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临床试验/NCT02170428
NCT02170428已完成不适用

The SKOT I Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
263
试验地点
1
主要终点
Change in anthropometric measurements in periods of early childhood.

研究概览

简要总结

The overall objective with the study was to contribute to the scientific basis for dietary and life strategies, policies and dietary guidelines to infants and young children in Denmark and with special focus on prevention of obesity and diet related chronic diseases such as type 2 diabetes, ischemic heart disease and osteoporosis.

详细描述

The SKOT I study is a prospective cohort study monitoring healthy young children from 9 to 36 months of age. In 2007, 2211 families from Copenhagen were randomly selected through the National Civil Registry and invited to participate in the study by letter. The participants were invited to three examinations at 9 months ±2 weeks, 18 months ±4 weeks and 36 months ±3 months. A total of 330 children are included in the study, where 312 have completed the 9 months examination, 291 completed the 18 months examination and 263 completed the 3-year examination. All examinations took place at Department of Nutrition, Exercise and Sports, Frederiksberg Denmark. The examinations involved collecting a broad spectrum of data. Following data were collected: anthropometry (weight, height, age- and sex-specific Z-scores for body composition, triceps and subscapularis skinfolds), background interview (concerning e.g. infant feeding, household income, the parent's educational level, allergy and chronic diseases), blood pressure (systolic, diastolic and mean arterial pressure), faeces- and urine sample, blood samples (9 and 36 months), Bio impedance analysis (36 months), 7 day diet registration, general questionaire (concerning e.g. sleep, daycare, attendance and use of screen devices), psychomotor questionnaire (motoric development), 7 day physical activity monitoring and dual energy x-ray absorptiometry scan (36 months).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
9 Months 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • healthy singletons born at term (week 37-43) between August 2006 and September 2007 with no disease that could influence food intake or growth

排除标准

  • born preterm (before week 37)
  • non-Danish speaking parents.

结局指标

主要结局

Change in anthropometric measurements in periods of early childhood.

时间窗: 9, 18 and 36 months of age

Composite outcome consisting of body weight, height, body mass index (BMI) and BMI z-scores, waist-, upper arm- and head circumference, skinfold thickness measured at subscapularis and triceps.

Body composition in early childhood

时间窗: 36 months of age

Body composition is measures by Dual-energy X-ray Absorptiometry and bio impedance. Fat mass, fat mass index (kg/m2), fat free mass index (kg/m2) are calculated.

Diet in periods of early life

时间窗: 9, 18 and 36 months of age

The diet is recorded using self-reported 7-day record questionnaire.

Metabolic syndrome score in early life

时间窗: 9 and 36 months of age

Composite outcome consisting of triglycerides, high lipoprotein (HDL) and glucose measured in plasma/serum, waist circumference and blood pressure.

次要结局

  • Insulin like growth factor at 9 and 36 months of age(9 and 36 months of age)
  • Physical activity, sedentary behavior and sleep in early childhood(9, 18 and 36 months of age)
  • Bone mass in 3-year-old children(36 months of age)
  • Vitamin D status in infancy(9 months of age)
  • Allergy and chronic diseases(9 and 36 months of age)
  • Appetite hormones in infancy(9 months of age)
  • Change in gut microbiota(9, 18 and 36 months of age)
  • Achievement of milestones(9 and 36 months of age)
  • Metabolomics in the urine(9, 18 and 36 months of age)
  • Breastfeeding duration in infancy and early childhood(9, 18 and 36 months of age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arne Astrup

Professor, MD

University of Copenhagen

研究点 (1)

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Diet and Well-being of Young Danish Children | 临床试验