- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06058325
Healthy School Lunches at Primary Schools in Rotterdam
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wilma Jansen, Dr. ir.
- Phone Number: +31107038460
- Email: w.jansen.1@erasmusmc.nl
Study Contact Backup
- Name: Annemieke Wargers, Msc
- Email: a.wargers@erasmusmc.nl
Study Locations
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Rotterdam, Netherlands
- Recruiting
- Department of Public Health, Erasmus MC University Medical Center
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Contact:
- Wilma Jansen
- Email: w.jansen.1@erasmusmc.nl
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Contact:
- Annemieke Wargers
- Email: a.wargers@erasmusmc.nl
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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No Intervention: Control group
Students will bring their own lunch box in the control period.
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Experimental: Intervention group
Students will get a healthy lunch at school in the intervention period.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Observation of type and amount of bread, topping, drinks, fruits, vegetables, and other food products
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Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
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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
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(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
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Perceived health of children - assessed by a questionnaire
Time Frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
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Questions adapted from the GGD (Dutch municipal health service) health monitor: general health, in past week, in past 3 months.
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Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
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Concentration in class - assessed by a questionnaire
Time Frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
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Self-reported question on the ability to concentrate in class.
For children reported on individual level.
For teachers reported on class level.
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Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
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Atmosphere in class - assessed by a questionnaire
Time Frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
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Self-reported questions on the atmosphere in class.
For children reported on individual level.
For teachers reported on class level.
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Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
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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
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Questions adapted from the GGD (Dutch municipal health service) health monitor: difficulties making ends meet & inability to do things due to lack of money
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During intervention arm: depending on the group either approximately 18 weeks after baseline or approximately 36 weeks after baseline
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Taste preferences of children - assessed by a questionnaire
Time Frame: Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
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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
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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
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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
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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
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age, gender, country of birth
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Three times during academic year 2023-2024: baseline/approximately 18 weeks/approximately 36 weeks
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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
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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
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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
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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
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10115 (DAIDS-ES)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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