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RecruitingNCT06058325Updated Oct 4, 2023

Healthy School Lunches at Primary Schools in Rotterdam

An interventional study of Healthy school lunch in Healthy, sponsored by Erasmus Medical Center. Recruiting at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,100
Allocation
Randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy lunch
  • Diet
  • Children
  • School
  • Effectivity
  • Feasibility
03

In context

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • The non-compliance of the inclusion criteria will be considered as exclusion criteria.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
1,100 participants (estimated)

Study arms

  • No intervention
    Control group

    Students will bring their own lunch box in the control period.

  • Experimental
    Intervention group

    Students will get a healthy lunch at school in the intervention period.

    Other: Healthy school lunch

Interventions

  • OtherHealthy school lunch

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

Secondary outcomes

  1. 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.

    Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

  2. 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.

    Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

  3. 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

    Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

  4. 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.

    Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

  5. 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.

    Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

  6. 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

    Time frame: During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline

  7. 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.

    Time frame: During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline

Other outcomes

  1. Demographic variables - assessed by a questionnaire

    age, gender, country of birth

    Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

  2. Type of dietary requirement(s) - assessed by a questionnaire

    The kind and amount of dietary requirements will be collected by using a self-reported question. Descriptives will be presented.

    Time frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

  3. Feasibility data on implementation and sustainability - assessed by a questionnaire

    Feasibility data on implementation and sustainability will be collected via self-reported questions constructed by the research team. Questions will focus on implementation, organization, time investment, sustainability. Open answers will be analyzed qualitatively.

    Time frame: Every month during academic year 2023-2024: baseline/1 month/2 months/ 3 months/ 4 months/ 5 months/ 6 months/ 7 months/ 8 months/ 9 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 34579117 ↗
  • van 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 32398052 ↗

Individual participant data

Plan to share: Undecided — A data sharing statement will be finalized when known which percentage of participants consent for sharing data outside of our own organization.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06058325
Lead sponsor
Erasmus Medical Center
Responsible party
Wilma Jansen (Principal Investigator, Erasmus Medical Center) — Principal investigator
First posted
Sep 28, 2023
Start date
Sep 1, 2023
Primary completion
Jul 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Oct 4, 2023

Study contacts

Wilma Jansen, Dr. ir.
Contact
w.jansen.1@erasmusmc.nl
+31107038460
Annemieke Wargers, Msc
Contact
a.wargers@erasmusmc.nl

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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