NCT03659604

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

August 23, 2018

Last Update Submit

November 29, 2021

Conditions

Physical ActivityHealth Behavior

Keywords

physical activitysedentary behaviorserious gameexergamebehaviour change techniquestailored feedback

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in objectively measured sedentary behavior (SB)

    Baseline, 4 weeks, 8 weeks

  • Change in subjectively measured Body Mass Index (BMI)

    Baseline

  • Change in determinants of PA

    Baseline, 4 weeks, 8 weeks

  • Change in determinants of SB

    Baseline, 4 weeks, 8 weeks

  • Change in behavior of PA

    Baseline, 4 weeks, 8 weeks

  • +2 more secondary outcomes

Other Outcomes (9)

  • Location of engaging in PA

    Baseline, 4 weeks, 8 weeks

  • Differences usage of gameplay

    1 week, 2 weeks, 3 weeks, 4 weeks

  • Differences usage of game sessions

    1 week, 2 weeks, 3 weeks, 4 weeks

  • +6 more other outcomes

Study Arms (3)

Experimental with tailored feedback

EXPERIMENTAL

'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

Active control without tailored feedback

ACTIVE COMPARATOR

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

Behavioral: 'SmartLife' without tailored feedback

Passive control

OTHER

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

Behavioral: No game

Interventions

'SmartLife' with tailored feedbackBEHAVIORAL

'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.

Experimental with tailored feedback
'SmartLife' without tailored feedbackBEHAVIORAL

'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.

Active control without tailored feedback
No gameBEHAVIORAL

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

Passive control

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Between 12-18 years old
  • Access to an Android smartphone (4.0.1) during study period
  • No physical disabilities that hinder physical activity

You may not qualify if:

  • Not Dutch-speaking
  • Does not have access to an Android smartphone (4.0.1)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Motor ActivityHealth BehaviorSedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Greet Cardon, Professor

    University Ghent

    PRINCIPAL INVESTIGATOR

  • Ann DeSmet, Dr.

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

September 6, 2018

Study Start

September 1, 2018

Primary Completion

March 31, 2019

Study Completion

April 30, 2019

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)