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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 834
- Locations
- 1
- Primary Endpoint
- Concentration Performance
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Concentration Performance
Time Frame: Baseline (Cross-sectional)
Concentration Performance is assessed by means of a concentration test called the D2-test of Attention. Concentration Performance is derived from the number of correctly crossed out relevant items minus the errors of commission (confused).
Fatty acid composition in whole-blood
Time Frame: Baseline (cross-sectional)
Content of saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, total n-3 and n-6 polyunsaturated fatty acids, eicosapentaenoic acid, docosahexaenoic acid, and the n-6:n-3 ratio in whole-blood measured as weight% relative to the weight of total fatty acids.
Metabolic syndrome score
Time Frame: Baseline (Cross-sectional)
The metabolic syndrome score is a continuous z-score based on individual z-scores for Waist Circumference (WC), Mean Arterial Pressure (MAP), serum High Density Lipoprotein (HDL), serum Triglyceride (TG) and Homeostasis Model Assessment (HOMA) index. It´s an internal score meaning that the basis for the score is the distribution of values in this study population.
Body composition
Time Frame: Baseline (Cross-sectional)
Body composition will be determined by Dual energy X-ray Absorptiometry (DXA) scanning. The parameters included are total body Fat Free Mass Index (FFMI in kg/m2), total body Fat Mass Index (FMI in kg/m2), total body fat percentage and the ratio between android and gynoid fat mass in kg.
Secondary Outcomes
- Body weight, Body Mass Index (BMI)(Baseline (Cross-sectional))
- Cardio-respiratory fitness(Baseline (Cross-sectional))
- Iron status(Baseline (Cross-sectional))
- Attention - other measures(Baseline (Cross-sectional))
- Physical activity(Baseline (Cross-sectional))
- Wellness(Baseline (Cross-sectional))
- Illnesses and use of medicine(Baseline (Cross-sectional))
- Early Cardiovascular Risk Markers(Baseline (Cross-sectional))
- Sleep(Baseline (Cross-sectional))
- Dietary intake(Baseline (Cross-sectional))
- Bone Health(Baseline (Cross-sectional))
- Mathematics proficiency(Baseline (Cross-sectional))
- Appetite-regulating hormones(Baseline (cross-sectional))
- Vitamin D status(Baseline (Cross-sectional))
- Reading proficiency(Baseline (Cross-sectional))
- Learning(Baseline (Cross-sectional))
- Socioeconomic measures(Baseline (Cross-sectional))
- Pubertal status(cross-sectional (baseline))
- Use of ADHD medicine(Baseline (Cross-sectional))
- Inflammatory markers(Baseline (Cross-sectional))
Investigators
Arne Astrup
Professor, MD
University of Copenhagen