Clinical Trial: OPUS School Meal Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Arne Astrup

Current Primary Outcome:

  • Metabolic syndrome score [ Time Frame: 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.
  • Concentration Performance [ Time Frame: 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).


Original Primary Outcome:

  • Metabolic syndrome score [ Time Frame: 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.
  • Omega-3 index in whole-blood [ Time Frame: 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
  • Attention score [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ]
    Attention score assessed by means of an attention test called the D2 test having the following five measures: TN= Total Number of Items Processed. E = Raw score of Errors. E% = Percentage of errors. TN-E = Total Number of Items Minus Error Scores. FR = The Fluctuation Rate (the maximum difference between the TN scores on the individual series).


Current Secondary Outcome:

  • Early Cardiovascular Risk Markers [ Time Frame: 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.
  • Other metabolic syndrome scores [ Time Frame: 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.
  • Inflammatory markers [ Time Frame: 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.
  • Illnesses and use of medicine [ Time Frame: 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.
  • Use of ADHD medicine [ Time Frame: 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.
  • General fatty acid composition of whole-blood [ Time Frame: 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.
  • Reading proficiency [ Time Frame: 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.
  • Mathematics proficiency [ Time Frame: 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.
  • Learning [ Time Frame: 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.
  • Wellness [ Time Frame: 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.
  • Physical activity [ Time Frame: 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.

  • Sleep [ Time Fra

    Original Secondary Outcome:

    • Early Cardiovascular Risk Markers [ Time Frame: Change during 3 month of intervention compared with change during 3 month control period ]
      Systolic and diastolic blood pressure, serum blood cholesterol (total, LDL, VLDL and HDL) and triglyceride, 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 ]
      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 ]
      Plasma concentrations of the cytokines IL-6 and TNF-alfa, the adipokine adiponectin and the acute-phase 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 ]
      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 ]
      Among those children with a diagnosis of ADHD or 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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]

      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 ]