Physical ActivityNCT03659604

Effectiveness of and Engagement in a Mobile Exergame With Tailored Feedback

A study testing 'SmartLife' with tailored feedback, 'SmartLife' without tailored feedback and No game in people with Physical Activity and Health Behavior, run by University Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Physical Activity, Health Behavior
What is being tested?: 'SmartLife' with tailored feedback, 'SmartLife' without tailored feedback and No game
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteBelgium
Study dates: 1 Sep 2018to 30 Apr 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Ghent University Hospital
Ghent, 9000

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Conditions: Physical Activity, Health Behavior
Being tested: 'SmartLife' with tailored feedback, 'SmartLife' without tailored feedback, No game
Keywords: physical activity, sedentary behavior, serious game, exergame, behaviour change techniques, tailored feedback
Medical subject headings: Motor Activity, Health Behavior, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

'SmartLife' with tailored feedbackBehavioural
'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 feedbackBehavioural
'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 gameBehavioural
Passive control: School classes will be asked to continue their daily life as usual.

Study groups in NCT03659604
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: 'SmartLife' without tailored feedback
Passive control	Other	School classes will not receive any intervention, thus no game. Receives: Behavioral: No game

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in objectively measured physical activity (PA)
Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers
Measured: Baseline, 4 weeks, 8 weeks

Secondary outcomes (7)

Change in objectively measured sedentary behavior (SB)
Change in amount of total sitting time, measured via accelerometers
Measured: Baseline, 4 weeks, 8 weeks
Change in subjectively measured Body Mass Index (BMI)
Change in BMI, measured via self-reported weight and height
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201830 Apr 2019

First posted6 Sep 2018
Study start1 Sep 2018
Primary completion31 Mar 2019
Study completion30 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Physical ActivityStudies of the same condition, open and under way.
More trials run by University GhentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03659604
Sponsor's protocol ID: 'SmartLife' exergame
Status last verified: Nov 2021
First submitted: 23 Aug 2018
Last updated: 30 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Physical Activity trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clustered Randomized Controlled Trial to Compare the Effectiveness of and Engagement in a Mobile Exergame 'SmartLife' With Tailored Feedback
ClinicalTrials.gov ID: NCT03659604
Acronym / sponsor ID: 'SmartLife' exergame
Conditions: Physical Activity, Health Behavior
Keywords: physical activity, sedentary behavior, serious game, exergame, behaviour change techniques, tailored feedback
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: University GhentUniversity, hospital or other
Collaborators: European Commission
Study start: 1 Sep 2018 (actual)
Primary completion: 31 Mar 2019 (actual)
Study completion: 30 Apr 2019 (actual)
First posted: 6 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
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).

Arm	Type	Receives
Experimental with tailored feedback	Experimental	Behavioral: 'SmartLife' 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.
Active control without tailored feedback	Active comparator	Behavioral: 'SmartLife' without tailored feedback'SmartLife' without tailored feedback: School classes will receive the developed 'SmartLife' intervention without tailored feedback.
Passive control	Other	Behavioral: No gameSchool classes will not receive any intervention, thus no game.

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
'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.	Behavioural	Experimental with tailored feedback
'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.	Behavioural	Active control without tailored feedback
No gamePassive control: School classes will be asked to continue their daily life as usual.	Behavioural	Passive control

Primary outcome

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

7 secondary outcomes

Change in objectively measured sedentary behavior (SB)
Time frame: Baseline, 4 weeks, 8 weeks
Change in subjectively measured Body Mass Index (BMI)
Time frame: Baseline
Change in determinants of PA
Time frame: Baseline, 4 weeks, 8 weeks
Change in determinants of SB
Time frame: Baseline, 4 weeks, 8 weeks
Change in behavior of PA
Time frame: Baseline, 4 weeks, 8 weeks
Differences in engagement
Time frame: 4 weeks
Differences in basic need satisfaction
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Greet Cardon, Professor principal investigator

University Ghent

Ann DeSmet, Dr. principal investigator

University Ghent

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in objectively measured physical activity (PA) (time frame: Baseline, 4 weeks, 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03659604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.