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Completed

NCT Number: NCT03659604

Effectiveness of and Engagement in a Mobile Exergame With Tailored Feedback

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

'SmartLife' with tailored feedback

Behavioral

'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

Behavioral

'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

Behavioral

Passive control: School classes will be asked to continue their daily life as usual.

Primary outcomes

  1. Change in objectively measured physical activity (PA)

    Time frame: Baseline, 4 weeks, 8 weeks

    Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers

Secondary outcomes

  1. Change in objectively measured sedentary behavior (SB)

    Time frame: Baseline, 4 weeks, 8 weeks

    Change in amount of total sitting time, measured via accelerometers

  2. Change in subjectively measured Body Mass Index (BMI)

    Time frame: Baseline

    Change in BMI, measured via self-reported weight and height

  3. Change in determinants of PA

    Time frame: Baseline, 4 weeks, 8 weeks

    Change in attitude, parental support, friends' co-participation, perceived social norm, self-efficacy, perceived benefits, perceived barriers, measured by validated items (questionnaire)

  4. Change in determinants of SB

    Time frame: Baseline, 4 weeks, 8 weeks

    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).

  5. Change in behavior of PA

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

  6. Differences in engagement

    Time frame: 4 weeks

    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.

  7. Differences in basic need satisfaction

    Time frame: 4 weeks

    Differences in basis need satisfaction between intervention group and active cotrol group, measured via 14 validated items (questionnaire)

Other outcomes

  1. Location of engaging in PA

    Time frame: Baseline, 4 weeks, 8 weeks

    Location of engaging in PA, measured by validated items (questionnaire)

  2. Differences usage of gameplay

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

    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)

  3. Differences usage of game sessions

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

    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)

  4. Differences usage of game in interaction with other players

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

    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)

  5. Differences usage of game in invested game resources

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

    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)

  6. Differences usage of gameplay time

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

    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)

  7. Differences usage of gameplay location

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

    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)

  8. Usage of game physical activity

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

    Usage of game by intervention group, measured via log data of the game (average moderate to vigorous physical activity) (log data)

  9. Usage of game sedentary behaviour

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

    Usage of game by intervention group, measured via log data of the game (sedentary behaviour) (log data)

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • European Commission

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2018
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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