NCT06058325

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

August 31, 2023

Last Update Submit

October 2, 2023

Conditions

Keywords

Healthy lunchDietChildrenSchoolEffectivityFeasibility

Outcome Measures

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

    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

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

  • Perceived health of children - assessed by a questionnaire

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

  • Taste preferences of children - assessed by a questionnaire

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

  • Concentration in class - assessed by a questionnaire

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

  • Atmosphere in class - assessed by a questionnaire

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

  • +2 more secondary outcomes

Other Outcomes (3)

  • Demographic variables - assessed by a questionnaire

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

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

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

  • Feasibility data on implementation and sustainability - assessed by a questionnaire

    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

Study Arms (2)

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.

Other: Healthy school lunch

Interventions

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.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public Health, Erasmus MC University Medical Center

Rotterdam, Netherlands

RECRUITING

Related Publications (3)

  • 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.

    PMID: 34579117BACKGROUND
  • 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.

    PMID: 32398052BACKGROUND
  • Wargers 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.

Central Study Contacts

Wilma Jansen, Dr. ir.

CONTACT

Annemieke Wargers, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 28, 2023

Study Start

September 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations