|- candidate number||27181|
|- NTR Number||NTR6448|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-mei-2017|
|- Secondary IDs||NL61033.000.17 METC|
|- Public Title||We BOOSTH Limburg |
|- Scientific Title||BOOSTH: serious gaming in combination with physical activity promotion |
|- hypothesis||The addition of BOOSTH to the multidisciplinary COACH program intrinsically motivates children to perform more moderate to vigorous physical activity behavior (min/day) so that this effect will be sustained even though the initial interest in BOOSTH may disappear. |
|- Healt Condition(s) or Problem(s) studied||Children, Obesity, Physical activity|
|- Inclusion criteria||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 B
|- Exclusion criteria||Children who are suffering from any musculoskeletal condition that would prevent the subject from performing PA.|
Children who already participate in another PA intervention
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jun-2017|
|- planned closingdate||1-dec-2019|
|- Target number of participants||56|
|- Interventions||The investigational treatment consists of regular COACH care and the BOOSTH PA intervention. First, the baseline measurement will take place. Thereafter the child will be randomized into the intervention or the control group. Children in the intervention group will start with the PA 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. We 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 PA) 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 PA 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 PA by using green lights on the activity tracker. The more performed PA, 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 PA. 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 PA behavior during regular COACH visits and promote the use of BOOSTH
The intervention duration is 6 months. Measurements will take place 3, 6 and 12 months after the start of the intervention. After the intervention, the children are allowed to keep BOOSTH. After the intervention period the child will not be stimulated anymore (by sending reminders or by the MD) to use BOOSTH.
|- Primary outcome||The primary endpoint is moderate to vigorous physical activity (min) as measured with the Actigraph G3X+ accelerometer. |
|- Secondary outcome||• Objectively measured step count via BOOSTH activity tracker |
• Objectively measured total PA and sedentary behaviour (low PA levels) as measured with the Actigraph GT3X accelerometer
• Subjectively measured PA behaviour via the BAECKE questionnaire
• Motivation towards PA as measured with the BREQ questionnaire
• Anthropometry as measured via BMI-Z score (lenght and weight measurements) and weight circumference
• Body composition (i.e. fat mass and fat free mass) will be investigated (at baseline and at six months after the start of the intervention) as measured via BodPod
• Energy expenditure as measured with indirect calorimetry
• Screen time by asking the amount of screentime on a weekday and a weekendday.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Gabrielle ten Velde|
|- CONTACT for SCIENTIFIC QUERIES|| A.C.E. Vreugdenhil|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Province of Limburg|
|- Brief 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. 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. |
|- Main changes (audit trail)|
|- RECORD||9-mei-2017 - 30-jun-2017|