OPUS School Meal Study

This study has been completed.
Sponsor:
Collaborators:
Technical University of Denmark
University of Aarhus
University Hospital, Gentofte, Copenhagen
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01457794
First received: October 20, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome X
Other: School meals based on the principles of the New Nordic Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Metabolic syndrome score [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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 at baseline.

  • Concentration Performance [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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).


Secondary Outcome Measures:
  • Early Cardiovascular Risk Markers [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ Designated as safety issue: No ]
    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.

  • Other metabolic syndrome scores [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ Designated as safety issue: No ]
    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.

  • Inflammatory markers [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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-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.

  • Illnesses and use of medicine [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ Designated as safety issue: No ]
    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.

  • Use of ADHD medicine [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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.

  • General fatty acid composition of whole-blood [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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 and the n-6:n-3 ratio in whole-blood measured as weight% relative to the weight of total fatty acids.

  • Reading proficiency [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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.

  • Mathematics proficiency [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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.

  • Learning [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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.

  • Wellness [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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.

  • Physical activity [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ Designated as safety issue: No ]

    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.


  • Sleep [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ Designated as safety issue: No ]

    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.


  • Fitness [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ Designated as safety issue: No ]
    Fitness is measured using the Andersen test, which is an intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).

  • Dietary intake [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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.

  • Body weight and body mass index (BMI) [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ Designated as safety issue: No ]
    Body weight (in kg, BMI and BMI z-score calculated on the basis of the current references from the World Health Organization (WHO)

  • Body composition [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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.

  • Appetite-regulating hormones [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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 and change during 3 month of intervention compared with change during 3 month control period ] [ 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: Change during 3 month of intervention compared with change during 3 month control period ] [ 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.

  • General fatty acid composition in whole-blood [ Time Frame: Change during 3 month intervnetion compared with change during 3 month control period ] [ Designated as safety issue: No ]
  • Iron status [ Time Frame: Change during 3 month intervention compared with 3 month control period ] [ Designated as safety issue: No ]
    Whole-blood hemoglobin and serum ferritin will be used as measures of iron status

  • Attention - other measures [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ 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


  • Omega-3 index in whole-blood [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ] [ Designated as safety issue: No ]
    The Omega-3 index in whole-blood is defined as the weight percentage of eicosapentaenoicacid + the weight percentage of docosahexaenoic acid in whole-blood


Enrollment: 834
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
NewNordicDiet first
Intervention with NND for 3 mo then no intervention for 3 mo
Other: School meals based on the principles of the New Nordic Diet
The study participants are provided with three daily school meals for 3 month
NewNordicDiet last
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
The study participants are provided with three daily school meals for 3 month

  Eligibility

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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: NCT01457794

Locations
Denmark
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Copenhagen, Denmark, 1958
Sponsors and Collaborators
Arne Astrup
Technical University of Denmark
University of Aarhus
University Hospital, Gentofte, Copenhagen
  More Information

Additional Information:
No publications provided

Responsible Party: Arne Astrup, Professor, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01457794     History of Changes
Other Study ID Numbers: D208, H-1-2010-124
Study First Received: October 20, 2011
Last Updated: August 4, 2014
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
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014