorithm PAI. |
| Home training platform and fitness tracker | Experimental | Device: Fitness tracker, Other: Online trainingParticipants 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. |
| Peer support, home training platform and fitness tracker and | Experimental | Device: Fitness tracker, Other: Online training, Other: Peer support via social mediaParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitness trackerFitness tracker Mi Smart Band 5 with the computational algorithm PAI | Device | Ftiness tracker, Home training platform and fitness tracker, Peer support, home training platform and fitness tracker and |
| Online trainingLes Mills On Demand | Other | Home training platform and fitness tracker, Peer support, home training platform and fitness tracker and |
| Peer support via social mediaFacebook group | Other | Peer support, home training platform and fitness tracker and |
Primary outcome
Level of physical activity short-term
Time frame: 6 months
Time spent in moderate to vigorous physical activity
Level of physical activity medium-term
Time frame: 12 months
Time spent in moderate to vigorous physical activity
Level of physical activity long-term
Time frame: 18 months
Time spent in moderate to vigorous physical activity
30 secondary outcomes
Adherence to recommendation short-term
Time frame: 6 months
Adherence to recommendation medium-term
Time frame: 12 months
Adherence to recommendation long-term
Time frame: 18 months
Physical fitness short-term
Time frame: 6 months
Physical fitness medium-term
Time frame: 12 months
Physical fitness long-term
Time frame: 18 months
Body Mass Index (BMI) short-term
Time frame: 6 months
Body Mass Index (BMI) medium-term
Time frame: 12 months
Body Mass Index (BMI) long-term
Time frame: 18 months
Waist circumference short-term
Time frame: 6 months
Waist circumference medium-term
Time frame: 12 months
Waist circumference long-term
Time frame: 18 months
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life short-term
Time frame: 6 months
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life medium-term
Time frame: 12 months
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life long-term
Time frame: 18 months
Perceived competence for exercise (PCS-EX) short-term
Time frame: 6 months
Perceived competence for exercise (PCS-EX) medium-term
Time frame: 12 months
Perceived competence for exercise (PCS-EX) long-term
Time frame: 18 months
Self-efficacy for exercise (SEE) Scale short-term
Time frame: 6 months
Self-efficacy for exercise (SEE) Scale medium-term
Time frame: 12 months
Self-efficacy for exercise (SEE) Scale long-term
Time frame: 18 months
Social Support (SSES) short-term
Time frame: 6 months
Social Support (SSES) medium-term
Time frame: 12 months
Social Support and Exercise scale (SSES) long-term
Time frame: 18 months
Reasons for performing physical activity short-term
Time frame: 6 months
Reasons for performing physical activity medium-term
Time frame: 12 months
Reasons for performing physical activity long-term
Time frame: 18 months
System Usability Scale (SUS)
Time frame: 6 months
Users' perspectives on intervention through interviews short-term
Time frame: 6 months
Users' perspectives on intervention through interviews long-term
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 40546750Sagelv 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.
- Derived from this study: PubMed 38239801Manskow 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.
- Derived from this study: PubMed 36339169Zanaboni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness tracker, Online training and Peer support via social media in people with Physical Activity Promotion Among Inactive Adults, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of physical activity short-term (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04526444, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.