NCT06073236

Brief Summary

Previous research focusing on preschoolers' healthy behaviors looked at developing interventions for separate behaviors, such as physical activity and sedentary behavior. Currently, there is a shift in research towards focusing on an integrated approach regarding the behaviors conducted in a 24-hour day, since targeting multiple behaviors is more effective. Activities in a 24-hour day consist of physical activity, sedentary behavior and sleep. Only very few Belgian preschoolers (10%) meet the guidelines regarding a healthy 24-hour day. Therefore, interventions focusing on all three behaviors with an integrated approach are needed. Since preschool children spend most of their time at school and at home, and engage in playbased learning in those settings, this project will develop and evaluate an intervention focusing on those 24-hour behaviors both at school and at home. The aim of the intervention is to increase the percentage of preschoolers that comply with the guidelines regarding a 24-hour day. Within the project, we will work closely together with both preschoolers' teachers and parents to develop and create the intervention, framed within the Intervention Mapping protocol. The intervention will be evaluated through a cluster randomized controlled trial, using a pretest, posttest and follow-up. Preschoolers' physical activity, sedentary behavior and sleep will be measured using an objective measurement device (accelerometer).

Trial Health

43
At Risk

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 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

3.1 years

First QC Date

December 20, 2022

Last Update Submit

October 3, 2023

Conditions

Keywords

24-hour movement behavioursbehavioural change interventionpreschoolers

Outcome Measures

Primary Outcomes (3)

  • Compliance with 24-hour movement behaviour guidelines

    Compliance with 24-hour movement behaviour guidelines

    Pretest (before intervention)

  • Compliance with 24-hour movement behaviour guidelines

    Compliance with 24-hour movement behaviour guidelines

    posttest (after intervention = 6 months after pretest)

  • Compliance with 24-hour movement behaviour guidelines

    Compliance with 24-hour movement behaviour guidelines

    Follow-up (6 months after posttest)

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive what came out of the co-creation sessions with preschoolers' teachers and parents.

Behavioral: The healthy day-project

Control group

NO INTERVENTION

No intervention will be given in the control group, but they will receive the intervention after follow-up. Afterwards, teachers and parents can keep the intervention materials as an incentive.

Interventions

The content of the intervention will be based on what comes out of the cocreation sessions, which means that it is not yet possible to know what the intervention will exactly consist of. The idea is to compile two co-creation groups, both consisting of preschool teachers and preschoolers' parents. Within both co-creation groups, feasible and easy-to-use strategies to implement both at preschool and at home embedded within preschoolers' play-based learning will be the goal. Both co-creation groups will investigate and develop ways to incorporate play-based learning within health promotion throughout the day at home and at preschool.

Intervention group

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • preschoolers aged 3-5 years attending participating preschools

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University, Department of Rehabilitation Sciences

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marieke De Craemer, PhD

    University Ghent

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Parents of preschoolers in the intervention region are aware that they are taking part in a health promoting intervention
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial (preschools are unit of randomization) with an intervention and a control including a pretest (T0), a posttest (T1) and a follow-up (T2)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2022

First Posted

October 10, 2023

Study Start

July 1, 2021

Primary Completion

July 30, 2024

Study Completion

August 30, 2024

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations