Healthy School Lunches at Primary Schools in Rotterdam

Healthy Clinical Trial

Official title:

Healthy School Lunch at Primary Schools in Rotterdam, the Netherlands

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058325
• Other study ID #: 10115
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Erasmus Medical Center
• Contact: Wilma Jansen, Dr. ir.
• Phone: +31107038460
• Email: w.jansen.1[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Healthy 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.

Locations

Country	Name	City	State
Netherlands	Department of Public Health, Erasmus MC University Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic variables - assessed by a questionnaire	age, gender, country of birth	Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Other	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.	Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Other	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.	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
Primary	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	Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Secondary	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.	Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Secondary	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.	Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Secondary	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	Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Secondary	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.	Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Secondary	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.	Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Secondary	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	During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline
Secondary	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.	During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline