The aim of this randomized crossover study, is to investigate the effect of school meals based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep quality, physical activity and risk markers of cardiovascular disease (CVD), type II diabetes and osteoporosis in 8-11 year old Danish school children. The participating 3rd and 4th grades on 9 selected primary schools will be randomized to either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual school lunch for 3 mo and then crossover for additional 3 mo. All participants will be examined three times; at baseline, after 3 mo and after 6 mo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
834
The study participants are provided with three daily school meals for 3 month
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Copenhagen, Denmark
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 at baseline.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
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).
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Early Cardiovascular Risk Markers
Systolic and diastolic blood pressure, serum blood cholesterol (total, Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL) and HDL) and TG, plasma glucose, serum insulin and the HOMA index.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Other metabolic syndrome scores
Other metabolic syndrome scores will be calculated as continuous z-scores based on each of the individual z-scores for Waist Circumference (WC), Mean Arterial Pressure (MAP), serum High Density Lipoprotein (HDL), serum Triglyceride (TG) and insulin, separately, and possibly with weighted contribution of each of the risk markers to the score.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Inflammatory markers
Plasma concentrations of the cytokines Interleucin-6 (IL-6) and Tumor Necrosis Factor (TNF) alfa, the adipokine adiponectin and the acute-phase protein c-reactive protein (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.
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Time frame: Change during 3 month of intervention compared with change during 3 month control period
Illnesses and use of medicine
Self-reported data collected by computer-assisted questionnaire interview with the parents, either personal (month 0) or by telephone (month 3 and 6). 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.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Use of ADHD medicine
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.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
General fatty acid composition of whole-blood
Content of saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, total n-3 and n-6 polyunsaturated fatty acids and the n-6:n-3 ratio in whole-blood measured as weight% relative to the weight of total fatty acids.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Reading proficiency
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.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Mathematics proficiency
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.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Learning
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.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Wellness
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.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Physical activity
Physical activity is measured using actigraphy. Outcome measures will be counts/min, time spent in sedentary, light, moderate and vigorous activities. Questions regarding TV-watching, playing with videogames and physical activity, will help identify activity-pattern.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Sleep
Sleep is measured using actigraphy 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 efficiency will be derived from these actigraphy measurements. In addition, at month 0, the abbreviated version of the Children's Sleep Habits Questionnaire (CSHQ) is used to identify sleep problems.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Fitness
Fitness is measured using the Andersen test, which is an intermittent running test to estimate maximal oxygen uptake (mL\*min-1\*kg-1).
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Dietary intake
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.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Body weight and body mass index (BMI)
Body weight (in kg, BMI and BMI z-score calculated on the basis of the current references from the World Health Organization (WHO)
Time frame: Change during 3 month of intervention compared with change during 3 month control period
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.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Appetite-regulating hormones
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.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Vitamin D status
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.
Time frame: Baseline and change during 3 month of intervention compared with change during 3 month control period
Bone Health
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.
Time frame: Change during 3 month of intervention compared with change during 3 month control period
General fatty acid composition in whole-blood
Time frame: Change during 3 month intervnetion compared with change during 3 month control period
Iron status
Whole-blood hemoglobin and serum ferritin will be used as measures of iron status
Time frame: Change during 3 month intervention compared with 3 month control period
Attention - other measures
The following five measures from the attention test D2 will be used: TN=Total Number of items processed E%=Percentage of errors
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Omega-3 index in whole-blood
The Omega-3 index in whole-blood is defined as the weight percentage of eicosapentaenoicacid + the weight percentage of docosahexaenoic acid in whole-blood
Time frame: Change during 3 month of intervention compared with change during 3 month control period