An interventional study of Fitness tracker and Online training in Physical Activity Promotion Among Inactive Adults, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Prevention
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.
University Hospital of North Norway is the lead sponsor of 150 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the group A will be provided the fitness tracker Mi Smart Band 5 with the computational algorithm PAI.
Device: 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.
Device: Fitness tracker · Other: Online training
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 tracker · Other: Online training · Other: Peer support via social media
Fitness tracker Mi Smart Band 5 with the computational algorithm PAI
Les Mills On Demand
Facebook group
Level of physical activity short-term
Time spent in moderate to vigorous physical activity
Time frame: 6 months
Level of physical activity medium-term
Time spent in moderate to vigorous physical activity
Time frame: 12 months
Level of physical activity long-term
Time spent in moderate to vigorous physical activity
Time frame: 18 months
Adherence to recommendation short-term
Proportion of participants reaching the recommendation for physical activity
Time frame: 6 months
Adherence to recommendation medium-term
Proportion of participants reaching the recommendation for physical activity
Time frame: 12 months
Adherence to recommendation long-term
Proportion of participants reaching the recommendation for physical activity
Time frame: 18 months
Physical fitness short-term
VO2 max (estimated)
Time frame: 6 months
Physical fitness medium-term
VO2 max (estimated)
Time frame: 12 months
Physical fitness long-term
VO2 max (estimated)
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 18 months
Perceived competence for exercise (PCS-EX) short-term
4 items. Min 4, max 28 (28 high competence)
Time frame: 6 months
Perceived competence for exercise (PCS-EX) medium-term
4 items. Min 4, max 28 (28 high competence)
Time frame: 12 months
Perceived competence for exercise (PCS-EX) long-term
4 items. Min 4, max 28 (28 high competence)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 18 months
Reasons for performing physical activity short-term
Behavioural Regulation Exercise Questionnaire (BREQ-2).
Time frame: 6 months
Reasons for performing physical activity medium-term
Behavioural Regulation Exercise Questionnaire (BREQ-2).
Time frame: 12 months
Reasons for performing physical activity long-term
Behavioural Regulation Exercise Questionnaire (BREQ-2).
Time frame: 18 months
System Usability Scale (SUS)
10 items, min 0 max 100 (above 68 is above the average).
Time frame: 6 months
Users' perspectives on intervention through interviews short-term
Qualitative data derived from semi-structured interviews with participants.
Time frame: 6 months
Users' perspectives on intervention through interviews long-term
Qualitative data derived from semi-structured interviews with participants.
Time frame: 18 months
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Hospital of North Norway