Physical ActivityNCT03435575
BOOSTH: Serious Gaming in Combination With Physical Activity Promotion
A study testing Boosth in people with Physical Activity and Serious Game, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Physical inactivity is considered to be one of the ten principal risk factors for death worldwide. Children need to perform one hour of daily moderate-to-vigorous intensity physical activity whereof at least twice a week these activities are of vigorous intensity. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Physical Activity, Serious Game, Childhood Obesity
- What is being tested?
- Boosth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Nov 2017to 1 Sep 2021
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys and girls, aged between 8 and 12 years (at time of inclusion)
- Overweight or obesity according to IOTF criteria Are enrolled in the COACH program
- Have access to a technological device (i.e. tablet, iPad, phone) with bluetooth option (to synchronize activity points and playing the BOOSTH game)
Who cannot join
- Children who are suffering from any musculoskeletal condition that would prevent the subject from performing PA.
- Children who already participate in another PA intervention (children who are attending COACH Sports lessons will be excluded)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Physical inactivity is considered to be one of the ten principal risk factors for death worldwide. Children need to perform one hour of daily moderate-to-vigorous intensity physical activity whereof at least twice a week these activities are of vigorous intensity. In 2010, the percentage of 4-11 year-old normoactive Dutch children was approximately 20%. In addition, there is a dose-response relationship between BMI by sex and physical activity levels. Previous interventions that aimed to increase childhood physical activity produced small to negligible effects. One possible explanation is that individuals were not intrinsically motivated towards PA during the intervention period. Children spend a substantial amount of their time behind a game consule. There are a number of applications that motivate increase in PA in a fun way through engaging individuals in games that mix real and computing worlds. These games became known as serious games. In this study we want to investigate if the incorporation of a serious game BOOSTH in combination with an activity tracker to stimulate physical activity behaviour in overweight/ obese children.
Read the detailed description
The investigational treatment consists of regular COACH care and the BOOSTH physical activity intervention. Children in the intervention group will start with the physical activity intervention. The child will receive the BOOSTH activity tracker. The child (under supervision of their parents) needs to download the BOOSTH sync app and the BOOSTH game app. Therefore it is important that the child or their parents have a device with Bluetooth. The investigators create a login account for the child. After installing the apps, the activity tracker measures step counts which are translated into activity points. These activity points will be used to unlock levels in the BOOSTH game app. The child synchronizes their activity points, with Bluetooth connection, in the BOOSTH sync app and immediately the child could open the BOOSTH game app to play a level in the game. The child needs seven green lights (corresponding to 30 minutes of performed physical activity) to unlock a level in the game. The first four levels are for free, to gain interests of the child, but thereafter the child needs to be physically active to unlock the rest of the levels in the game. The intervention consists of a combination of supporting strategies: • BOOSTH game: it is a reward based game since the child needs to perform physical activity to unlock a level in the game. The BOOSTH game is a jump and run game. • Lights on the activity tracker: the child will be stimulated to promote physical activity by using green lights on the activity tracker. The more performed physical activity, the more green lights on the activity tracker (maximum of seven green lights). When the maximum is reached the child could use the activity points to unlock a level in the game. • Group system: a special COACH group (in the BOOSTH game app) will be created. Children can compare their scores with each other and challenge each other to gain more activity points. • Every week the child receives a reminder (by email or phone) to promote physical activity. Every week the researcher will download the BOOSTH data. Individual adjustments and encouragement could be made based on results of the data. • The medical doctor (MD) will stimulate physical activity behavior during regular COACH visits and promote the use of BOOSTH The intervention duration is 6 months. Measurements will be performed at baseline, 3-, 6- and twelve months after the start.
- Being tested
- Boosth
- Keywords
- physical activity, serious game, childhood obesity
- Medical subject headings
- Motor Activity, Pediatric Obesity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoosthDevice
Boosth activity tracker which measures steps
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Children in the intervention group will receive Boosth: Boosth activity tracker, Boosth syncc app and Boosth game app Receives: Device: Boosth |
| Control group | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in moderate to vigorous physical activity (min/day)
moderate to vigorous physical activity (min/day) as measured with the Actigraph accelerometer
Measured: 1 week weartime at baseline, 3, 6 and 12 months
Secondary outcomes (6)
Change in step count
Daily step count via Boosth activity tracker
Measured: up to 6 months
Change in physical activity behaviour
Subjective physical activity behaviour via Baecke questionnaire. BAECKE (for children) will be used to assess the amount of habitual PA ranging from 1 (lowest activity) to 5 (highest activity). Physical activity at school, during leisure time and organized sports will be asked.
Measured: up to 12 months
Anthropometry
Weight (kg) and height (cm) will be combined to report BMI in kg/m^2
Measured: up to 12 months
Body composition
Fat Mass and Fat Free Mass via Bodpod measurement
Measured: up to 12 months
Energy Expenditure
Energy expenditure as measured with indirect calorimetrie
Measured: up to 6 months
Screentime
Screentime as measured with questionnaire. Subjects and their parents will report the average hours per day (weekday and weekend day) of screen-time (hours/day). Screen-time are activities like watching T.V., use of computer, playing videogames and the use of social media like Facebook or Instagram. Self-reported screen time will be reported separately for weekday and weekend day assessed with the following questions: 'How many hours a day during the last 4 weeks you watched TV on a normal weekday/weekend?' and 'How many hours a day during the last 4 weeks have you played console games or used a computer for your free time activities on a normal weekday/weekend? Possible responses are: 'not at all', '0.5 hours per day', 'one hour per day', '2 hours per day', '2.5 hours per day', '3 hours per day', '3.5 hours per day', '4 hours or more per day'. Total screen time was calculated by summing minutes spent in TV watching and computer use.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start9 Nov 2017
- Primary completion1 Dec 2020
- Study completion1 Sep 2021
Why it stopped: Inclusion rate not reached and due to the COVID-19 pandemic not enough follow up measurements of the included participants.
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control group parallel
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Vreugdenhil, Dr, Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435575
- Sponsor's protocol ID
- NL61033.000.17
- Status last verified
- Sep 2021
- First submitted
- 29 Jan 2018
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOOSTH: Serious Gaming in Combination With Physical Activity Promotion
- ClinicalTrials.gov ID
- NCT03435575
- Acronym / sponsor ID
- NL61033.000.17
- Keywords
- physical activity, serious game, childhood obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion rate not reached and due to the COVID-19 pandemic not enough follow up measurements of the included participants.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 19 Feb 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.
Physical inactivity is considered to be one of the ten principal risk factors for death worldwide. Children need to perform one hour of daily moderate-to-vigorous intensity physical activity whereof at least twice a week these activities are of vigorous intensity. In 2010, the percentage of 4-11 year-old normoactive Dutch children was approximately 20%. In addition, there is a dose-response relationship between BMI by sex and physical activity levels. Previous interventions that aimed to increase childhood physical activity produced small to negligible effects. One possible explanation is that individuals were not intrinsically motivated towards PA during the intervention period. Children spend a substantial amount of their time behind a game consule. There are a number of applications that motivate increase in PA in a fun way through engaging individuals in games that mix real and computing worlds. These games became known as serious games. In this study we want to investigate if the incorporation of a serious game BOOSTH in combination with an activity tracker to stimulate physical activity behaviour in overweight/ obese children.
Detailed description
The investigational treatment consists of regular COACH care and the BOOSTH physical activity intervention. Children in the intervention group will start with the physical activity intervention. The child will receive the BOOSTH activity tracker. The child (under supervision of their parents) needs to download the BOOSTH sync app and the BOOSTH game app. Therefore it is important that the child or their parents have a device with Bluetooth. The investigators create a login account for the child. After installing the apps, the activity tracker measures step counts which are translated into activity points. These activity points will be used to unlock levels in the BOOSTH game app. The child synchronizes their activity points, with Bluetooth connection, in the BOOSTH sync app and immediately the child could open the BOOSTH game app to play a level in the game. The child needs seven green lights (corresponding to 30 minutes of performed physical activity) to unlock a level in the game. The first four levels are for free, to gain interests of the child, but thereafter the child needs to be physically active to unlock the rest of the levels in the game. The intervention consists of a combination of supporting strategies: • BOOSTH game: it is a reward based game since the child needs to perform physical activity to unlock a level in the game. The BOOSTH game is a jump and run game. • Lights on the activity tracker: the child will be stimulated to promote physical activity by using green lights on the activity tracker. The more performed physical activity, the more green lights on the activity tracker (maximum of seven green lights). When the maximum is reached the child could use the activity points to unlock a level in the game. • Group system: a special COACH group (in the BOOSTH game app) will be created. Children can compare their scores with each other and challenge each other to gain more activity points. • Every week the child receives a reminder (by email or phone) to promote physical activity. Every week the researcher will download the BOOSTH data. Individual adjustments and encouragement could be made based on results of the data. • The medical doctor (MD) will stimulate physical activity behavior during regular COACH visits and promote the use of BOOSTH The intervention duration is 6 months. Measurements will be performed at baseline, 3-, 6- and twelve months after the start.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention and control group parallel
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Device: BoosthChildren in the intervention group will receive Boosth: Boosth activity tracker, Boosth syncc app and Boosth game app |
| Control group | No intervention | –Standard care |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Boys and girls, aged between 8 and 12 years (at time of inclusion)
- Overweight or obesity according to IOTF criteria Are enrolled in the COACH program
- Have access to a technological device (i.e. tablet, iPad, phone) with bluetooth option (to synchronize activity points and playing the BOOSTH game)
Key exclusion criteria (2 listed)
- Children who are suffering from any musculoskeletal condition that would prevent the subject from performing PA.
- Children who already participate in another PA intervention (children who are attending COACH Sports lessons will be excluded)
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 |
|---|---|---|
| BoosthBoosth activity tracker which measures steps | Device | Intervention group |
Primary outcome
change in moderate to vigorous physical activity (min/day)
Time frame: 1 week weartime at baseline, 3, 6 and 12 months
moderate to vigorous physical activity (min/day) as measured with the Actigraph accelerometer
6 secondary outcomes
Change in step count
Time frame: up to 6 months
Change in physical activity behaviour
Time frame: up to 12 months
Anthropometry
Time frame: up to 12 months
Body composition
Time frame: up to 12 months
Energy Expenditure
Time frame: up to 6 months
Screentime
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: Inclusion rate not reached and due to the COVID-19 pandemic not enough follow up measurements of the included participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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.
Anita Vreugdenhil, Dr study chair
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boosth in people with Physical Activity and Serious Game, run by Maastricht University Medical Center at 1 site in Netherlands.
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: stopped early, as of the sponsor's last update on 8 Oct 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 Netherlands. 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 was stopped early (reason given: Inclusion rate not reached and due to the COVID-19 pandemic not enough follow up measurements of the included participants.). Results are not available in the source record.
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 moderate to vigorous physical activity (min/day) (time frame: 1 week weartime at baseline, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2021.