BOOSTH: Promoting Physical Activity in Primary Schools in Combination With Serious Gaming

Physical Activity Clinical Trial

Official title:

BOOSTH: Promoting Physical Activity in Primary Schools in Combination With Serious Gaming

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440580
• Other study ID #: METC 172043
• Status: Completed
• Phase: N/A
• Start date: August 17, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2020
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 713
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Behavior
• Physical Activity
• School Intervention
• Serious Game

Intervention

Device:
• BOOSTH
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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comprehensive General Parenting Questionnaire	Parenting style as measured with CGPQ. The 85 item Comprehensive General Parenting Questionnaire (CGPQ) will be used to assess general parenting on a five - factor parenting model. This questionnaire is validated with Dutch parents questionnaire.	up to twelve months (measurement at baseline and 6 months)
Other	parenting practices questionnaire	Parenting style as measured with parenting practices questionnaire. The physical activity parenting practice questionnaire assess parents practice style regarding physical activity and sedentary behavior. The questionnaire consists of 5 questions on a 5point scale.	up to twelve months (measurement at baseline and 6 months)
Other	Process evaluation	Process evaluation Semi- structured focus groups will be caried out with teachers from the intervention schools. The interview covers all aspects of the intervention, including the measurements, introduction lesson of Boosth, the intervention and the follow up. Interviews will be recorded. Booking logs: will be used to assess intervention reach and dose. Evaluation questionnaire: children and their parents will fill in an evaluation questionnaire about the use of BOOSTH. Teachers will fill in an evaluation questionnaire about the methods and implementation about the BOOSTH intervention. Teachers of the control school will fill in an questionnaire to find out whether any unplanned intervention may contaminated the evaluation.	up to 6 months (measurement at 3- and 6 months)
Primary	moderate to vigorous physical activity (min/day)	change in moderate to vigorous physical activity (min/day) as measured with accelerometry	up to twelve months
Secondary	change in step count	step count as measured with the Boosth activity tracker	up to twelve months
Secondary	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.	up to twelve months
Secondary	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.	up to twelve months
Secondary	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.	up to twelve months (measurement at baseline,3-, 6- and 12 months)
Secondary	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.	up to twelve months (measurement at baseline,3-, 6- and 12 months)
Secondary	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	up to twelve months (measurement at baseline,3-, 6- and 12 months)
Secondary	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.	up to twelve months (measurement at baseline,3-, 6- and 12 months)
Secondary	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).	up to twelve months (measurement at baseline and 12 months)
Secondary	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	up to twelve months (measurement at baseline and 12 months)
Secondary	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	up to twelve months (measurement at baseline and 12 months)
Secondary	Aerobic fitness	aerobic fitness as measured with the 20m shuttle run test	up to twelve months (measurement at baseline and 12 months)

External Links

•   boosth website