Clinical trial NCT03659604: Effectiveness of and Engagement in a Mobile Exergame With Tailored Feedback
Official title: A Clustered Randomized Controlled Trial to Compare the Effectiveness of and Engagement in a Mobile Exergame 'SmartLife' With Tailored Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Health Behavior
Keywords: physical activity
sedentary behavior
serious game
exergame
behaviour change techniques
tailored feedback
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2018-09-06
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in objectively measured physical activity (PA)
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Change in objectively measured sedentary behavior (SB)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in subjectively measured Body Mass Index (BMI)
timeFrame: Baseline
measure: Change in determinants of PA
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in determinants of SB
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in behavior of PA
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Differences in engagement
timeFrame: 4 weeks
measure: Differences in basic need satisfaction
timeFrame: 4 weeks
Other outcomes:
measure: Location of engaging in PA
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Differences usage of gameplay
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Differences usage of game sessions
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Differences usage of game in interaction with other players
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Differences usage of game in invested game resources
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Differences usage of gameplay time
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Differences usage of gameplay location
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Usage of game physical activity
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Usage of game sedentary behaviour
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Ghent
name: Greet Cardon, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Ann DeSmet, Dr.
role: PRINCIPAL_INVESTIGATOR
References: