NCT03440580

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
713

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

August 17, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

January 30, 2018

Last Update Submit

September 2, 2020

Conditions

Keywords

physical activityserious gameschool interventionchildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • change in step count

    up to twelve months

  • change in physical activity behaviour

    up to twelve months

  • BMI-z score

    up to twelve months

  • motivation towards physical activity

    up to twelve months (measurement at baseline,3-, 6- and 12 months)

  • screen-time

    up to twelve months (measurement at baseline,3-, 6- and 12 months)

  • +6 more secondary outcomes

Other Outcomes (3)

  • Comprehensive General Parenting Questionnaire

    up to twelve months (measurement at baseline and 6 months)

  • parenting practices questionnaire

    up to twelve months (measurement at baseline and 6 months)

  • Process evaluation

    up to 6 months (measurement at 3- and 6 months)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

The intervention school will receive the BOOSTH intervention: Boosth activity tracker, Boosth sync app, Boosht game app

Device: BOOSTH

control group

NO INTERVENTION

The control school will receive the standard curriculum. After the study is finished the children of the control school will receive the Boosth product

Interventions

BOOSTHDEVICE

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.

Intervention

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Motor ActivityChild Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Anita Vreugdenhil, Dr

    Maastricht University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Schools will be randomized into intervention or control schools. Randomization will be done by an independent researcher. After the randomization, the intervention school receives the BOOSTH intervention. The control school receives BOOSTH after the study is finished.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 22, 2018

Study Start

August 17, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations