OPUS School Meal Study - Cross Sectional Analyses From Baseline Investigations

NCT01577277 | Completed

• 2 other identifiers: D208 baselineH-1-2010-124
• Study Type: observational
• Target: 834
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Metabolic syndrome score

  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.

  Baseline (Cross-sectional)

• Body composition

  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.

  Baseline (Cross-sectional)

• Concentration Performance

  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).

  Baseline (Cross-sectional)

• Fatty acid composition in whole-blood

  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.

  Baseline (cross-sectional)

Secondary Outcomes (20)

• Body weight, Body Mass Index (BMI)

  Baseline (Cross-sectional)

• Physical activity

  Baseline (Cross-sectional)

• Sleep

  Baseline (Cross-sectional)

• Cardio-respiratory fitness

  Baseline (Cross-sectional)

• Dietary intake

  Baseline (Cross-sectional)

Other Outcomes (1)

• Genotyping

  Baseline (Cross-sectional)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

School children participating in OPUS School Meal Study (registered as an intervention study with protocol number: NCT01457794)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arne Astrup: lead
• Technical University of Denmark: collaborator
• University of Aarhus: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (1)

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen Copenhagen, Denmark

Copenhagen, 1958, Denmark

Location

Related Publications (1)

• 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.

  PMID: 28356426 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum and white cells

MeSH Terms

Conditions

Metabolic Syndrome; Body Weight; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Kim F Michaelsen, Professor MD

  Department of Human Nutrition, Faculty of Science, University of Copenhagen Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 13, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

DK (1)