NCT03435575

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

November 9, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

3.1 years

First QC Date

January 29, 2018

Last Update Submit

October 1, 2021

Conditions

Physical ActivitySerious GameChildhood ObesityOverweight and Obesity

Keywords

physical activityserious gamechildhood obesity

Outcome Measures

Primary Outcomes (1)

  • change in moderate to vigorous physical activity (min/day)

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

    1 week weartime at baseline, 3, 6 and 12 months

Secondary Outcomes (6)

  • Change in step count

    up to 6 months

  • Change in physical activity behaviour

    up to 12 months

  • Anthropometry

    up to 12 months

  • Body composition

    up to 12 months

  • Energy Expenditure

    up to 6 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Device: Boosth

Control group

NO INTERVENTION

Standard care

Interventions

BoosthDEVICE

Boosth activity tracker which measures steps

Intervention group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Motor ActivityPediatric ObesityOverweightObesity

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention and control group parallel
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 19, 2018

Study Start

November 9, 2017

Primary Completion

December 1, 2020

Study Completion

September 1, 2021

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)