Childhood ObesityNCT07389421
School Meals in Denmark
A study testing School meal classes in people with Childhood Obesity and Childhood Obesity Pevention, run by University of Copenhagen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Childhood Obesity Pevention, Well-being/Quality of Life
- What is being tested?
- School meal classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,200 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children attending 3rd, 4th or 7th grade in the recruited schools
Who cannot join
- No exclusion criteria will be applied
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Childhood Obesity, Childhood Obesity Pevention, Well-being/Quality of Life, Diet Habits, Cognitive Abilities, Healthy
- Being tested
- School meal classes
- Keywords
- physical health, well-being, learning, diet
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School meal classesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control classes | Experimental | The classes will continue with their regular meals, e.g. lunch packages Receives: Behavioral: School meal classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being/health related quality of life
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.
Measured: Baseline, 16-22 months
Secondary outcomes (29)
Psychological functioning
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.
Measured: Baseline, 16-22 months
Internalizing problems
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.
Measured: Baseline, 16-22 months
Externalizing problems
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.
Measured: Baseline, 16-22 months
Prosocial Behavior
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.
Measured: Baseline, 16-22 months
Psychological functioning (2)
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.
Measured: Baseline, 16-22 months
Externalizing problems (2)
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.
Measured: Baseline, 16-22 months
Internalizing problems (2)
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.
Measured: Baseline, 16-22 months
Prosocial Behavior (2)
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.
Measured: Baseline, 16-22 months
WHO-5 Well-Being Index
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.
Measured: Baseline, 16-22 months
School environment
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.
Measured: Baseline, 16-22 months
Peers and social support
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.
Measured: Baseline, 16-22 months
Psychological well-being
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.
Measured: Baseline, 16-22 months
Physical well-being
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.
Measured: Baseline, 16-22 months
Resting blood pressure in mmHg
Between group difference in change in systolic and diastolic blood pressure.
Measured: Baseline, 16-22 months
Resting heart rate beats/min
Between group difference in change in heart rate.
Measured: Baseline, 16-22 months
Fat mass in kg
Between group difference in change in fat mass measured by a bioimpedance analysis (InBody 270).
Measured: Baseline, 16-22 months
Fat free mass in kg
Between group difference in change in fat free mass measured by a bioimpedance analysis (InBody 270).
Measured: Baseline, 16-22 months
Fat mass index in kg/m2
Between group difference in change in fat mass index measured by a bioimpedance analysis (InBody 270).
Measured: Baseline, 16-22 months
Fat free mass index in kg/m2
Between group difference in change in fat free mass index measured by a bioimpedance analysis (InBody 270).
Measured: Baseline, 16-22 months
Fat-Free-Mass-to-Fat-Mass ratio
Between group difference in change in FFM-to-FM ratio measured by a bioimpedance analysis (InBody 270).
Measured: Baseline, 16-22 months
% Fat Mass
Between group difference in change in % FM in kg measured by a bioimpedance analysis (InBody 270).
Measured: Baseline, 16-22 months
Weight status in %
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.
Measured: Baseline, 16-22 months
BMI z-score
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.
Measured: Baseline, 16-22 months
Sustained attention
Performance in neuropsychological assessment of sustained attention ability assessed as errors during a sustained test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Measured: Baseline, 16-22 months
Spatial working memory
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).
Measured: Baseline, 16-22 months
Inhibitory control
Performance in neuropsychological assessment of inhibitory control assessed as errors during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Measured: Baseline, 16-22 months
Cognitive flexibility
Performance in neuropsychological assessment of cognitive flexibility assessed as errors during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Measured: Baseline, 16-22 months
Fine motor control
Performance in neuropsychological assessment of fine motor control assessed as endpoint accuracy during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Measured: Baseline, 16-22 months
Processing speed
Performance in neuropsychological assessment of processing speed as choice reaction time (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Measured: Baseline, 16-22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start11 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pragmatic, matched-pair, cluster-randomized study conducted as a natural experiment. Allocation to the school meal program is determined at the school and grade level by a national policy initiative and not by the investigators. Schools are matched in pairs based on socioeconomic and geographic characteristics. Within each matched pair, intervention effects are estimated by comparing classes at the same grade level across schools, where one school implements the school meal program and the matched school does not. Control classes are recruited pragmatically from the same schools at a different grade level than the intervention classes.
- Masking
- None (open label)
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, The Novo Nordic Foundation
- Responsible party
- Principal investigator, Nikolai Nordsborg, University of Copenhagen
- Investigators
- Nikolai B Nordsborg, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389421
- Sponsor's protocol ID
- H-25070631
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If yes: De-identified individual participant data (only collected data, never registry data) will be made available upon reasonable request, subject to approval by the data controllers and in accordance with Danish data protection legislation.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Meals in Denmark: Evaluation of a National School Meal Pilot Program on Children's Health, Learning and Well-being - a Natural Experiment
- ClinicalTrials.gov ID
- NCT07389421
- Acronym / sponsor ID
- H-25070631
- Conditions
- Childhood Obesity, Childhood Obesity Pevention, Well-being/Quality of Life, Diet Habits, Cognitive Abilities, Healthy
- Keywords
- physical health, well-being, learning, diet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Southern Denmark, The Novo Nordic Foundation
- Study start
- 11 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pragmatic, matched-pair, cluster-randomized study conducted as a natural experiment. Allocation to the school meal program is determined at the school and grade level by a national policy initiative and not by the investigators. Schools are matched in pairs based on socioeconomic and geographic characteristics. Within each matched pair, intervention effects are estimated by comparing classes at the same grade level across schools, where one school implements the school meal program and the matched school does not. Control classes are recruited pragmatically from the same schools at a different grade level than the intervention classes.
| Arm | Type | Receives |
|---|---|---|
| Control classes | Experimental | Behavioral: School meal classesThe classes will continue with their regular meals, e.g. lunch packages |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children attending 3rd, 4th or 7th grade in the recruited schools
Key exclusion criteria (1 listed)
- No exclusion criteria will be applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School meal classesNatural 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. | Behavioural | Control classes |
Primary outcome
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.
29 secondary outcomes
Psychological functioning
Time frame: Baseline, 16-22 months
Internalizing problems
Time frame: Baseline, 16-22 months
Externalizing problems
Time frame: Baseline, 16-22 months
Prosocial Behavior
Time frame: Baseline, 16-22 months
Psychological functioning (2)
Time frame: Baseline, 16-22 months
Externalizing problems (2)
Time frame: Baseline, 16-22 months
Internalizing problems (2)
Time frame: Baseline, 16-22 months
Prosocial Behavior (2)
Time frame: Baseline, 16-22 months
WHO-5 Well-Being Index
Time frame: Baseline, 16-22 months
School environment
Time frame: Baseline, 16-22 months
Peers and social support
Time frame: Baseline, 16-22 months
Psychological well-being
Time frame: Baseline, 16-22 months
Physical well-being
Time frame: Baseline, 16-22 months
Resting blood pressure in mmHg
Time frame: Baseline, 16-22 months
Resting heart rate beats/min
Time frame: Baseline, 16-22 months
Fat mass in kg
Time frame: Baseline, 16-22 months
Fat free mass in kg
Time frame: Baseline, 16-22 months
Fat mass index in kg/m2
Time frame: Baseline, 16-22 months
Fat free mass index in kg/m2
Time frame: Baseline, 16-22 months
Fat-Free-Mass-to-Fat-Mass ratio
Time frame: Baseline, 16-22 months
% Fat Mass
Time frame: Baseline, 16-22 months
Weight status in %
Time frame: Baseline, 16-22 months
BMI z-score
Time frame: Baseline, 16-22 months
Sustained attention
Time frame: Baseline, 16-22 months
Spatial working memory
Time frame: Baseline, 16-22 months
Inhibitory control
Time frame: Baseline, 16-22 months
Cognitive flexibility
Time frame: Baseline, 16-22 months
Fine motor control
Time frame: Baseline, 16-22 months
Processing speed
Time frame: Baseline, 16-22 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided. If yes: De-identified individual participant data (only collected data, never registry data) will be made available upon reasonable request, subject to approval by the data controllers and in accordance with Danish data protection legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikolai B Nordsborg, PhD principal investigator
University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A study testing School meal classes in people with Childhood Obesity and Childhood Obesity Pevention, run by University of Copenhagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikolai N Nordsborg, PhD (+4528751612, nbn@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being/health related quality of life (time frame: Baseline, 16-22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.