Physical ActivityNCT03440580
BOOSTH: Promoting Physical Activity in Primary Schools in Combination With Serious Gaming
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 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Serious Game, Child Behavior
- What is being tested?
- BOOSTH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 713 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Aug 2018to 1 Jul 2020
- 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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The school needs to be located in the Limburg- region of the Netherlands.
- At least 25 students enrolled in grades 5, 6 and 7
- The school works with a technological device with Bluetooth option to synchronize activity points
- Boys and girls, in 5th to 7th grade
- Informed consent signed by both parents and children aged 12 years and older.
- Exlusion criteria
- Children who are wheelchair dependent.
- The school has plans to merge with another school or plans to relocate in the upcoming year.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229HX
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%.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 physical activity 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 physical activity 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 and battle to stimulate physical activity behaviour in primary school children (grades 5th to 7th).
Read the detailed description
The study design will be a randomized controlled trial regarding a physical activity intervention. A 1:1 randomization will be applied with intervention schools and matched control schools. The intervention school will recieve the BOOSTH intervention. The intervention duration is 6 months. Measurements will be performed at baseline and 3, 6 and 12 months after the start.
The investigational treatment is the BOOSTH physical activity intervention. Children in the intervention school will start with the BOOSTH intervention on top of the regular PE lessons. The child will receive the BOOSTH activity tracker. The child (under supervision of the teacher) needs to download the BOOSTH sync app and the BOOSTH game app. Therefore it is important that the school works with a device with Bluetooth. We will create a login account for each 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 can 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 the interests of the child, but thereafter the child needs to be physically active to unlock the rest of the levels in the game.
- Conditions
- Physical Activity, Serious Game, Child Behavior, School Intervention
- Being tested
- BOOSTH
- Keywords
- physical activity, serious game, school intervention, children
- Medical subject headings
- Motor Activity, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOOSTHDevice
BOOSTH as a serious game is used as a tool to motivate children to perform more PA. BOOSTH uses the combination of a smartphone game and a pedometer that assesses daily PA by measuring steps/day. The BOOSTH activity monitor is a wrist-worn activity monitor that is able to provide online feedback on the child's PA levels. Moreover, BOOSTH is a reward-based game as a child is given incentive to increase their PA level, in order to acquire activity points which later can be used to unlock levels and progress in the BOOSTH game.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | The intervention school will receive the BOOSTH intervention: Boosth activity tracker, Boosth sync app, Boosht game app Receives: Device: BOOSTH |
| control group | No intervention | The control school will receive the standard curriculum. After the study is finished the children of the control school will receive the Boosth product |
What is being measured
The primary outcome is the main question the study is designed to answer.
moderate to vigorous physical activity (min/day)
change in moderate to vigorous physical activity (min/day) as measured with accelerometry
Measured: up to twelve months
Secondary outcomes (11)
change in step count
step count as measured with the Boosth activity tracker
Measured: up to twelve months
change in physical activity behaviour
subjectively measured physical activity behaviour with 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 twelve months
BMI-z score
change in BMI- z score. BMI is calculated as weight (kilograms) divided by height (meters) squared. for children the BMI threshold of obesity varies with age and sex.
Measured: up to twelve months
motivation towards physical activity
motivation towards physical activity as measured with BREQ questionnaire. The BREQ2 is a self-administered questionnaire about a motivation continuum towards PA. The BREQ2 measures external, introjected, identified, integrated and intrinsic forms of motivation of PA behavior. The questionnaire consists of 19 thesis's on a 5-point Likert scale, providing subscores for all forms of regulation. The BREQ2 is a self-administered questionnaire about a motivation continuum towards PA. The BREQ2 measures external, introjected, identified, integrated and intrinsic forms of motivation of PA behavior. The questionnaire consists of 19 thesis's on a 5-point Likert scale, providing subscores for all forms of regulation.
Measured: up to twelve months (measurement at baseline,3-, 6- and 12 months)
screen-time
screen- time as measured with questionnaire. 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 twelve months (measurement at baseline,3-, 6- and 12 months)
Quality of life (Kidscreen)
Quality of life as measured with Kidscreen. The Kidsreen instruments assess children's and adolescents' subjective health and well-being. They were developed as self-report measures applicable for healthy and chronically ill children and adolescents aged from 8 to 18 years. The Kidsscreen-27 version provides a global health related quality of life score and consists of 27 questions.Higher scores represent a better quality of life
Measured: up to twelve months (measurement at baseline,3-, 6- and 12 months)
Quality of life (PedsQL)
Quality of life as measured with PedsQL questionnaire. The 23-item PedsQL Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. The 4 Multidimensional Scales are: physical functioning, emotional functioning, social functioning and school functioning. Summary scores will be calculated for total scale score, physical health summary score and psychosocial health summary score.
Measured: up to twelve months (measurement at baseline,3-, 6- and 12 months)
Cardiovascular alterations (Pulse Wave Velocity)
pulse wave velocity (PWV). will be measured using a SphygmoCor (CPV) device. Carotidfemoral (cf) as well as -radial (cr) PWV will be measured. Measurement of cr PWV in addition to cf PWV is no extra burden to the subjects and will take only a few extra minutes. Obtained waveforms are processed with dedicated software (SphygmoCor version 7, AtCor).
Measured: up to twelve months (measurement at baseline and 12 months)
Blood pressure
blood pressure. Systolic and diastolic blood pressure will be measured using a validated automatic device on the right arm after 5-10 minutes rest in a resting position. The measurement is taken three times with a 1 minute rest between, and the reading is recorded to the nearest 1 mmHg. A mean value of these three readings is used
Measured: up to twelve months (measurement at baseline and 12 months)
Cardiovascular alterations (retinal image)
Retinal image. Children are seated with the head resting on a chinrest, looking directly into the camera (Topcon TRC-NW-300, Topcon Corporation, Tokyo, Japan). The fundus camera will focus on and take a picture of the retina. The total procedure will take about 2 minutes. Images will be digitised and analysed to calculate the arteriovenous ratio (AVratio) with the appropriate software (Generalized Dual-Bootstrap Iterative Closest Point (GDB-ICP)) that is able to automatically initialise and individually match vascular landmarks. In addition, the software will be used to measure the diameter of the four largest retinal arterioles and venules
Measured: up to twelve months (measurement at baseline and 12 months)
Aerobic fitness
aerobic fitness as measured with the 20m shuttle run test
Measured: up to twelve months (measurement at baseline and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start17 Aug 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design will be a randomized controlled trial regarding a physical activity intervention. A 1:1 randomization will be applied with intervention schools and matched control schools. The intervention school will recieve the BOOSTH intervention
- Masking
- None (open label)
- Enrolment
- 713 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
- NCT03440580
- Sponsor's protocol ID
- METC 172043
- Status last verified
- Sep 2020
- First submitted
- 30 Jan 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
PubMed 34555181Velde GT, Plasqui G, Willeboordse M, Winkens B, Vreugdenhil A. Associations between physical activity, sedentary time and cardiovascular risk factors among Dutch children. PLoS One. 2021 Aug 27;16(8):e0256448. doi: 10.1371/journal.pone.0256448. eCollection 2021.
PubMed 34449807Ten Velde G, Plasqui G, Willeboordse M, Winkens B, Vreugdenhil A. Feasibility and Effect of the Exergame BOOSTH Introduced to Improve Physical Activity and Health in Children: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 11;9(12):e24035. doi: 10.2196/24035.
PubMed 33306031
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOOSTH: Promoting Physical Activity in Primary Schools in Combination With Serious Gaming
- ClinicalTrials.gov ID
- NCT03440580
- Acronym / sponsor ID
- METC 172043
- Conditions
- Physical Activity, Serious Game, Child Behavior, School Intervention
- Keywords
- physical activity, serious game, school intervention, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 22 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%.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 physical activity 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 physical activity 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 and battle to stimulate physical activity behaviour in primary school children (grades 5th to 7th).
Detailed description
The study design will be a randomized controlled trial regarding a physical activity intervention. A 1:1 randomization will be applied with intervention schools and matched control schools. The intervention school will recieve the BOOSTH intervention. The intervention duration is 6 months. Measurements will be performed at baseline and 3, 6 and 12 months after the start.
The investigational treatment is the BOOSTH physical activity intervention. Children in the intervention school will start with the BOOSTH intervention on top of the regular PE lessons. The child will receive the BOOSTH activity tracker. The child (under supervision of the teacher) needs to download the BOOSTH sync app and the BOOSTH game app. Therefore it is important that the school works with a device with Bluetooth. We will create a login account for each 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 can 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 the interests of the child, but thereafter the child needs to be physically active to unlock the rest of the levels in the game.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design will be a randomized controlled trial regarding a physical activity intervention. A 1:1 randomization will be applied with intervention schools and matched control schools. The intervention school will recieve the BOOSTH intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: BOOSTHThe intervention school will receive the BOOSTH intervention: Boosth activity tracker, Boosth sync app, Boosht game app |
| control group | No intervention | –The control school will receive the standard curriculum. After the study is finished the children of the control school will receive the Boosth product |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The school needs to be located in the Limburg- region of the Netherlands.
- At least 25 students enrolled in grades 5, 6 and 7
- The school works with a technological device with Bluetooth option to synchronize activity points
- Boys and girls, in 5th to 7th grade
- Informed consent signed by both parents and children aged 12 years and older.
Key exclusion criteria (0 listed)
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 as a serious game is used as a tool to motivate children to perform more PA. BOOSTH uses the combination of a smartphone game and a pedometer that assesses daily PA by measuring steps/day. The BOOSTH activity monitor is a wrist-worn activity monitor that is able to provide online feedback on the child's PA levels. Moreover, BOOSTH is a reward-based game as a child is given incentive to increase their PA level, in order to acquire activity points which later can be used to unlock levels and progress in the BOOSTH game. | Device | Intervention |
Primary outcome
moderate to vigorous physical activity (min/day)
Time frame: up to twelve months
change in moderate to vigorous physical activity (min/day) as measured with accelerometry
11 secondary outcomes
change in step count
Time frame: up to twelve months
change in physical activity behaviour
Time frame: up to twelve months
BMI-z score
Time frame: up to twelve months
motivation towards physical activity
Time frame: up to twelve months (measurement at baseline,3-, 6- and 12 months)
screen-time
Time frame: up to twelve months (measurement at baseline,3-, 6- and 12 months)
Quality of life (Kidscreen)
Time frame: up to twelve months (measurement at baseline,3-, 6- and 12 months)
Quality of life (PedsQL)
Time frame: up to twelve months (measurement at baseline,3-, 6- and 12 months)
Cardiovascular alterations (Pulse Wave Velocity)
Time frame: up to twelve months (measurement at baseline and 12 months)
Blood pressure
Time frame: up to twelve months (measurement at baseline and 12 months)
Cardiovascular alterations (retinal image)
Time frame: up to twelve months (measurement at baseline and 12 months)
Aerobic fitness
Time frame: up to twelve months (measurement at baseline and 12 months)
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 3 Sep 2020.
- Derived from this study: PubMed 34555181Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
- Derived from this study: PubMed 34449807Velde GT, Plasqui G, Willeboordse M, Winkens B, Vreugdenhil A. Associations between physical activity, sedentary time and cardiovascular risk factors among Dutch children. PLoS One. 2021 Aug 27;16(8):e0256448. doi: 10.1371/journal.pone.0256448. eCollection 2021.
- Derived from this study: PubMed 33306031Ten Velde G, Plasqui G, Willeboordse M, Winkens B, Vreugdenhil A. Feasibility and Effect of the Exergame BOOSTH Introduced to Improve Physical Activity and Health in Children: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 11;9(12):e24035. doi: 10.2196/24035.
- 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 8 inclusion and 0 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 3 Sep 2020. 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 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?
moderate to vigorous physical activity (min/day) (time frame: up to twelve months). 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 NCT03440580, which also lists 3 linked publications.
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 3 Sep 2020.