Effectiveness of and Engagement in a Mobile Exergame With Tailored Feedback

Sponsor
University Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT03659604
Collaborator
European Commission (Other)
240
1
3
7.9
30.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 'SmartLife' with tailored feedback
  • Behavioral: 'SmartLife' without tailored feedback
  • Behavioral: No game
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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).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)
Primary Purpose:
Prevention
Official Title:
A Clustered Randomized Controlled Trial to Compare the Effectiveness of and Engagement in a Mobile Exergame 'SmartLife' With Tailored Feedback
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Mar 31, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental with tailored feedback

'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
'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.

Active Comparator: Active control without tailored feedback

'SmartLife' without tailored feedback: School classes will receive the developed 'SmartLife' intervention without tailored feedback.

Behavioral: '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.

Other: Passive control

School classes will not receive any intervention, thus no game.

Behavioral: No game
Passive control: School classes will be asked to continue their daily life as usual.

Outcome Measures

Primary Outcome Measures

  1. Change in objectively measured physical activity (PA) [Baseline, 4 weeks, 8 weeks]

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

Secondary Outcome Measures

  1. Change in objectively measured sedentary behavior (SB) [Baseline, 4 weeks, 8 weeks]

    Change in amount of total sitting time, measured via accelerometers

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

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

  3. Change in determinants of PA [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 [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 [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 [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 [4 weeks]

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

Other Outcome Measures

  1. Location of engaging in PA [Baseline, 4 weeks, 8 weeks]

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

  2. Differences usage of gameplay [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 [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 [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 [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 [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 [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ghent University Hospital Ghent Belgium 9000

Sponsors and Collaborators

  • University Ghent
  • European Commission

Investigators

  • Principal Investigator: Greet Cardon, Professor, University Ghent
  • Principal Investigator: Ann DeSmet, Dr., University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Ghent
ClinicalTrials.gov Identifier:
NCT03659604
Other Study ID Numbers:
  • 'SmartLife' exergame
First Posted:
Sep 6, 2018
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Ghent

Study Results

No Results Posted as of Nov 30, 2021