Clinical trial NCT06058325: Healthy School Lunches at Primary Schools in Rotterdam
Official title: Healthy School Lunch at Primary Schools in Rotterdam, the Netherlands
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Healthy lunch
Diet
Children
School
Effectivity
Feasibility
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dietary content of children's lunches - assessed by an observation form
timeFrame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
Secondary outcomes:
measure: General dietary behaviour of children - assessed by a questionnaire
timeFrame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
measure: Perceived health of children - assessed by a questionnaire
timeFrame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
measure: Taste preferences of children - assessed by a questionnaire
timeFrame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
measure: Concentration in class - assessed by a questionnaire
timeFrame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
measure: Atmosphere in class - assessed by a questionnaire
timeFrame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
measure: Financial situation of parents - assessed by a questionnaire
timeFrame: During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline
measure: Satisfaction of the healthy school lunch - assessed by a questionnaire
timeFrame: During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline
Other outcomes:
measure: Demographic variables - assessed by a questionnaire
timeFrame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
measure: Type of dietary requirement(s) - assessed by a questionnaire
timeFrame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
measure: Feasibility data on implementation and sustainability - assessed by a questionnaire
timeFrame: 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
Locations:
city: Rotterdam
country: Netherlands
facility: Department of Public Health, Erasmus MC University Medical Center
Study officials:
References:
citation: 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.
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.