The SKOT II Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children Born by Obese Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Body composition in early childhood
研究概览
简要总结
The overall aim is to provide a detailed description of growth, development and risk factors for later disease, especially obesity and metabolic disease in infants born by obese mothers and to compare them with a group of infants born by mothers without any restriction in prepregnancy BMI (SKOT I).
详细描述
The SKOT II is a prospective cohort study that includes children of obese mothers with a body mass index over 30 kg/m2. These mothers were invited to SKOT II while participating in a randomised study at Hvidovre Hospital, Copenhagen. The families were invited to three examinations, when the children were 9, 18 and 36 months of age. A total of 184 children were included in 2010. The examinations and the collecting of data are designed in the same way as SKOT I, a study of healthy children born by non-obese mother. The examinations takes place at Department of Nutrition, Exercise and Sports, Frederiksberg, Denmark. Following data were collected during the examinations: Anthropometry (weight, height, age- and sex specific Z scores for body composition, triceps- and subscapularis skinfolds), background interview (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 samples, blood samples (at 9 and 36 months of age), bio impedance (at 36 months of age), 4 day diet registration, general questionnaire (e.g. sleep, daycare, attendance and use of screen devices), psychomotor questionnaire (motoric development) and 7 day physical activity monitoring (at 36 months of age).
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
- 是
入选标准
- •Healthy singletons born at term (week 37-43) with no disease that could influence food intake or growth. Born by obese mother (BMI ≥ 30 kg/m2) Mothers participated in a intervention study at Hvidovre Hospital
排除标准
- •Born preterm (before week 37) Non-Danish speaking parents. Chronic disease that is expected to influence growth or food intake.
结局指标
主要结局
Body composition in early childhood
时间窗: 36 months of age
Body composition is measures by bio impedance. Fat mass, fat mass index (kg/m2), fat free mass index (kg/m2) are calculated. Compare the measurements with those observed in SKOT-I (NCT02170428)
Markers of Metabolic syndrome in early life
时间窗: 9 and 36 months of age
Markers consisting of triglycerides, high lipoprotein (HDL) and glucose measured in plasma/serum, waist circumference and blood pressure. Compare the measurements with those observed in SKOT-I (NCT02170428)
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. Compare the changes with those observed in SKOT-I (NCT02170428)
Diet in periods of early life
时间窗: 9, 18 and 36 months of age
The diet is recorded using self-reported record questionnaire (7 days at 9 and 18 month, 4 days at 36 month). Compare diet with the SKOT-I cohort (NCT02170428)
次要结局
- Change in gut microbiota(: 9, 18 and 36 months of age)
- Vitamin D status in infancy(9 and 36 months of age)
- Breastfeeding duration in infancy and early childhood(9, 18 and 36 months of age)
- Physical activity, sedentary behavior and sleep in early childhood(9, 18 and 36 months of age)
- Metabolomics in the urine(9, 18 and 36 months of age)
- Insulin like growth factor at 9 and 36 months of age(9 and 36 months of age)
- Allergy and chronic diseases(9 and 36 months of age)
- Appetite hormones in infancy(9 and 36 months of age)
- Achievement of milestones(9 and 36 months of age)
研究者
Arne Astrup
Professor MD
University of Copenhagen