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OPUS School Meal Study

2017. március 3. frissítette: Arne Astrup

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

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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

834

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Dánia
      • Copenhagen, Dánia, 1958
        • Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

8 év (Gyermek)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Alapvető tudomány
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Crossover kiosztás
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Egyéb: NewNordicDiet first
Intervention with NND for 3 mo then no intervention for 3 mo
Egyéb: School meals based on the principles of the New Nordic Diet
The study participants are provided with three daily school meals for 3 month
Egyéb: NewNordicDiet last
No intervention for 3 mo and then intervention with NND for 3 mo
Egyéb: School meals based on the principles of the New Nordic Diet
The study participants are provided with three daily school meals for 3 month

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Metabolic syndrome score
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Early Cardiovascular Risk Markers
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period

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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period

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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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)
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Baseline and change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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
Időkeret: Change during 3 month intervnetion compared with change during 3 month control period
Change during 3 month intervnetion compared with change during 3 month control period
Iron status
Időkeret: Change during 3 month intervention compared with 3 month control period
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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period

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
Időkeret: Change during 3 month of intervention compared with change during 3 month control period
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

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Genotyping
Időkeret: Baseline
SNPs in genes related to metabolic pathways, messenger molecules, receptors or other genes that may affect efficacy measures in OPUS School Food Project
Baseline

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Arne Astrup

Együttműködők

University of Aarhus
University Hospital, Gentofte, Copenhagen
Technical University of Denmark

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2011. május 1.

Elsődleges befejezés (Tényleges)

2012. június 1.

A tanulmány befejezése (Tényleges)

2012. június 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2011. október 20.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2011. október 20.

Első közzététel (Becslés)

2011. október 24.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2017. március 6.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2017. március 3.

Utolsó ellenőrzés

2017. március 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • D208
  • H-1-2010-124 (Egyéb azonosító: The Regional Committee on Biomedical Research Ethics)

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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