Clinical trial NCT03440580: BOOSTH: Promoting Physical Activity in Primary Schools in Combination With Serious Gaming
Official title: BOOSTH: Promoting Physical Activity in Primary Schools in Combination With Serious Gaming
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Serious Game
Child Behavior
School Intervention
Keywords: physical activity
serious game
school intervention
children
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 713
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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%.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.

Eligibility criteria: Inclusion criteria:

* 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.

Primary outcomes:
measure: moderate to vigorous physical activity (min/day)
timeFrame: up to twelve months
Secondary outcomes:
measure: change in step count
timeFrame: up to twelve months
measure: change in physical activity behaviour
timeFrame: up to twelve months
measure: BMI-z score
timeFrame: up to twelve months
measure: motivation towards physical activity
timeFrame: up to twelve months (measurement at baseline,3-, 6- and 12 months)
measure: screen-time
timeFrame: up to twelve months (measurement at baseline,3-, 6- and 12 months)
measure: Quality of life (Kidscreen)
timeFrame: up to twelve months (measurement at baseline,3-, 6- and 12 months)
measure: Quality of life (PedsQL)
timeFrame: up to twelve months (measurement at baseline,3-, 6- and 12 months)
measure: Cardiovascular alterations (Pulse Wave Velocity)
timeFrame: up to twelve months (measurement at baseline and 12 months)
measure: Blood pressure
timeFrame: up to twelve months (measurement at baseline and 12 months)
measure: Cardiovascular alterations (retinal image)
timeFrame: up to twelve months (measurement at baseline and 12 months)
measure: Aerobic fitness
timeFrame: up to twelve months (measurement at baseline and 12 months)
Other outcomes:
measure: Comprehensive General Parenting Questionnaire
timeFrame: up to twelve months (measurement at baseline and 6 months)
measure: parenting practices questionnaire
timeFrame: up to twelve months (measurement at baseline and 6 months)
measure: Process evaluation
timeFrame: up to 6 months (measurement at 3- and 6 months)
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Anita Vreugdenhil, Dr
role: STUDY_CHAIR
References:
citation: 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.
citation: Velde 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.
citation: Ten 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.