Health BehaviorNCT06073236
A Co-creational Intervention to Engage Preschoolers in Healthy Movement Behaviors
A study testing The healthy day-project in people with Health Behavior, run by University Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- The healthy day-project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2021to 30 Aug 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preschoolers aged 3-5 years attending participating preschools
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University, Department of Rehabilitation Sciences
Ghent, 9000
About this study
Official title: The Use of Co-creation to Develop an Intervention to Engage Preschoolers in Healthy Movement Behaviors for Life: the Healthy Day Project.
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).
Read the detailed description
Research has shown that sufficient physical activity, limiting sedentary behavior (i.e. sitting or lying down), and adequate sleep yield health benefits in preschoolers. This resulted in separate health guidelines for preschoolers that recommended 180 minutes of daily physical activity, spending no more than 1 hour per day sedentary in front of a screen, and sleeping at least 10h-13h per day (naps during the day included). However, research has shown that these 3 behaviors are related to each other within the time frame of a 24-hour day.
A day consists of exactly 24 hours that are filled with activities that can be categorized as physical activity, sedentary behavior or sleep. This implies that a change in one of these behaviors (e.g. more physical activity) causes a change in the time that can be spent on (one of) the other two behaviors (e.g. less sedentary and/or less sleep). Recent research has shown additional health benefits when preschoolers meet more than one of the above guidelines. For example, more positive health effects are obtained when sedentary behavior is reduced and replaced by more physical activity while maintaining the hours of sleep per day. These findings resulted in the integrated 24-hour guidelines for physical activity behavior distributed by the World Health Organization in 2019. According to these guidelines, a healthy day for preschoolers consists of (1) at least 180 minutes of physical activity, 60 minutes of which are at moderate to high intensity, (2) a maximum of 1 hour of sedentary screen time, and (3) 10 to 13 hours of good quality sleep. The greatest health effect is obtained when children meet all three guidelines.
Evidence showed that only 1 in 10 Belgian preschoolers meet the 24-hour guidelines for physical activity. Therefore, there is currently a need to develop interventions that focus on the 3 behaviors simultaneously. In the past, interventions mainly focused on one or two of these behaviors separately and never aimed for an optimal combination of these 3 behaviors. The present project will therefore develop, implement and evaluate an intervention to promote these 3 behaviors through the home and school environment. The goal of the intervention is to increase the number of preschoolers who achieve the integrated 24-hour movement behavior guidelines per day. The intervention will be developed based on the Intervention Mapping protocol, a widely used protocol to develop evidence based behavior change interventions. To increase the chance of developing a successful intervention, the intervention will be developed by using a co-creational approach. This is a specific form of collaboration where stakeholders are involved in the developmental process and the end result of the intervention. Important stakeholders for the development of preschoolers in this project are teachers and parents. Co-creation can only be successful if there is equality between the participants, reciprocity and if is conducted within an atmosphere of openness and confidence. In order for these conditions to be met, the co-creation process will be supervised by a researcher. Two co-creation groups will be formed that include both parents and teachers. Both groups will be composed of 3 to 4 preschool teachers and 3 to 4 parents of 3- to 5-year-old preschoolers. The co-creation groups will go through the first four steps of the Intervention Mapping protocol together with the researcher. The results of the co-creation will be compared after each session with the goal of reaching a consensus on the final intervention in both groups at the end of the process. The intervention will be composed of easily usable and achievable intervention strategies (e.g. storytelling, games,...) aimed at the game-based learning of preschoolers in the home and school environments.
The second objective of this research project is the evaluation of this newly developed, theory-based intervention. The intervention will be tested via a cluster randomized controlled trial (RCT) design (as preschools will be the unit of randomization), including an intervention and control group. The evaluation of the intervention will consist of an effect evaluation evaluation. We hypothesize that the intervention will lead to a higher percentage of preschool children complying with these guidelines. The design of the RCT (pretest-posttest-follow-up, intervention and control group) will allow us to measure the evolution over time as a result of the intervention.
- Conditions
- Health Behavior
- Being tested
- The healthy day-project
- Keywords
- 24-hour movement behaviours, behavioural change intervention, preschoolers
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The healthy day-projectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive what came out of the co-creation sessions with preschoolers' teachers and parents. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with 24-hour movement behaviour guidelines
Compliance with 24-hour movement behaviour guidelines
Measured: Pretest (before intervention)
Compliance with 24-hour movement behaviour guidelines
Compliance with 24-hour movement behaviour guidelines
Measured: posttest (after intervention = 6 months after pretest)
Compliance with 24-hour movement behaviour guidelines
Compliance with 24-hour movement behaviour guidelines
Measured: Follow-up (6 months after posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jul 2021
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marieke De Craemer, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073236
- Sponsor's protocol ID
- BC-08724
- Status last verified
- Oct 2023
- First submitted
- 20 Dec 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Co-creation to Develop an Intervention to Engage Preschoolers in Healthy Movement Behaviors for Life: the Healthy Day Project.
- ClinicalTrials.gov ID
- NCT06073236
- Acronym / sponsor ID
- BC-08724
- Conditions
- Health Behavior
- Keywords
- 24-hour movement behaviours, behavioural change intervention, preschoolers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 10 Oct 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.
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).
Detailed description
Research has shown that sufficient physical activity, limiting sedentary behavior (i.e. sitting or lying down), and adequate sleep yield health benefits in preschoolers. This resulted in separate health guidelines for preschoolers that recommended 180 minutes of daily physical activity, spending no more than 1 hour per day sedentary in front of a screen, and sleeping at least 10h-13h per day (naps during the day included). However, research has shown that these 3 behaviors are related to each other within the time frame of a 24-hour day.
A day consists of exactly 24 hours that are filled with activities that can be categorized as physical activity, sedentary behavior or sleep. This implies that a change in one of these behaviors (e.g. more physical activity) causes a change in the time that can be spent on (one of) the other two behaviors (e.g. less sedentary and/or less sleep). Recent research has shown additional health benefits when preschoolers meet more than one of the above guidelines. For example, more positive health effects are obtained when sedentary behavior is reduced and replaced by more physical activity while maintaining the hours of sleep per day. These findings resulted in the integrated 24-hour guidelines for physical activity behavior distributed by the World Health Organization in 2019. According to these guidelines, a healthy day for preschoolers consists of (1) at least 180 minutes of physical activity, 60 minutes of which are at moderate to high intensity, (2) a maximum of 1 hour of sedentary screen time, and (3) 10 to 13 hours of good quality sleep. The greatest health effect is obtained when children meet all three guidelines.
Evidence showed that only 1 in 10 Belgian preschoolers meet the 24-hour guidelines for physical activity. Therefore, there is currently a need to develop interventions that focus on the 3 behaviors simultaneously. In the past, interventions mainly focused on one or two of these behaviors separately and never aimed for an optimal combination of these 3 behaviors. The present project will therefore develop, implement and evaluate an intervention to promote these 3 behaviors through the home and school environment. The goal of the intervention is to increase the number of preschoolers who achieve the integrated 24-hour movement behavior guidelines per day. The intervention will be developed based on the Intervention Mapping protocol, a widely used protocol to develop evidence based behavior change interventions. To increase the chance of developing a successful intervention, the intervention will be developed by using a co-creational approach. This is a specific form of collaboration where stakeholders are involved in the developmental process and the end result of the intervention. Important stakeholders for the development of preschoolers in this project are teachers and parents. Co-creation can only be successful if there is equality between the participants, reciprocity and if is conducted within an atmosphere of openness and confidence. In order for these conditions to be met, the co-creation process will be supervised by a researcher. Two co-creation groups will be formed that include both parents and teachers. Both groups will be composed of 3 to 4 preschool teachers and 3 to 4 parents of 3- to 5-year-old preschoolers. The co-creation groups will go through the first four steps of the Intervention Mapping protocol together with the researcher. The results of the co-creation will be compared after each session with the goal of reaching a consensus on the final intervention in both groups at the end of the process. The intervention will be composed of easily usable and achievable intervention strategies (e.g. storytelling, games,...) aimed at the game-based learning of preschoolers in the home and school environments.
The second objective of this research project is the evaluation of this newly developed, theory-based intervention. The intervention will be tested via a cluster randomized controlled trial (RCT) design (as preschools will be the unit of randomization), including an intervention and control group. The evaluation of the intervention will consist of an effect evaluation evaluation. We hypothesize that the intervention will lead to a higher percentage of preschool children complying with these guidelines. The design of the RCT (pretest-posttest-follow-up, intervention and control group) will allow us to measure the evolution over time as a result of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: The healthy day-projectThe intervention group will receive what came out of the co-creation sessions with preschoolers' teachers and parents. |
| 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preschoolers aged 3-5 years attending participating preschools
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| The healthy day-projectThe 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. | Behavioural | Intervention group |
Primary outcome
Compliance with 24-hour movement behaviour guidelines
Time frame: Pretest (before intervention)
Compliance with 24-hour movement behaviour guidelines
Compliance with 24-hour movement behaviour guidelines
Time frame: posttest (after intervention = 6 months after pretest)
Compliance with 24-hour movement behaviour guidelines
Compliance with 24-hour movement behaviour guidelines
Time frame: Follow-up (6 months after posttest)
Compliance with 24-hour movement behaviour guidelines
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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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 study chair
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The healthy day-project in people with Health Behavior, run by University Ghent at 1 site 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 1 inclusion and 1 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with 24-hour movement behaviour guidelines (time frame: Pretest (before intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2023.