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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Marieke De Craemer, PhD contact
Belgium4 sites, 4 recruiting
- 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
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:
- Do more preschoolers comply with the World Health Organization 24-hour movement behavior guidelines?
- 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:
- To analyze the intervention effect on parenting within the self-determination theory: Do parents provide more structure, autonomy support, and positive involvement?
- 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.
- Conditions
- Parents, Child Behavior, Child Obesity, Physical Inactivity, Sedentary Behavior, Sedentary Time
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention 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 group | Other | Waiting 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.
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)
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
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.
- First posted14 Dec 2023
- Study start27 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Onze Lieve Vrouwziekenhuis Aalst, AZ Jan Palfijn Gent, AZ Alma, Algemeen Ziekenhuis Maria Middelares
- Responsible party
- Sponsor
- Investigators
- Ruth De Bruyne, PhD, Principal investigator, University Hospital, Ghent
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move ARound And Get Active: an Intervention to Optimize 24-hour Movement Behaviours in Preschoolers
- ClinicalTrials.gov ID
- NCT06171191
- Acronym / sponsor ID
- MARGA / ONZ-2023-0229
- Conditions
- Parents, Child Behavior, Child Obesity, Physical Inactivity, Sedentary Behavior, Sedentary Time
- Keywords
- 24-hour movement behavior, physical activity, sedentary behavior, screen time, sleep, preschooler, parenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Onze Lieve Vrouwziekenhuis Aalst, AZ Jan Palfijn Gent, AZ Alma, Algemeen Ziekenhuis Maria Middelares
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Do more preschoolers comply with the World Health Organization 24-hour movement behavior guidelines?
- 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:
- To analyze the intervention effect on parenting within the self-determination theory: Do parents provide more structure, autonomy support, and positive involvement?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Move-ARound And Get ActiveIntervention group receives intervention between prétest and posttest. Three months after posttest they undergo a follow-up test |
| Control group | Other | Behavioral: Move-ARound And Get ActiveWaiting group. Control group receives intervention after all test (prétest, posttest and follow-up test) |
Who may qualify
- Ages
- 30 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Are clear based on the inclusion criteria
- Participants will be excluded form analyses when incomplete data required to answer the research question
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Move-ARound And Get ActiveAlso: MARGAThe 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. | Behavioural | Control group, Intervention group |
Primary outcome
24-hour movement behaviour: physical activity, sedentary behaviour and sleep
Time frame: Results in October 2024
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)
2 secondary outcomes
Parenting practices
Time frame: Results in October 2024
Process
Time frame: Results in October 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 41388547Decraene 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.
- Individual participant dataSharing planned: Undecided. This is undecided. There is no further plan available
Related trials for Parents
Active, not recruiting
High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
HPV Vaccination
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marieke De Craemer, PhD contact
Ruth De Bruyne, PhD principal investigator
University Hospital, Ghent
4 sites in 1 country: see every site and its status.
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.