OPUS School Meal Study - Cross Sectional Analyses From Baseline Investigations

This study has been completed.
Sponsor:
Collaborators:
Technical University of Denmark
University of Aarhus
University Hospital, Gentofte, Copenhagen
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01577277
First received: April 11, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.


Condition
Metabolic Syndrome X

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Metabolic syndrome score [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.

  • Concentration Performance [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Body weight, Body Mass Index (BMI) [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]

    Body weight (in kg),BMI, BMI z-score calculated on the basis of the current references from WHO and body weight status (underweight/normal weight/overweight and obese) based on the age and gender specific iso BMI´s defined by Cole et al.

    Cole et al. (2000) BMJ 320 (7244): 1240-1243. Cole et al. (2007) BMJ 335 (7612): 194-197.


  • Physical activity [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Physical activity is measured using waist-worn ActiGraph GT3X and GT3X+. Outcome measures will be counts/min, time spent in sedentary, light, moderate and vigorous activities. The participant are asked to note down non-wear periods in a logbook - mainly to increase compliance - and to note the amount of bicycling and if the child was sick within the measurement period. Questions regarding TV-watching, playing with videogames and physical activity, will help identify activity-pattern.

  • Sleep [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Sleep is measured using ActiGraph GT3X and GT3X+ with the monitor placed on the right hip for all students and on the non-dominant wrist for a sub-sample. Using a sleep diary, total sleep time and sleep quality will be derived from these actigraphy measurements. In addition, the abbreviated version of the Children's Sleep Habits Questionnaire (CSHQ) is used to identify sleep problems.

  • Cardio-respiratory fitness [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Cardio-respiratory fitness is measured using the Andersen test, which is a 10-min intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).

  • Dietary intake [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Dietary intake is measured as micro-and macronutrients as well as food groups (e.g. fish and fruit/vegetables) by means of a 7-day dietary survey, which is a web based recall record method developed especially for children. Families without internet access can use a paper version of a 7-day dietary survey. The meal time perception is measured as well.

  • Appetite-regulating hormones [ Time Frame: Baseline (cross-sectional) ] [ Designated as safety issue: No ]
    Leptin and ghrelin. If resources are available at the end of the study period, ghrelin will be separated in acylated and deacylated ghrelin, and both the effect of the intervention on total, acylated, deacylated and the ratio between acylated:deacylated ghrelin will be assessed. If the resources are too tight at the end of the study, only total ghrelin will be used.

  • Vitamin D status [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Serum concentrations of 25-hydroxyvitamin D [25(OH)D] will be used as marker of vitamin D status, related to food intake and time of season.

  • Bone Health [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Bone Health will be evaluated by DXA scanning (total body and spine Bone Mineral Content (BMC), Bone Mineral Density (BMD), and Bone Area (BA). Osteocalcin and serum Parathyreoideahormon (PTH) are also included as markers of bone health.

  • Iron status [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Whole-blood hemoglobin and serum ferritin will be used as measures of iron status

  • Attention - other measures [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]

    The following five measures from the attention test D2 will be used:

    TN=Total Number of items processed E%=Percentage of errors


  • Wellness [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Student wellness is assessed by means of the Danish WRS Wellness Rating Scale filled out by students. The scale contains five subscales and one combined scale (sum score) adding the five subscales. The subscales cover: Living environment, school, school mates, family, and self concept.

  • Learning [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Student learning is assessed by means of the Danish LRS Learning Rating Scale filled out by students. The scale contains four subscales and one combined scale (sum score) adding the four subscales. The subscales cover: Academic learning, social situation in school, teaching style appropriateness, and school expectations.

  • Mathematics proficiency [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Mathematics proficiency is assessed by means of the Danish MG test for 3rd And 4th grade. They each have one measure: Number of correct results within 45 minutes.

  • Reading proficiency [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Reading proficiency is assessed by means of the Danish Sentence Reading test 2 having two measures: Percentage of correct sentences read within eight minutes. Reading speed - number of sentences reached.

  • Use of ADHD medicine [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Among those children with a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD), the mean daily dose of methylphenidate (based on reported intake of drugs containing this substance) during the last two weeks will be evaluated.

  • Illnesses and use of medicine [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Self-reported data collected by personal computer-assisted questionnaire interview with the parents. Outcomes are the number of days, during the last two weeks, with: asthma symptoms, use of asthma-medicine, hay-fever symptoms, use of hay-fever-medicine, atopic eczema, symptoms such as sore throat or fever, and the use of pain killers or antibiotics. The number of days of absence from school due to illness, the number of days of illness during weekends and holidays, and number of visits to the doctor will also be evaluated.

  • Inflammatory markers [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Plasma concentrations of the cytokines Interleucin 6 (IL-6) and Tumor Necrosis factor (TNF-alfa), the adipokine adiponectin and the acute-phase protein C-reative Proetin (CRP)(measured as high-sensitive) in plasma will be used as markers of subclinical inflammation and related to the other early metabolic syndrome and cardiovascular risk markers.

  • Socioeconomic measures [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Self-reported data collected by personal computer-assisted questionnaire interview with the parents. Data are computed on household level. For education and occupation household level = level for the parent or cohabiting partner with the highest value. Education is computed as years of education and as education type. The occupation categorisation is based on the system SOCIO used by Statistics Denmark.

  • Early Cardiovascular Risk Markers [ Time Frame: Baseline (Cross-sectional) ] [ Designated as safety issue: No ]
    Systolic and diastolic blood pressure, serum blood cholesterol (total, LDL, VLDL and HDL) and triglyceride, plasma glucose, serum insulin and the HOMA index.

  • Pubertal status [ Time Frame: cross-sectional (baseline) ] [ Designated as safety issue: No ]
    Pubertal status is assessed by menstruation status (menstruation started or not) and breast development in girls (Tanner stage 1-5) and by development of pubic hair in boys (Tanner stage 1-5).


Biospecimen Retention:   Samples With DNA

serum and white cells


Enrollment: 834
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577277

Locations
Denmark
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen Copenhagen, Denmark
Copenhagen, Denmark, 1958
Sponsors and Collaborators
AAstrup
Technical University of Denmark
University of Aarhus
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Kim F Michaelsen, Professor MD Department of Human Nutrition, Faculty of Science, University of Copenhagen Copenhagen, Denmark
  More Information

Additional Information:
No publications provided

Responsible Party: AAstrup, Professor, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01577277     History of Changes
Other Study ID Numbers: D208 baseline, H-1-2010-124
Study First Received: April 11, 2012
Last Updated: June 14, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Metabolic Syndrome X
Fatty Acids, Omega-3
Learning
Attention
Nutritional Status
Nutrition Assessments
Body Weight
Physical Activity
Sleep
Child Nutrition Sciences

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014