Effectiveness of and Engagement in a Mobile Exergame With Tailored Feedback

Study Overview
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Brief Summary
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The aim of this study is to investigate the effectiveness of the 'SmartLife' intervention on reducing sedentary behavior and increasing physical activity among adolescents and to investigate the engagement in the exergame. This will be compared in three groups: an intervention group that will receive a tailored exergame; an active control condition that will receive a non-tailored exergame; and a passive control condition that receives no intervention.

Detailed Description
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The aim of this study is to investigate the effectiveness of the 'SmartLife' intervention with tailored feedback on sedentary behavior and physical activity among adolescents and to investigate the engagement in the exergame. One intervention group will receive a version of the exergame that tailors feedback. This means tailored feedback will be based on data from a sensor which is integrated in a T-shirt and paired to the game. The active control group will receive a different version of the game, that does not provide tailored feedback. Both groups will be compared to investigate their level of engagement in the game. A passive control group will be included that will be asked to continue their daily routines as usual. All three groups will be compared to determine the effectiveness of the 'SmartLife' intervention on physical activity and sedentary behavior.

Official Title
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A Clustered Randomized Controlled Trial to Compare the Effectiveness of and Engagement in a Mobile Exergame 'SmartLife' With Tailored Feedback

Conditions
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Physical Activity, Health Behavior

Intervention / Treatment
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* Behavioral: 'SmartLife' with tailored feedback
* Behavioral: 'SmartLife' without tailored feedback
* Behavioral: No game


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 12-18 years old Access to an Android smartphone (4.0.1) during study period No physical disabilities that hinder physical activity Exclusion Criteria: Not Dutch-speaking Does not have access to an Android smartphone (4.0.1)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 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
Interventional Model Description: Clustered randomized controlled trial/parallel assignment Different school classes will be allocated to one of the three groups: 1) intervention group with a game based on tailored feedback, 2) active control group with a game not using tailored feedback, 3) passive control group (waiting list group).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental with tailored feedback<br>'SmartLife' with tailored feedback: School classes will receive the developed 'SmartLife' intervention with tailored feedback, that is based on data from a sensors that is integrated in a T-shirt. | Behavioral: 'SmartLife' with tailored feedback<br>* 'SmartLife' game with tailored feedback: mobile exergame with tailored feedback. Feedback will be based on accelerometer data from a sensor that is integrated in a T-shirt. The sensor captures individually calibrated accelerometer data and is paired with the mobile exergame. Depending on the physical activity intensity of the player, the game challenge and feedback adapts individually in real-time.<br>|
| Active Comparator: Active control without tailored feedback<br>'SmartLife' without tailored feedback: School classes will receive the developed 'SmartLife' intervention without tailored feedback. | Behavioral: 'SmartLife' without tailored feedback<br>* 'SmartLife' without tailored feedback: mobile exergame without tailored feedback. The mobile exergame will not be paired to any sensor. The participant can play the mobile game, yet, will not receive any real-time feedback or adjustment in the game on physical activity intensity.<br>|
| Other: Passive control<br>School classes will not receive any intervention, thus no game. | Behavioral: No game<br>* Passive control: School classes will be asked to continue their daily life as usual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objectively measured physical activity (PA) | Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers | Baseline, 4 weeks, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objectively measured sedentary behavior (SB) | Change in amount of total sitting time, measured via accelerometers | Baseline, 4 weeks, 8 weeks | 
| Change in subjectively measured Body Mass Index (BMI) | Change in BMI, measured via self-reported weight and height | Baseline | 
| Change in determinants of PA | Change in attitude, parental support, friends' co-participation, perceived social norm, self-efficacy, perceived benefits, perceived barriers, measured by validated items (questionnaire) | Baseline, 4 weeks, 8 weeks | 
| Change in determinants of SB | Change in attitude, self-efficacy, personal norm, social norm, social support of sedentary behavior (measured for the context of 1. TV viewing, game-play, and computer use), measured by validated items (questionnaire: correlates of context specific SB, Busschaert, 2015). Items are measured on a 5-point Likert scale (strongly disagree=1 - strongly agree=5). The average for each correlate will be calculated (meaning that sub scales for one correlate (e.g. attitude) will be combined). | Baseline, 4 weeks, 8 weeks | 
| Change in behavior of PA | Change in active transportation mode to school, measured by validated items (questionnaire: Flemish physical activity questionnaire, Verstaete et al., 2003), that measures the minutes engaged in different types of transportation to school. An average score for each component (walking, cycling, active transportation, passive transportation) will be calculated. Values will be indicated by minutes per day, whereby higher values will represent a better outcome, after reversing passive transportation. | Baseline, 4 weeks, 8 weeks | 
| Differences in engagement | Differences in engagement between intervention group and active control group, measured by validated items (questionnaire: Kids Game Experience Questionnaire), that measures immersion, narrative, pos/neg. affect, flow, absorption/involvement, transportation/immersion, challenge, tension/frustration. A scale ranges from 0 to 4, whereby higher values represent a better outcome. The average scores of the subscales represent each component, and a final averaged score for the GEQ questionnaire will be calcualted. | 4 weeks | 
| Differences in basic need satisfaction | Differences in basis need satisfaction between intervention group and active cotrol group, measured via 14 validated items (questionnaire) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, sedentary behavior, serious game, exergame, behaviour change techniques, tailored feedback