Clinical trial NCT02377973: Diet and Well-being of Young Danish Children Born by Obese Mothers
Official title: The SKOT II Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children Born by Obese Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth
Overweight
Metabolic Syndrome
Obesity
Keywords: growth,
infancy,
children,
diet,
breastfeeding
complementary feeding
early life programming
tracking
physical activity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: Hvidovre University Hospital
First posted: 2015-03-04
Enrollment: 184
Sex: ALL
Minimum age (years): 9
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young Danish infants born by obese morthers, who during pregnancy were part of a intervention study at Hvidovre Hospital. In the intervention at Hvidovre Hospital study the mothers were asked to join SKOT II,

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Born preterm (before week 37) Non-Danish speaking parents. Chronic disease that is expected to influence growth or food intake.

Primary outcomes:
measure: Change in anthropometric measurements in periods of early childhood
timeFrame: 9, 18 and 36 months of age
measure: Body composition in early childhood
timeFrame: 36 months of age
measure: Markers of Metabolic syndrome in early life
timeFrame: 9 and 36 months of age
measure: Diet in periods of early life
timeFrame: 9, 18 and 36 months of age
Secondary outcomes:
measure: Breastfeeding duration in infancy and early childhood
timeFrame: 9, 18 and 36 months of age
measure: Insulin like growth factor at 9 and 36 months of age
timeFrame: 9 and 36 months of age
measure: Physical activity, sedentary behavior and sleep in early childhood
timeFrame: 9, 18 and 36 months of age
measure: Vitamin D status in infancy
timeFrame: 9 and 36 months of age
measure: Allergy and chronic diseases
timeFrame: 9 and 36 months of age
measure: Appetite hormones in infancy
timeFrame: 9 and 36 months of age
measure: Change in gut microbiota
timeFrame: : 9, 18 and 36 months of age
measure: Achievement of milestones
timeFrame: 9 and 36 months of age
measure: Metabolomics in the urine
timeFrame: 9, 18 and 36 months of age
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition, Faculty of Sciences, University of Copenhagen
Study officials:
affiliation: Faculty of Science, University of Copenhagen
name: Kim F Michaelsen, MD Professor
role: PRINCIPAL_INVESTIGATOR
References: