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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03659604
Other study ID # 'SmartLife' exergame
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date April 30, 2019

Study information

Verified date November 2021
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date April 30, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
'SmartLife' with tailored feedback
'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.
'SmartLife' without tailored feedback
'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.
No game
Passive control: School classes will be asked to continue their daily life as usual.

Locations

Country Name City State
Belgium Ghent University Hospital Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Ghent European Commission

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Location of engaging in PA Location of engaging in PA, measured by validated items (questionnaire) Baseline, 4 weeks, 8 weeks
Other Differences usage of gameplay Differences in usage of game between intervention group and active controle group, measured via log data of the game (total number gameplay minutes) (log data) 1 week, 2 weeks, 3 weeks, 4 weeks
Other Differences usage of game sessions Differences in usage of game between intervention group and active controle group, measured via log data of the game (total number gameplay sessions) (log data) 1 week, 2 weeks, 3 weeks, 4 weeks
Other Differences usage of game in interaction with other players Differences in usage of game between intervention group and active controle group, measured via log data of the game (total number of interactions with other players) (log data) 1 week, 2 weeks, 3 weeks, 4 weeks
Other Differences usage of game in invested game resources Differences in usage of game between intervention group and active controle group, measured via log data of the game (total number of invested game resources) (log data) 1 week, 2 weeks, 3 weeks, 4 weeks
Other Differences usage of gameplay time Differences in usage of game between intervention group and active controle group, measured via log data of the game (gameplay time: measured via 1-3, indicating morning, afternoon, evening) (log data) 1 week, 2 weeks, 3 weeks, 4 weeks
Other Differences usage of gameplay location Differences in usage of game between intervention group and active controle group, measured via log data of the game (gameplay location, indicating 1-2; 1=inside/2=outside) (log data) 1 week, 2 weeks, 3 weeks, 4 weeks
Other Usage of game physical activity Usage of game by intervention group, measured via log data of the game (average moderate to vigorous physical activity) (log data) 1 week, 2 weeks, 3 weeks, 4 weeks
Other Usage of game sedentary behaviour Usage of game by intervention group, measured via log data of the game (sedentary behaviour) (log data) 1 week, 2 weeks, 3 weeks, 4 weeks
Primary 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 Change in objectively measured sedentary behavior (SB) Change in amount of total sitting time, measured via accelerometers Baseline, 4 weeks, 8 weeks
Secondary Change in subjectively measured Body Mass Index (BMI) Change in BMI, measured via self-reported weight and height Baseline
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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