Clinical trial NCT01577277: OPUS School Meal Study - Cross Sectional Analyses From Baseline Investigations
Official title: OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study - - Cross Sectional Analyses From Baseline Investigations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome X
Keywords: Metabolic Syndrome X
Fatty Acids, Omega-3
Learning
Attention
Nutritional Status
Nutrition Assessments
Body Weight
Physical Activity
Sleep
Child Nutrition Sciences
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: University of Aarhus
name: University Hospital, Gentofte, Copenhagen
First posted: 2012-04-13
Enrollment: 834
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: School children participating in OPUS School Meal Study (registered as an intervention study with protocol number: NCT01457794)

Brief summary: The present study is based on cross-sectional data from the baseline investigations carried out in OPUS School Meal Study - a randomized crossover study carried out in 9 primary schools in Denmark 2011-2012. Approximately 800 Danish school children from 3rd and 4th grades (8-12 year olds) took part in these baseline investigations of socioeconomic status, pubertal status, growth status, learning abilities, well-being, sleep, physical activity and risk markers of Cardiovascular Disease (CVD), type II diabetes and osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Pupils in 3rd and 4th grades
* Primary Schools in the Zealand Region and Capital Region of Denmark Schools with an available school kitchen, that can be approved by the food authorities
* Schools where at least 60 % of the pupils in three or more classes signs up to participate in the Study

Exclusion Criteria:

* The children should not participate in a scientific study or have participated in a scientific study within the last 4 weeks. This, however depends on the character of the other study.
* The children must not suffer from serious food allergies or food intolerance.
* The children must not suffer from diseases or conditions that makes them ill-suited for participation in the study, eg. malabsorptive conditions or serious mental disorders
* The schools must not offer an well-established common meal plan, that provides most of the pupils with healthy food on a daily basis

Primary outcomes:
measure: Metabolic syndrome score
timeFrame: Baseline (Cross-sectional)
measure: Body composition
timeFrame: Baseline (Cross-sectional)
measure: Concentration Performance
timeFrame: Baseline (Cross-sectional)
measure: Fatty acid composition in whole-blood
timeFrame: Baseline (cross-sectional)
Secondary outcomes:
measure: Body weight, Body Mass Index (BMI)
timeFrame: Baseline (Cross-sectional)
measure: Physical activity
timeFrame: Baseline (Cross-sectional)
measure: Sleep
timeFrame: Baseline (Cross-sectional)
measure: Cardio-respiratory fitness
timeFrame: Baseline (Cross-sectional)
measure: Dietary intake
timeFrame: Baseline (Cross-sectional)
measure: Appetite-regulating hormones
timeFrame: Baseline (cross-sectional)
measure: Vitamin D status
timeFrame: Baseline (Cross-sectional)
measure: Bone Health
timeFrame: Baseline (Cross-sectional)
measure: Iron status
timeFrame: Baseline (Cross-sectional)
measure: Attention - other measures
timeFrame: Baseline (Cross-sectional)
measure: Wellness
timeFrame: Baseline (Cross-sectional)
measure: Learning
timeFrame: Baseline (Cross-sectional)
measure: Mathematics proficiency
timeFrame: Baseline (Cross-sectional)
measure: Reading proficiency
timeFrame: Baseline (Cross-sectional)
measure: Use of ADHD medicine
timeFrame: Baseline (Cross-sectional)
measure: Illnesses and use of medicine
timeFrame: Baseline (Cross-sectional)
measure: Inflammatory markers
timeFrame: Baseline (Cross-sectional)
measure: Socioeconomic measures
timeFrame: Baseline (Cross-sectional)
measure: Early Cardiovascular Risk Markers
timeFrame: Baseline (Cross-sectional)
measure: Pubertal status
timeFrame: cross-sectional (baseline)
Other outcomes:
measure: Genotyping
timeFrame: Baseline (Cross-sectional)
Locations:
city: Copenhagen
country: Denmark
facility: Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen Copenhagen, Denmark
Study officials:
affiliation: Department of Human Nutrition, Faculty of Science, University of Copenhagen Copenhagen, Denmark
name: Kim F Michaelsen, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Damsgaard CT, Biltoft-Jensen A, Tetens I, Michaelsen KF, Lind MV, Astrup A, Landberg R. Whole-Grain Intake, Reflected by Dietary Records and Biomarkers, Is Inversely Associated with Circulating Insulin and Other Cardiometabolic Markers in 8- to 11-Year-Old Children. J Nutr. 2017 May;147(5):816-824. doi: 10.3945/jn.116.244624. Epub 2017 Mar 29.