Healthy School Lunches at Primary Schools in Rotterdam

October 2, 2023 updated by: Wilma Jansen, Erasmus Medical Center

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

(consumption of breakfast, fruit, vegetable, water, sugar sweetened beverages -children and parents)

Questions adapted from the GGD (Dutch municipal health service) health monitor.

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
Questions adapted from the GGD (Dutch municipal health service) health monitor: general health, in past week, in past 3 months.
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
Self-reported question on the ability to concentrate in class. For children reported on individual level. For teachers reported on class level.
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
Self-reported questions on the atmosphere in class. For children reported on individual level. For teachers reported on class level.
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
Questions adapted from the GGD (Dutch municipal health service) health monitor: difficulties making ends meet & inability to do things due to lack of money
During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline
Taste preferences of children - assessed by a questionnaire
Time Frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

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

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

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.

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic variables - assessed by a questionnaire
Time Frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
age, gender, country of birth
Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Type of dietary requirement(s) - assessed by a questionnaire
Time Frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks

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

Descriptives will be presented.

Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Feasibility data on implementation and sustainability - assessed by a questionnaire
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

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 10115 (DAIDS-ES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A data sharing statement will be finalized when known which percentage of participants consent for sharing data outside of our own organization.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe