OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study
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
- 2
- 主要终点
- Concentration Performance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
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: 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).
Metabolic syndrome score
时间窗: 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.
次要结局
- Mathematics proficiency(Change during 3 month of intervention compared with change during 3 month control period)
- Early Cardiovascular Risk Markers(Change during 3 month of intervention compared with change during 3 month control period)
- Use of ADHD medicine(Change during 3 month of intervention compared with change during 3 month control period)
- Body weight and body mass index (BMI)(Change during 3 month of intervention compared with change during 3 month control period)
- Iron status(Change during 3 month intervention compared with 3 month control period)
- Inflammatory markers(Change during 3 month of intervention compared with change during 3 month control period)
- General fatty acid composition of whole-blood(Change during 3 month of intervention compared with change during 3 month control period)
- Sleep(Change during 3 month of intervention compared with change during 3 month control period)
- Dietary intake(Change during 3 month of intervention compared with change during 3 month control period)
- Illnesses and use of medicine(Change during 3 month of intervention compared with change during 3 month control period)
- Reading proficiency(Change during 3 month of intervention compared with change during 3 month control period)
- Learning(Change during 3 month of intervention compared with change during 3 month control period)
- Other metabolic syndrome scores(Change during 3 month of intervention compared with change during 3 month control period)
- Wellness(Change during 3 month of intervention compared with change during 3 month control period)
- Physical activity(Change during 3 month of intervention compared with change during 3 month control period)
- Fitness(Change during 3 month of intervention compared with change during 3 month control period)
- Bone Health(Change during 3 month of intervention compared with change during 3 month control period)
- Omega-3 index in whole-blood(Change during 3 month of intervention compared with change during 3 month control period)
- Body composition(Change during 3 month of intervention compared with change during 3 month control period)
- General fatty acid composition in whole-blood(Change during 3 month intervnetion compared with change during 3 month control period)
- Appetite-regulating hormones(Change during 3 month of intervention compared with change during 3 month control period)
- Vitamin D status(Baseline and change during 3 month of intervention compared with change during 3 month control period)
- Attention - other measures(Change during 3 month of intervention compared with change during 3 month control period)
研究者
Arne Astrup
Professor, MD
University of Copenhagen