E-health Interventions to Promote Physical Activity Among Inactive Adults

Study Overview
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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.

Official Title
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E-health Interventions to Promote Physical Activity Among Inactive Adults: a Hybrid Type I Effectiveness-implementation Randomized Controlled Trial

Conditions
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Physical Activity Promotion Among Inactive Adults

Intervention / Treatment
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* Device: Fitness tracker
* Other: Online training
* Other: Peer support via social media


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ftiness tracker<br>Participants in the group A will be provided the fitness tracker Mi Smart Band 5 with the computational algorithm PAI. | Device: Fitness tracker<br>* Fitness tracker Mi Smart Band 5 with the computational algorithm PAI<br>|
| Experimental: Home training platform and fitness tracker<br>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<br>* Fitness tracker Mi Smart Band 5 with the computational algorithm PAI<br>Other: Online training<br>* Les Mills On Demand<br>|
| Experimental: Peer support, home training platform and fitness tracker and<br>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<br>* Fitness tracker Mi Smart Band 5 with the computational algorithm PAI<br>Other: Online training<br>* Les Mills On Demand<br>Other: Peer support via social media<br>* Facebook group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |