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OPUS School Meal Study

3 marzo 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

834

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 8 anni a 11 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: NewNordicDiet first
Intervention with NND for 3 mo then no intervention for 3 mo
Altro: School meals based on the principles of the New Nordic Diet
The study participants are provided with three daily school meals for 3 month
Altro: NewNordicDiet last
No intervention for 3 mo and then intervention with NND for 3 mo
Altro: School meals based on the principles of the New Nordic Diet
The study participants are provided with three daily school meals for 3 month

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Metabolic syndrome score
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Early Cardiovascular Risk Markers
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Genotyping
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Arne Astrup

Collaboratori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2011

Completamento primario (Effettivo)

1 giugno 2012

Completamento dello studio (Effettivo)

1 giugno 2012

Date di iscrizione allo studio

Primo inviato

20 ottobre 2011

Primo inviato che soddisfa i criteri di controllo qualità

20 ottobre 2011

Primo Inserito (Stima)

24 ottobre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 marzo 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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