OPUS School Meal Study - Cross Sectional Analyses From Baseline Investigations

Metabolic Syndrome X Clinical Trial

Official title:

OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study - - Cross Sectional Analyses From Baseline Investigations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577277
• Other study ID #: D208 baseline
• Secondary ID: H-1-2010-124
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: March 3, 2017
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present study is based on cross-sectional data from the baseline investigations carried out in OPUS School Meal Study - a randomized crossover study carried out in 9 primary schools in Denmark 2011-2012. Approximately 800 Danish school children from 3rd and 4th grades (8-12 year olds) took part in these baseline investigations of socioeconomic status, pubertal status, growth status, learning abilities, well-being, sleep, physical activity and risk markers of Cardiovascular Disease (CVD), type II diabetes and osteoporosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 834
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome X

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen Copenhagen, Denmark	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Arne Astrup	Technical University of Denmark, University Hospital, Gentofte, Copenhagen, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genotyping	SNPs in genes related to metabolic pathways, messenger molecules, receptors or other genes that may affect efficacy measures in OPUS School Food Project	Baseline (Cross-sectional)
Primary	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.	Baseline (Cross-sectional)
Primary	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.	Baseline (Cross-sectional)
Primary	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).	Baseline (Cross-sectional)
Primary	Fatty acid composition in whole-blood	Content of saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, total n-3 and n-6 polyunsaturated fatty acids, eicosapentaenoic acid, docosahexaenoic acid, and the n-6:n-3 ratio in whole-blood measured as weight% relative to the weight of total fatty acids.	Baseline (cross-sectional)
Secondary	Body weight, Body Mass Index (BMI)	Body weight (in kg),BMI, BMI z-score calculated on the basis of the current references from WHO and body weight status (underweight/normal weight/overweight and obese) based on the age and gender specific iso BMI´s defined by Cole et al.; Cole et al. (2000) BMJ 320 (7244): 1240-1243. Cole et al. (2007) BMJ 335 (7612): 194-197.	Baseline (Cross-sectional)
Secondary	Physical activity	Physical activity is measured using waist-worn ActiGraph GT3X and GT3X+. Outcome measures will be counts/min, time spent in sedentary, light, moderate and vigorous activities. The participant are asked to note down non-wear periods in a logbook - mainly to increase compliance - and to note the amount of bicycling and if the child was sick within the measurement period. Questions regarding TV-watching, playing with videogames and physical activity, will help identify activity-pattern.	Baseline (Cross-sectional)
Secondary	Sleep	Sleep is measured using ActiGraph GT3X and GT3X+ 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 quality will be derived from these actigraphy measurements. In addition, the abbreviated version of the Children's Sleep Habits Questionnaire (CSHQ) is used to identify sleep problems.	Baseline (Cross-sectional)
Secondary	Cardio-respiratory fitness	Cardio-respiratory fitness is measured using the Andersen test, which is a 10-min intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).	Baseline (Cross-sectional)
Secondary	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.	Baseline (Cross-sectional)
Secondary	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.	Baseline (cross-sectional)
Secondary	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 (Cross-sectional)
Secondary	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.	Baseline (Cross-sectional)
Secondary	Iron status	Whole-blood hemoglobin and serum ferritin will be used as measures of iron status	Baseline (Cross-sectional)
Secondary	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	Baseline (Cross-sectional)
Secondary	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.	Baseline (Cross-sectional)
Secondary	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.	Baseline (Cross-sectional)
Secondary	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.	Baseline (Cross-sectional)
Secondary	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.	Baseline (Cross-sectional)
Secondary	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.	Baseline (Cross-sectional)
Secondary	Illnesses and use of medicine	Self-reported data collected by personal computer-assisted questionnaire interview with the parents. 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.	Baseline (Cross-sectional)
Secondary	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-reative Proetin (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.	Baseline (Cross-sectional)
Secondary	Socioeconomic measures	Self-reported data collected by personal computer-assisted questionnaire interview with the parents. Data are computed on household level. For education and occupation household level = level for the parent or cohabiting partner with the highest value. Education is computed as years of education and as education type. The occupation categorisation is based on the system SOCIO used by Statistics Denmark.	Baseline (Cross-sectional)
Secondary	Early Cardiovascular Risk Markers	Systolic and diastolic blood pressure, serum blood cholesterol (total, LDL, VLDL and HDL) and triglyceride, plasma glucose, serum insulin and the HOMA index.	Baseline (Cross-sectional)
Secondary	Pubertal status	Pubertal status is assessed by menstruation status (menstruation started or not) and breast development in girls (Tanner stage 1-5) and by development of pubic hair in boys (Tanner stage 1-5).	cross-sectional (baseline)

External Links

•   Research group homepage
•   Study homepage