Effectiveness of and Engagement in a Mobile Exergame With Tailored Feedback

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

Study Overview

• Status: Completed
• Conditions: Physical Activity; Health Behavior
• Intervention / Treatment: Behavioral: 'SmartLife' with tailored feedback; Behavioral: 'SmartLife' without tailored feedback; Behavioral: No game

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Location of engaging in PA	Location of engaging in PA, measured by validated items (questionnaire)	Baseline, 4 weeks, 8 weeks
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: European Commission
• Investigators: Principal Investigator: Greet Cardon, Professor, University Ghent; Principal Investigator: Ann DeSmet, Dr., University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; behaviour change techniques; sedentary behavior; serious game; exergame; tailored feedback
• Other Study ID Numbers: 'SmartLife' exergame

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No