- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07389421
School Meals in Denmark
School Meals in Denmark: Evaluation of a National School Meal Pilot Program on Children's Health, Learning and Well-being - a Natural Experiment
This study looks at how a national school meal program affects the health, well-being, and learning of Danish schoolchildren aged 10 to 15 years.
The study is part of the Danish National School Meal Pilot Program (2025-2028), which provides free school meals at selected public schools. Some school classes receive free school meals, while other classes do not and are used for comparison.
Children are followed for about 1.5 years. Information is collected before and after the program using simple health measurements, questionnaires about well-being, and age-appropriate cognitive tests.
The study also uses information from Danish national registers to better understand the children's background and to study longer-term outcomes related to health, education, and social conditions. In addition, the study examines whether school meal programs are cost-effective by comparing their costs with potential benefits for children and society.
The goal of the study is to find out whether free school meals can improve children's health, well-being, and learning, and help reduce social differences.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
School Meals in Denmark is a prospective, open-label, matched-pair cluster-randomized controlled study conducted as a natural experiment alongside the Danish National School Meal Pilot Program. As allocation to the national program is determined by the Danish Ministry of Children and Education and not by the investigators, the study evaluates the effects of school meals under real-world conditions without introducing an additional experimental intervention.
Approximately 3,200 children in grades 3, 4, and 7 from 32 public schools are included. Participating schools are matched in pairs based on socioeconomic and geographic characteristics using national statistical data. Recruitment includes schools implementing the program either at the middle grades or at the lower secondary level. At each school, intervention classes are identified at the grade level receiving school meals.
Control classes are recruited pragmatically from the same schools but at a different grade level than the intervention classes. Intervention effects are estimated by comparing classes at the same grade level across matched schools, where one school implements the school meal program at that grade and the matched school does not. This approach allows for within-school control recruitment while preserving between-school comparisons at the same grade level.
Data are collected at two time points over a follow-up period of approximately 1.5 years using a pre-post design. Outcomes include anthropometric measures (height, weight, body composition assessed by bioelectrical impedance), cardiovascular indicators (blood pressure and resting heart rate), tablet-based cognitive performance tests, and child-reported questionnaires on well-being and psychosocial functioning. Parents complete brief electronic questionnaires addressing their child's psychosocial functioning and dietary habits.
In addition, observations of school meal settings are conducted to assess food intake and food waste, and menu plans from meal providers are collected to evaluate nutritional quality and compliance with dietary guidelines.
The study is designed to generate robust evidence on the real-world effects of school meal programs on children's health, well-being, and learning outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nikolai N Nordsborg, PhD
- Phone Number: +4528751612
- Email: nbn@nexs.ku.dk
Study Contact Backup
- Name: Paulina S Melby, PhD
- Phone Number: +4527266039
- Email: paulina@nexs.ku.dk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All children attending 3rd, 4th or 7th grade in the recruited schools
Exclusion Criteria:
- No exclusion criteria will be applied
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control classes
The classes will continue with their regular meals, e.g.
lunch packages
|
Natural experiment embedded within the Danish National School Meal Pilot Program (2025-2028), which offers free school meals to selected public schools. Children receive a free school-provided meal (typically lunch) five days per week. Meals vary across schools, as each school selects its own meal provider. All meals must comply with the Nordic Nutrition Recommendations and the Danish Food-Based Dietary Guidelines, with a focus on fish, whole grains, fruits and vegetables, access to drinking water, and the promotion of children's food literacy. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-being/health related quality of life
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the total summary score of health-related quality of life measured with the KIDSCREEN 27 child self-report questionnaire.
Data is collected using an adapted video and speech assisted electronic version with a smiley scale for each answer.
The questionnaire assesses the child's physical well-being (5 items), psychological well-being (7 items), peers and social support (4 items), and school environment (4 items).
Autonomy and parent relation (7 items) are not used.
|
Baseline, 16-22 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological functioning
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the total difficulties score of the Strengths and difficulties questionnaire.
Assessed using child reported version of the Strengths and Difficulties Questionnaire.
An overall total difficulties score is calculated, along with five subscale scores: emotional symptoms, conduct problems, hyperactivity/Inattention, relationship problems, and prosocial behavior.
|
Baseline, 16-22 months
|
|
Internalizing problems
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the internalizing problem score of the Strengths and difficulties questionnaire, calculated as the sum of the emotional symptoms and peer problems scales scores.
Assessed using the child-reported version of the Strengths and Difficulties Questionnaire.
|
Baseline, 16-22 months
|
|
Externalizing problems
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the externalizing behavior score of the Strengths and difficulties questionnaire, calculated as the sum of conduct problems, hyperactivity/Inattention subscales scores.
Assessed using the child-reported version of the Strengths and Difficulties Questionnaire.
|
Baseline, 16-22 months
|
|
Prosocial Behavior
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the prosocial behavior score of the Strengths and difficulties questionnaire.
Assessed using the child-reported version of the Strengths and Difficulties Questionnaire.
|
Baseline, 16-22 months
|
|
Psychological functioning (2)
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the total difficulties score of the Strengths and difficulties questionnaire.
Assessed using parent reported version of the Strengths and Difficulties Questionnaire.
An overall total difficulties score is calculated, along with five subscale scores: emotional symptoms, conduct problems, hyperactivity/Inattention, relationship problems, and prosocial behavior.
|
Baseline, 16-22 months
|
|
Externalizing problems (2)
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the externalizing behavior score of the Strengths and difficulties questionnaire, calculated as the sum of conduct problems, hyperactivity/Inattention subscales scores.
Assessed using the parent-reported version of the Strengths and Difficulties Questionnaire.
|
Baseline, 16-22 months
|
|
Internalizing problems (2)
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the internalizing problem score of the Strengths and difficulties questionnaire, calculated as the sum of the emotional symptoms and peer problems scales scores.
Assessed using the parent-reported version of the Strengths and Difficulties Questionnaire.
|
Baseline, 16-22 months
|
|
Prosocial Behavior (2)
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the prosocial behavior score of the Strengths and difficulties questionnaire.
Assessed using the parent-reported version of the Strengths and Difficulties Questionnaire.
|
Baseline, 16-22 months
|
|
WHO-5 Well-Being Index
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the 5-question self-report tool from the World Health Organization measuring subjective mental well-being over the past two weeks, assessing feelings like cheerfulness, calmness, and interest.
|
Baseline, 16-22 months
|
|
School environment
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the school environment (4 items) score of the KIDSCREEN 27 child self-report questionnaire.
Data is collected using an adapted video and speech assisted electronic version with a smiley scale for each answer.
|
Baseline, 16-22 months
|
|
Peers and social support
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the peers and social support (4 items) score of the KIDSCREEN 27 child self-report questionnaire.
Data is collected using an adapted video and speech assisted electronic version with a smiley scale for each answer.
|
Baseline, 16-22 months
|
|
Psychological well-being
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the psychological well-being (7 items) score of the KIDSCREEN 27 child self-report questionnaire.
Data is collected using an adapted video and speech assisted electronic version with a smiley scale for each answer.
|
Baseline, 16-22 months
|
|
Physical well-being
Time Frame: Baseline, 16-22 months
|
Between group difference in change in the physical well-being (5 items) score of the KIDSCREEN 27 child self-report questionnaire.
Data is collected using an adapted video and speech assisted electronic version with a smiley scale for each answer.
|
Baseline, 16-22 months
|
|
Resting blood pressure in mmHg
Time Frame: Baseline, 16-22 months
|
Between group difference in change in systolic and diastolic blood pressure.
|
Baseline, 16-22 months
|
|
Resting heart rate beats/min
Time Frame: Baseline, 16-22 months
|
Between group difference in change in heart rate.
|
Baseline, 16-22 months
|
|
Fat mass in kg
Time Frame: Baseline, 16-22 months
|
Between group difference in change in fat mass measured by a bioimpedance analysis (InBody 270).
|
Baseline, 16-22 months
|
|
Fat free mass in kg
Time Frame: Baseline, 16-22 months
|
Between group difference in change in fat free mass measured by a bioimpedance analysis (InBody 270).
|
Baseline, 16-22 months
|
|
Fat mass index in kg/m2
Time Frame: Baseline, 16-22 months
|
Between group difference in change in fat mass index measured by a bioimpedance analysis (InBody 270).
|
Baseline, 16-22 months
|
|
Fat free mass index in kg/m2
Time Frame: Baseline, 16-22 months
|
Between group difference in change in fat free mass index measured by a bioimpedance analysis (InBody 270).
|
Baseline, 16-22 months
|
|
Fat-Free-Mass-to-Fat-Mass ratio
Time Frame: Baseline, 16-22 months
|
Between group difference in change in FFM-to-FM ratio measured by a bioimpedance analysis (InBody 270).
|
Baseline, 16-22 months
|
|
% Fat Mass
Time Frame: Baseline, 16-22 months
|
Between group difference in change in % FM in kg measured by a bioimpedance analysis (InBody 270).
|
Baseline, 16-22 months
|
|
Weight status in %
Time Frame: Baseline, 16-22 months
|
Between group difference in change in prevalence of children with underweight, normalweight, overweight and obesity, based on the cutoffs defined by Cole et al. and the International Task Force of Obesity.
Body weight is measured by a bioimpedance analysis (InBody 270) and height by using a portable stadiometer.
|
Baseline, 16-22 months
|
|
BMI z-score
Time Frame: Baseline, 16-22 months
|
Between group difference in change in BMI z-score based on WHO references.
Weight and height is measured using weight from the bioimpedance analysis (InBody 270) and a portable stadiometer, respectively.
|
Baseline, 16-22 months
|
|
Sustained attention
Time Frame: Baseline, 16-22 months
|
Performance in neuropsychological assessment of sustained attention ability assessed as errors during a sustained test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
|
Baseline, 16-22 months
|
|
Spatial working memory
Time Frame: Baseline, 16-22 months
|
Performance in neuropsychological assessment of spatial working memory assessed as errors and strategy during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
|
Baseline, 16-22 months
|
|
Inhibitory control
Time Frame: Baseline, 16-22 months
|
Performance in neuropsychological assessment of inhibitory control assessed as errors during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
|
Baseline, 16-22 months
|
|
Cognitive flexibility
Time Frame: Baseline, 16-22 months
|
Performance in neuropsychological assessment of cognitive flexibility assessed as errors during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
|
Baseline, 16-22 months
|
|
Fine motor control
Time Frame: Baseline, 16-22 months
|
Performance in neuropsychological assessment of fine motor control assessed as endpoint accuracy during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
|
Baseline, 16-22 months
|
|
Processing speed
Time Frame: Baseline, 16-22 months
|
Performance in neuropsychological assessment of processing speed as choice reaction time (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
|
Baseline, 16-22 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nikolai B Nordsborg, PhD, University of Copenhagen
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-25070631
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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