An interventional study of Boosth in Physical Activity, Serious Game and Childhood Obesity, sponsored by Maastricht University Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-10-08.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's enrollment of 52 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 114 are open to participants now.
Compared within Pediatric Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children in the intervention group will receive Boosth: Boosth activity tracker, Boosth syncc app and Boosth game app
Device: Boosth
Standard care
Boosth activity tracker which measures steps
change in moderate to vigorous physical activity (min/day)
moderate to vigorous physical activity (min/day) as measured with the Actigraph accelerometer
Time frame: 1 week weartime at baseline, 3, 6 and 12 months
Change in step count
Daily step count via Boosth activity tracker
Time frame: 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.
Time frame: up to 12 months
Anthropometry
Weight (kg) and height (cm) will be combined to report BMI in kg/m\^2
Time frame: up to 12 months
Body composition
Fat Mass and Fat Free Mass via Bodpod measurement
Time frame: up to 12 months
Energy Expenditure
Energy expenditure as measured with indirect calorimetrie
Time frame: 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.
Time frame: up to 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Dec 2020, 36 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maastricht University Medical Center →