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BOOSTH: Serious Gaming in Combination With Physical Activity Promotion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435575
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Physical Activity Serious Game Childhood Obesity Overweight and Obesity Device: Boosth Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention and control group parallel
Masking: None (Open Label)
Masking Description: Randomization into intervention or control group. Children in the intervention group will receive Boosth at the start of the study. Children in the control group will receive Boosth after the study is finished
Primary Purpose: Treatment
Official Title: BOOSTH: Serious Gaming in Combination With Physical Activity Promotion
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention group
Children in the intervention group will receive Boosth: Boosth activity tracker, Boosth syncc app and Boosth game app
Device: Boosth
Boosth activity tracker which measures steps

No Intervention: Control group
Standard care



Primary Outcome Measures :
  1. change in moderate to vigorous physical activity (min/day) [ Time Frame: 1 week weartime at baseline, 3, 6 and 12 months ]
    moderate to vigorous physical activity (min/day) as measured with the Actigraph accelerometer


Secondary Outcome Measures :
  1. Change in step count [ Time Frame: up to 6 months ]
    Daily step count via Boosth activity tracker

  2. Change in physical activity behaviour [ Time Frame: up to 12 months ]
    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.

  3. Anthropometry [ Time Frame: up to 12 months ]
    Weight (kg) and height (cm) will be combined to report BMI in kg/m^2

  4. Body composition [ Time Frame: up to 12 months ]
    Fat Mass and Fat Free Mass via Bodpod measurement

  5. Energy Expenditure [ Time Frame: up to 6 months ]
    Energy expenditure as measured with indirect calorimetrie

  6. Screentime [ Time Frame: up to 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 BOOSTH game)

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 (children who are attending COACH Sports lessons will be excluded)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435575


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Study Chair: Anita Vreugdenhil, Dr Maastricht University Medical Center
Additional Information:
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03435575    
Other Study ID Numbers: NL61033.000.17
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
physical activity
serious game
childhood obesity
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms