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ParentsMARGANCT06171191

Move ARound And Get Active: an Intervention to Optimize 24-hour Movement Behaviours in Preschoolers

A study testing Move-ARound And Get Active in people with Parents and Child Behavior, run by University Hospital, Ghent at 4 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 months to 6 yearsHealthy volunteers can take part
Conditions the study is for
Parents, Child Behavior, Child Obesity
What is being tested?
Move-ARound And Get Active
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesBelgium
Study dates
27 Jul 2023to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 months to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • Are clear based on the inclusion criteria
  • Participants will be excluded form analyses when incomplete data required to answer the research question

Trial locations and contacts

4 sites in 1 country.

Marga Decraene, MSc contact

+32 9 332 26 32

marga.decraene@ugent.be

Marieke De Craemer, PhD contact

marieke.decraemer@ugent.be

Belgium4 sites, 4 recruiting
  • Onze-Lieve-Vrouwenziekenhuis Campus Aalst

    Aalst, East-Flanders, 9300

    Carla Hooft, 053/724960, ethisch.comite@olvz-aalst.be

    Nadine De Neef, 053/724960, ethisch.comite@olvz-aalst.be

    Recruiting
  • AZ Alma

    Eeklo, East-Flanders, 9900

    Muriel Thienpont, 09 310 00 00, muriel.thienpont@azalma.be

    Katrien Vanneste, MSc

    Recruiting
  • AZ Jan Palfijn

    Ghent, East-Flanders, 9000

    Mathijs Vandamme, 09 224 71 11, Mathijs.Vandamme@janpalfijn.be

    Nele Baeck, MSc

    Recruiting
  • University Hospital Ghent

    Ghent, East-Flanders, 9000

    Marieke GM De Craemer, PhD, marieke.decraemer@ugent.be

    Ruth De Bruyne, PhD

    Recruiting

Other trials in Belgium

About this study

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.

Read the detailed description

In 2019, the World Health Organization (WHO) established new guidelines for physical activity, sedentary screen behavior, and sleep in children under 5 years old (WHO, 2019). Unfortunately, only a few (6%) preschoolers in Flanders, Belgium, adhere to these guidelines (De Craemer et al., 2018). The objective of this study is to test a health program developed to optimize 24-hour behaviors in preschoolers and encourage more children to adhere to the guidelines. The program was developed using the Intervention Mapping Protocol, in collaboration with parents (Bartholomew, 2011). The program consists of seven sessions for parents and preschoolers, providing strategies to encourage adherence to the guidelines through parenting skills within the framework of self-determination theory (Di Pasquale et al., 2018). The program will be evaluated through a randomized controlled trial. The intervention group will attend the sessions, while the control group will receive the intervention materials at the end of the study.

Aims:

The primary aim is to analyze the intervention effect on 24-hour movement behaviors:

  1. Do more preschoolers comply with the World Health Organization 24-hour movement behavior guidelines?
  2. Is there an optimal change in the 24-hour composition of preschoolers (i.e., more physical activity, less screen time, and/or more sufficient sleep relative to each other)? The secondary aims are:
  3. To analyze the intervention effect on parenting within the self-determination theory: Do parents provide more structure, autonomy support, and positive involvement?
  4. Process evaluation of the intervention: Describing fidelity, dose delivered, dose received, reach, and context based on Saunders et al. (2005). Patient Recruitment:
  • Group of interest: parents and preschoolers aged 2.5-6 years.
  • Recruitment through care providers
  • Information dissemination through flyers and personal interaction with parents. Active informed consent is required for participation, by signing a informed consent form.
  • Participants are assigned to the intervention or control group based on location. Participants recruited via schools at location X and hospital Y are assigned to the intervention group, while those recruited via schools at location A and hospital B are assigned to the control group.
  • Sample size: max. 200 parent-child dyads Data Collection:
  • Measurements are conducted before, after, and 3 months after the end of the sessions in both the intervention and control groups.
  • Measurements include height, weight, waist and hip circumference of the preschoolers, ActiGraph GT3X+ activity monitoring for both child and parent, a diary filled out by parents to support the activity monitor, and a questionnaire on demographic data and parent-related factors (e.g., parenting skills).
  • At the end of each session, parents in the intervention group complete a process evaluation questionnaire based on the framework of Saunders et al. (2005). The control group completes questions regarding the context at the end of the sessions, following the framework of Saunders et al. (2005), e.g., participation in health interventions. Intervention Session Content: A total of seven sessions are spread over 14 weeks, conducted in groups of 12 parent-child dyads.
  • Session 1: Parent: Information session on 24-hour behavior and parenting skills approached from the self-determination theory. Child: Omnisport (athletics, gymnastics, dance, and/or ball sports).
  • Session 2: Parent and child: Week scheduling.
  • Session 3: Parent: Discussion group on weekly planning. Child: Omnisport (athletics, gymnastics, dance, and/or ball sports). - Session 4: Parent and child: Movement games. - Session 5: Parent and child: Sleep routine. - Session 6: Parent: Discussion group on sleep routine. Child: Omnisport (athletics, gymnastics, dance, and/or ball sports).
  • Session 7: Parent: Information session on sustainable healthy behavior - persistence and dealing with relapse. Child: Omnisport (athletics, gymnastics, dance, and/or ball sports). Sessions involving parents are conducted by the leading PhD student, while omnisport for preschoolers is led by master's students from the Faculty of Medicine and Health Sciences at UGent (e.g., Rehabilitation Sciences, Exercise and Sports Sciences, Health Promotion) under her guidance. Data Management: A Data Management Plan was created using DMPonline.be. Data Analyses: R software will be used for statistical analyses. Participants need complete data for variables included in the analyses relevant to the specific research aim. Outliers with unrealistic values will be checked, and Little's test will assess whether missing data deviates from Missing Completely At Random (MCAR). Logistic regression models will be applied if necessary to explore relationships between missing values and other recorded variables. To analyze intervention effects, multilevel repeated measures will be used with three levels: time, preschooler, organization (kindergartens/hospitals), adjusted for sex, age, socio-economic status, and session group. Compositional data analyses (CoDA) will be applied to analyze the effect on 24-hour composition. Statistical significance will be set at p<0.05.
Being tested
Move-ARound And Get Active
Keywords
24-hour movement behavior, physical activity, sedentary behavior, screen time, sleep, preschooler, parenting
Medical subject headings
Child Behavior, Pediatric Obesity, Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Move-ARound And Get ActiveBehavioural

    Also called MARGA

    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.

Study groups in NCT06171191
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention group receives intervention between prétest and posttest. Three months after posttest they undergo a follow-up test
Receives: Behavioral: Move-ARound And Get Active
Control groupOtherWaiting group. Control group receives intervention after all test (prétest, posttest and follow-up test)
Receives: Behavioral: Move-ARound And Get Active

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Results in October 2024

Secondary outcomes (2)
  1. Parenting practices

    Parenting practices will be assessed within the self-determination theory (Di Pasquale et al., 2018), focusing on providing structure, autonomy support and positive involvement

    Measured: Results in October 2024

  2. Process

    The process of the intervention will be evaluated based on the framework of Saunders et al. (2005): fidelity, dose delivered, dose received, reach and context will by analysed

    Measured: Results in October 2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2023
  2. Study start27 Jul 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06171191
Sponsor's protocol ID
ONZ-2023-0229
Acronym
MARGA
Status last verified
Feb 2024
First submitted
6 Dec 2023
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This is undecided. There is no further plan available

Publications

  • 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;23(1):4. doi: 10.1186/s12966-025-01863-z.

    PubMed 41388547

Questions about this trial

What is this clinical trial studying?

A study testing Move-ARound And Get Active in people with Parents and Child Behavior, run by University Hospital, Ghent at 4 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marga Decraene, MSc (+32 9 332 26 32, marga.decraene@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour movement behaviour: physical activity, sedentary behaviour and sleep (time frame: Results in October 2024). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06171191, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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MARGA Clinical Trial NCT06171191 | AzTrials