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临床试验/NCT01577277
NCT01577277已完成不适用

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

Arne Astrup1 个研究点 分布在 1 个国家目标入组 834 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
834
试验地点
1
主要终点
Concentration Performance

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Concentration Performance

时间窗: Baseline (Cross-sectional)

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).

Fatty acid composition in whole-blood

时间窗: Baseline (cross-sectional)

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.

Metabolic syndrome score

时间窗: Baseline (Cross-sectional)

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.

Body composition

时间窗: Baseline (Cross-sectional)

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.

次要结局

  • Cardio-respiratory fitness(Baseline (Cross-sectional))
  • Iron status(Baseline (Cross-sectional))
  • Attention - other measures(Baseline (Cross-sectional))
  • Physical activity(Baseline (Cross-sectional))
  • Wellness(Baseline (Cross-sectional))
  • Body weight, Body Mass Index (BMI)(Baseline (Cross-sectional))
  • Sleep(Baseline (Cross-sectional))
  • Dietary intake(Baseline (Cross-sectional))
  • Bone Health(Baseline (Cross-sectional))
  • Mathematics proficiency(Baseline (Cross-sectional))
  • Appetite-regulating hormones(Baseline (cross-sectional))
  • Vitamin D status(Baseline (Cross-sectional))
  • Reading proficiency(Baseline (Cross-sectional))
  • Learning(Baseline (Cross-sectional))
  • Socioeconomic measures(Baseline (Cross-sectional))
  • Pubertal status(cross-sectional (baseline))
  • Use of ADHD medicine(Baseline (Cross-sectional))
  • Inflammatory markers(Baseline (Cross-sectional))
  • Illnesses and use of medicine(Baseline (Cross-sectional))
  • Early Cardiovascular Risk Markers(Baseline (Cross-sectional))

研究者

发起方
Arne Astrup
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arne Astrup

Professor, MD

University of Copenhagen

研究点 (1)

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