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BOOSTH: Serious Gaming in Combination With Physical Activity Promotion

Primary Purpose

Physical Activity, Serious Game, Childhood Obesity

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Boosth
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Activity focused on measuring physical activity, serious game, childhood obesity

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Children in the intervention group will receive Boosth: Boosth activity tracker, Boosth syncc app and Boosth game app

Standard care

Outcomes

Primary Outcome Measures

change in moderate to vigorous physical activity (min/day)
moderate to vigorous physical activity (min/day) as measured with the Actigraph accelerometer

Secondary Outcome Measures

Change in step count
Daily step count via Boosth activity tracker
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.
Anthropometry
Weight (kg) and height (cm) will be combined to report BMI in kg/m^2
Body composition
Fat Mass and Fat Free Mass via Bodpod measurement
Energy Expenditure
Energy expenditure as measured with indirect calorimetrie
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.

Full Information

First Posted
January 29, 2018
Last Updated
October 1, 2021
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03435575
Brief Title
BOOSTH: Serious Gaming in Combination With Physical Activity Promotion
Official Title
BOOSTH: Serious Gaming in Combination With Physical Activity Promotion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Inclusion rate not reached and due to the COVID-19 pandemic not enough follow up measurements of the included participants.
Study Start Date
November 9, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Serious Game, Childhood Obesity, Overweight and Obesity
Keywords
physical activity, serious game, childhood obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Children in the intervention group will receive Boosth: Boosth activity tracker, Boosth syncc app and Boosth game app
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Device
Intervention Name(s)
Boosth
Intervention Description
Boosth activity tracker which measures steps
Primary Outcome Measure Information:
Title
change in moderate to vigorous physical activity (min/day)
Description
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
Secondary Outcome Measure Information:
Title
Change in step count
Description
Daily step count via Boosth activity tracker
Time Frame
up to 6 months
Title
Change in physical activity behaviour
Description
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
Title
Anthropometry
Description
Weight (kg) and height (cm) will be combined to report BMI in kg/m^2
Time Frame
up to 12 months
Title
Body composition
Description
Fat Mass and Fat Free Mass via Bodpod measurement
Time Frame
up to 12 months
Title
Energy Expenditure
Description
Energy expenditure as measured with indirect calorimetrie
Time Frame
up to 6 months
Title
Screentime
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Vreugdenhil, Dr
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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BOOSTH: Serious Gaming in Combination With Physical Activity Promotion

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