HealthyNCT06058325
Healthy School Lunches at Primary Schools in Rotterdam
A study testing Healthy school lunch in people with Healthy, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Obesity in children is increasing over the last decades and the majority of children in Europe fails to have a healthy diet. In the Netherlands, the majority of primary schools do not provide a (healthy) school lunch. However, previous research shows some positive effects. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Healthy school lunch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2023to Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Schools: Schools will be included if they are a LF! school, have a high deprivation score and ≥ 20% overweight/obesity, and are willing to participate in the project irrespective of starting in the intervention or control period. Schools should be willing to facilitate retrieving consent from parents and should provide students time to complete the questionnaire during school hours. They should also be willing to participate in a co-creation event, in which the lunch concept for their school will be designed together with school staff, parents, and children. Schools should be willing to facilitate the implementation of a healthy school lunch and should not provide any extra activities regarding healthy school lunches during the control period.
- Children: All children of the participating schools will be eligible to receive a healthy school lunch, also if parents do not provide informed consent for the research project. Data will be gathered for all children for whom informed consent is provided for participating in the data gathering. Informed consent must be signed by the parents of children who are allowed to participate in the research activities (observations and questionnaires) in the school. Additionally, when children are 12 years or older they have to sign an informed consent themselves.
- Parents: All parents with children in the participating schools will be included into the project to complete questionnaires. Informed consent must be signed by the parent.
- Teachers: All teachers in participating will be included into the project to complete questionnaires. Informed consent must be signed by the teacher.
Who cannot join
- The non-compliance of the inclusion criteria will be considered as exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Annemieke Wargers, Msc contact
Netherlands1 site, 1 recruiting
- Recruiting
Department of Public Health, Erasmus MC University Medical Center
Rotterdam
Wilma Jansen, w.jansen.1@erasmusmc.nl
Annemieke Wargers, a.wargers@erasmusmc.nl
About this study
Official title: Healthy School Lunch at Primary Schools in Rotterdam, the Netherlands
Obesity in children is increasing over the last decades and the majority of children in Europe fails to have a healthy diet. In the Netherlands, the majority of primary schools do not provide a (healthy) school lunch. However, previous research shows some positive effects. Within the current study the investigators want to implement healthy school lunches in the city of Rotterdam, a city with a very diverse youth population. The main objective of the healthy school lunch project is to evaluate the effectiveness and feasibility of providing healthy school lunches.
This is a prospective, single center, intervention study using a cross-over design with 3 measurement moments to collect data on effects and feasibility. Additional feasibility data will be collected throughout the study via questionnaires for teachers.
Read more
The study population is derived from primary schools participating in the "Enjoy Being Fit!" program in the city of Rotterdam. Children (4-12 years old) from these schools are eligible to participate in this study. Children from participating primary schools will take part in observations and complete questionnaires (only grade 5 to 8). Parents and teachers will complete questionnaires.
Together with individual schools and stakeholders a healthy school-lunch concept will be developed and implemented for half a school year. Data will be collected on three time points during the school year.
Questionnaires for children and parents will focus on dietary behaviour/food intake, taste preferences, perceived health, and the satisfaction with the healthy school lunch (also for teachers). Atmosphere in the class during lessons and during lunch will be measured in questionnaires for children and teachers. The questionnaire for parents also focuses on affordability of a healthy school lunch. Observation forms will be used to score on one day what snack and lunch children bring to/get at school.
- Conditions
- Healthy
- Being tested
- Healthy school lunch
- Keywords
- Healthy lunch, Diet, Children, School, Effectivity, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy school lunchOther
The healthy school lunch will be co-created together with school staff, parents, and children, and should be healthy according guidelines of the Dutch nutrition center.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Students will bring their own lunch box in the control period. |
| Intervention group | Experimental | Students will get a healthy lunch at school in the intervention period. Receives: Other: Healthy school lunch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary content of children's lunches - assessed by an observation form
Observation of type and amount of bread, topping, drinks, fruits, vegetables, and other food products
Measured: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Secondary outcomes (7)
General dietary behaviour of children - assessed by a questionnaire
(consumption of breakfast, fruit, vegetable, water, sugar sweetened beverages -children and parents)
Questions adapted from the GGD (Dutch municipal health service) health monitor.
Measured: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Perceived health of children - assessed by a questionnaire
Questions adapted from the GGD (Dutch municipal health service) health monitor: general health, in past week, in past 3 months.
Measured: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Taste preferences of children - assessed by a questionnaire
Self-reported questions on taste of different fruits (n=12) and vegetables (n=16).
Questions adapted from the Healthy Primary School of the Future study
Measured: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Concentration in class - assessed by a questionnaire
Self-reported question on the ability to concentrate in class. For children reported on individual level. For teachers reported on class level.
Measured: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Atmosphere in class - assessed by a questionnaire
Self-reported questions on the atmosphere in class. For children reported on individual level. For teachers reported on class level.
Measured: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Financial situation of parents - assessed by a questionnaire
Questions adapted from the GGD (Dutch municipal health service) health monitor: difficulties making ends meet \& inability to do things due to lack of money
Measured: During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline
Satisfaction of the healthy school lunch - assessed by a questionnaire
Self-reported questions partly adapted from the Healthy School Lunch study and partly constructed by the research team. Satisfaction questions focused on: participation, content of lunch, organization, reasons to participate, continuation.
Descriptives will be presented.
Measured: During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Sep 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will use a cross-over design, which means participating schools have both a control and intervention period during academic year 2023-2024. Schools will be randomized into group A or B, starting with either an intervention or control period. During the intervention period, schools will organize a healthy lunch for all children during four days a week for a duration of half an academic year (approximately 18 weeks). During the control period, children will bring their own lunch box.
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilma Jansen, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058325
- Sponsor's protocol ID
- 10115
- Status last verified
- Oct 2023
- First submitted
- 31 Aug 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A data sharing statement will be finalized when known which percentage of participants consent for sharing data outside of our own organization.
Publications
Hahnraths MTH, Willeboordse M, van Assema P, Winkens B, van Schayck CP. The Effects of the Healthy Primary School of the Future on Children's Fruit and Vegetable Preferences, Familiarity and Intake. Nutrients. 2021 Sep 17;13(9):3241. doi: 10.3390/nu13093241.
PubMed 34579117van Kleef E, Rongen FC, Vingerhoeds MH, Dijkstra SC, Seidell JC. Improving dietary intake during lunch through the provision of a healthy school lunch at Dutch primary schools: design of a pretest-posttest effectiveness study. BMC Public Health. 2020 May 12;20(1):662. doi: 10.1186/s12889-020-08807-1.
PubMed 32398052Wargers A, Polychronakis K, Nieboer D, Raat H, Jansen W. Co-creation and implementation of a healthy lunch at Dutch primary schools in disadvantaged neighbourhoods: design of a cluster randomised cross-over effectiveness study. BMJ Open. 2024 Oct 16;14(10):e083534. doi: 10.1136/bmjopen-2023-083534.
PubMed 39414278
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy School Lunch at Primary Schools in Rotterdam, the Netherlands
- ClinicalTrials.gov ID
- NCT06058325
- Acronym / sponsor ID
- 10115
- Conditions
- Healthy
- Keywords
- Healthy lunch, Diet, Children, School, Effectivity, Feasibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 28 Sep 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.
Obesity in children is increasing over the last decades and the majority of children in Europe fails to have a healthy diet. In the Netherlands, the majority of primary schools do not provide a (healthy) school lunch. However, previous research shows some positive effects. Within the current study the investigators want to implement healthy school lunches in the city of Rotterdam, a city with a very diverse youth population. The main objective of the healthy school lunch project is to evaluate the effectiveness and feasibility of providing healthy school lunches.
This is a prospective, single center, intervention study using a cross-over design with 3 measurement moments to collect data on effects and feasibility. Additional feasibility data will be collected throughout the study via questionnaires for teachers.
The study population is derived from primary schools participating in the "Enjoy Being Fit!" program in the city of Rotterdam. Children (4-12 years old) from these schools are eligible to participate in this study. Children from participating primary schools will take part in observations and complete questionnaires (only grade 5 to 8). Parents and teachers will complete questionnaires.
Together with individual schools and stakeholders a healthy school-lunch concept will be developed and implemented for half a school year. Data will be collected on three time points during the school year.
Questionnaires for children and parents will focus on dietary behaviour/food intake, taste preferences, perceived health, and the satisfaction with the healthy school lunch (also for teachers). Atmosphere in the class during lessons and during lunch will be measured in questionnaires for children and teachers. The questionnaire for parents also focuses on affordability of a healthy school lunch. Observation forms will be used to score on one day what snack and lunch children bring to/get at school.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will use a cross-over design, which means participating schools have both a control and intervention period during academic year 2023-2024. Schools will be randomized into group A or B, starting with either an intervention or control period. During the intervention period, schools will organize a healthy lunch for all children during four days a week for a duration of half an academic year (approximately 18 weeks). During the control period, children will bring their own lunch box.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Students will bring their own lunch box in the control period. |
| Intervention group | Experimental | Other: Healthy school lunchStudents will get a healthy lunch at school in the intervention period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Schools: Schools will be included if they are a LF! school, have a high deprivation score and ≥ 20% overweight/obesity, and are willing to participate in the project irrespective of starting in the intervention or control period. Schools should be willing to facilitate retrieving consent from parents and should provide students time to complete the questionnaire during school hours. They should also be willing to participate in a co-creation event, in which the lunch concept for their school will be designed together with school staff, parents, and children. Schools should be willing to facilitate the implementation of a healthy school lunch and should not provide any extra activities regarding healthy school lunches during the control period.
- Children: All children of the participating schools will be eligible to receive a healthy school lunch, also if parents do not provide informed consent for the research project. Data will be gathered for all children for whom informed consent is provided for participating in the data gathering. Informed consent must be signed by the parents of children who are allowed to participate in the research activities (observations and questionnaires) in the school. Additionally, when children are 12 years or older they have to sign an informed consent themselves.
- Parents: All parents with children in the participating schools will be included into the project to complete questionnaires. Informed consent must be signed by the parent.
- Teachers: All teachers in participating will be included into the project to complete questionnaires. Informed consent must be signed by the teacher.
Key exclusion criteria (1 listed)
- The non-compliance of the inclusion criteria will be considered as exclusion criteria.
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 |
|---|---|---|
| Healthy school lunchThe healthy school lunch will be co-created together with school staff, parents, and children, and should be healthy according guidelines of the Dutch nutrition center. | Other | Intervention group |
Primary outcome
Dietary content of children's lunches - assessed by an observation form
Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Observation of type and amount of bread, topping, drinks, fruits, vegetables, and other food products
7 secondary outcomes
General dietary behaviour of children - assessed by a questionnaire
Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Perceived health of children - assessed by a questionnaire
Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Taste preferences of children - assessed by a questionnaire
Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Concentration in class - assessed by a questionnaire
Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Atmosphere in class - assessed by a questionnaire
Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Financial situation of parents - assessed by a questionnaire
Time frame: During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline
Satisfaction of the healthy school lunch - assessed by a questionnaire
Time frame: During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Background: PubMed 34579117Hahnraths MTH, Willeboordse M, van Assema P, Winkens B, van Schayck CP. The Effects of the Healthy Primary School of the Future on Children's Fruit and Vegetable Preferences, Familiarity and Intake. Nutrients. 2021 Sep 17;13(9):3241. doi: 10.3390/nu13093241.
- Background: PubMed 32398052van Kleef E, Rongen FC, Vingerhoeds MH, Dijkstra SC, Seidell JC. Improving dietary intake during lunch through the provision of a healthy school lunch at Dutch primary schools: design of a pretest-posttest effectiveness study. BMC Public Health. 2020 May 12;20(1):662. doi: 10.1186/s12889-020-08807-1.
- Derived from this study: PubMed 39414278Wargers A, Polychronakis K, Nieboer D, Raat H, Jansen W. Co-creation and implementation of a healthy lunch at Dutch primary schools in disadvantaged neighbourhoods: design of a cluster randomised cross-over effectiveness study. BMJ Open. 2024 Oct 16;14(10):e083534. doi: 10.1136/bmjopen-2023-083534.
- Individual participant dataSharing planned: Undecided. A data sharing statement will be finalized when known which percentage of participants consent for sharing data outside of our own organization.
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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.
Annemieke Wargers, Msc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy school lunch in people with Healthy, run by Erasmus Medical Center at 1 site in Netherlands.
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 4 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 4 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 Netherlands. 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 Wilma Jansen, Dr. ir. (+31107038460, w.jansen.1@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary content of children's lunches - assessed by an observation form (time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks). 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 NCT06058325, which also lists 3 linked publications.
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 4 Oct 2023.