NCT06171191

Brief Summary

In 2019, the World Health Organization established new guidelines for physical activity, sedentary screen time, and sleep for children under 5 years old. Unfortunately, only a few (6%) of preschoolers in Flanders, Belgium, adhere to these guidelines. The aim of this study is to test a health program developed to optimize 24-hour behaviors in preschoolers and encourage more children to follow the guidelines. The program was created using the Intervention Mapping Protocol in collaboration with parents. It consists of seven sessions for parents and preschoolers, providing strategies to encourage compliance with the guidelines. The program's effectiveness will be evaluated through a randomized controlled trial, with the intervention group attending the sessions and the control group receiving the intervention materials at the end of the study.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

December 6, 2023

Last Update Submit

February 22, 2024

Conditions

Keywords

24-hour movement behaviorphysical activitysedentary behaviorscreen timesleeppreschoolerparenting

Outcome Measures

Primary Outcomes (1)

  • 24-hour movement behaviour: physical activity, sedentary behaviour and sleep

    These behaviours will be assessed with accelerometers (GT3X+), To differentiate sedentary behavior from light physical activity and light physical activity from moderate to vigourous physical activity cut-points of 25 and 420 counts/15 seconds will be used respectively (Evenson et al., 2008; Pate et al., 2006)

    Results in October 2024

Secondary Outcomes (2)

  • Parenting practices

    Results in October 2024

  • Process

    Results in October 2024

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group receives intervention between prétest and posttest. Three months after posttest they undergo a follow-up test

Behavioral: Move-ARound And Get Active

Control group

OTHER

Waiting group. Control group receives intervention after all test (prétest, posttest and follow-up test)

Behavioral: Move-ARound And Get Active

Interventions

The intervention consists of seven sessions for parents and preschoolers, providing strategies to encourage compliance with the 24-hour movement behavior guidelines for preschoolers of the World Health Organisation.

Also known as: MARGA
Control groupIntervention group

Eligibility Criteria

Age30 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Preschoolers between 2,5 to 6 years
  • One parent per preschooler
  • Parent needs to be able to understand, speak, read and write Dutch
  • Child needs to be able to understand Dutch
  • Child needs to be able to wear accelerometer
  • Child needs to by mentally and physically able to comply with the 24-hour movement behavior guidelines
  • Parent needs to be mentally able to complete the testing and intervention

You may not qualify if:

  • Participants will be excluded form analyses when incomplete data required to answer the research question

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Onze-Lieve-Vrouwenziekenhuis Campus Aalst

Aalst, East-Flanders, 9300, Belgium

RECRUITING

AZ Alma

Eeklo, East-Flanders, 9900, Belgium

RECRUITING

AZ Jan Palfijn

Ghent, East-Flanders, 9000, Belgium

RECRUITING

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Related Publications (1)

  • Decraene M, Miatke A, Dumuid D, Cardon G, Verloigne M, De Bruyne R, Verbestel V, De Craemer M. Optimising 24-Hour movement behaviours in preschoolers through parenting practices: an evidence-based intervention study. Int J Behav Nutr Phys Act. 2025 Dec 12. doi: 10.1186/s12966-025-01863-z. Online ahead of print.

MeSH Terms

Conditions

Child BehaviorPediatric ObesitySedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ruth De Bruyne, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marga Decraene, MSc

CONTACT

Marieke De Craemer, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised controlled trial. Prétest, posttest, follow-up test design. Intervention group receives intervention in between prétest en posttest. Control group receives intervention after follow-up
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

July 27, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations