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| Name | Class |
|---|---|
| UiT The Arctic University of Norway | OTHER |
| SINTEF Health Research | OTHER |
| PAI Health Norway AS | UNKNOWN |
| St. Olavs Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ftiness tracker | Experimental | Participants in the group A will be provided the fitness tracker Mi Smart Band 5 with the computational algorithm PAI. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitness tracker | Device | Fitness tracker Mi Smart Band 5 with the computational algorithm PAI |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to recommendation short-term | Proportion of participants reaching the recommendation for physical activity | 6 months |
| Adherence to recommendation medium-term | Proportion of participants reaching the recommendation for physical activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian Centre for E-health Research | Tromsø | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40546750 | Derived | 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. | |
| 38239801 |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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| OTHER |
| Norwegian University of Science and Technology | OTHER |
| Frisklivssentralen | UNKNOWN |
| Laval University | OTHER |
| Les Mills International | INDUSTRY |
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| Online training | Other | Les Mills On Demand |
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| Peer support via social media | Other | Facebook group |
|
| 12 months |
| Adherence to recommendation long-term | Proportion of participants reaching the recommendation for physical activity | 18 months |
| Physical fitness short-term | VO2 max (estimated) | 6 months |
| Physical fitness medium-term | VO2 max (estimated) | 12 months |
| Physical fitness long-term | VO2 max (estimated) | 18 months |
| Body Mass Index (BMI) short-term | 6 months |
| Body Mass Index (BMI) medium-term | 12 months |
| Body Mass Index (BMI) long-term | 18 months |
| Waist circumference short-term | 6 months |
| Waist circumference medium-term | 12 months |
| Waist circumference long-term | 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). | 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). | 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). | 18 months |
| Perceived competence for exercise (PCS-EX) short-term | 4 items. Min 4, max 28 (28 high competence) | 6 months |
| Perceived competence for exercise (PCS-EX) medium-term | 4 items. Min 4, max 28 (28 high competence) | 12 months |
| Perceived competence for exercise (PCS-EX) long-term | 4 items. Min 4, max 28 (28 high competence) | 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. | 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. | 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. | 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) | 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) | 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) | 18 months |
| Reasons for performing physical activity short-term | Behavioural Regulation Exercise Questionnaire (BREQ-2). | 6 months |
| Reasons for performing physical activity medium-term | Behavioural Regulation Exercise Questionnaire (BREQ-2). | 12 months |
| Reasons for performing physical activity long-term | Behavioural Regulation Exercise Questionnaire (BREQ-2). | 18 months |
| System Usability Scale (SUS) | 10 items, min 0 max 100 (above 68 is above the average). | 6 months |
| Users' perspectives on intervention through interviews short-term | Qualitative data derived from semi-structured interviews with participants. | 6 months |
| Users' perspectives on intervention through interviews long-term | Qualitative data derived from semi-structured interviews with participants. | 18 months |
| 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. |
| 36339169 | Derived | 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. |