OPUS School Meal Study

Study Overview
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Brief Summary
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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.

Official Title
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OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Other: School meals based on the principles of the New Nordic Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NewNordicDiet first<br>Intervention with NND for 3 mo then no intervention for 3 mo | Other: School meals based on the principles of the New Nordic Diet<br>* The study participants are provided with three daily school meals for 3 month<br>|
| Other: NewNordicDiet last<br>No intervention for 3 mo and then intervention with NND for 3 mo | Other: School meals based on the principles of the New Nordic Diet<br>* The study participants are provided with three daily school meals for 3 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Change during 3 month of intervention compared with change during 3 month control period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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) | 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. | 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. | 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. | 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. | Change during 3 month of intervention compared with change during 3 month control period | 
| General fatty acid composition in whole-blood |  | 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 | 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 | 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 | Change during 3 month of intervention compared with change during 3 month control period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome X, Fatty Acids, Omega-3, Learning, Attention, Nutritional Status, Nutrition Assessments, Body Weight, Physical Activity, Sleep, Child Nutrition Sciences