Diet and Well-being of Young Danish Children Born by Obese Mothers

Overview

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).

Full Title of Study: “The SKOT II Cohort – a Prospective Cohort Study of Diet and Well-being in Young Danish Children Born by Obese Mothers”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2015

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).

Arms, Groups and Cohorts

  • Growth and Development
    • Growth and Development og healthy young children born by Obese mothers

Clinical Trial Outcome Measures

Primary Measures

  • Change in anthropometric measurements in periods of early childhood
    • Time Frame: 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)
  • Body composition in early childhood
    • Time Frame: 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
    • Time Frame: 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)
  • Diet in periods of early life
    • Time Frame: 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)

Secondary Measures

  • Breastfeeding duration in infancy and early childhood
    • Time Frame: 9, 18 and 36 months of age
    • Questionnaire used for assessment of exclusive and partially breastfeeding. Compare the duration with SKOT-I cohort (NCT02170428)
  • Insulin like growth factor at 9 and 36 months of age
    • Time Frame: 9 and 36 months of age
    • Insulin like growth factor-1 and insulin like growth factor binding protein-3 concentrations in plasma. Compare the measurements with those observed in SKOT-I (NCT02170428)
  • Physical activity, sedentary behavior and sleep in early childhood
    • Time Frame: 9, 18 and 36 months of age
    • Physical activity and sedentary behavior measured by ActiGrafph GT3X accelerometer, recording for 24 hours in 7 days at 36 months of age. Information on outdoor activity, sedentary behavior and night sleep are collected through questionnaires at 9, 18 and 36. months of age. Compare the measurements with those observed in SKOT-I (NCT02170428)
  • Vitamin D status in infancy
    • Time Frame: 9 and 36 months of age
    • 25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age. Compare the measurements with those observed in SKOT-I (NCT02170428)
  • Allergy and chronic diseases
    • Time Frame: 9 and 36 months of age
    • Assessment of diseases by questionnaires. Compare frequencies with those observed in SKOT-I (NCT02170428)
  • Appetite hormones in infancy
    • Time Frame: 9 and 36 months of age
    • Leptin and adiponectin concentrations measured from blood samples. Compare the measurements with those observed in SKOT-I (NCT02170428)
  • Change in gut microbiota
    • Time Frame: : 9, 18 and 36 months of age
    • Microbiota in the faeces analysed using polymerase chain reaction (PCR). Compare findings with SKOT-I (NCT02170428)
  • Achievement of milestones
    • Time Frame: 9 and 36 months of age
    • Achievement of age-specific milestones by questionnaires; WHO questionnaires at 9 and 36 months of age and Ages & Stages Questionnaires (ASQ) at 36 months of age. Compare findings with SKOT-I (NCT02170428)
  • Metabolomics in the urine
    • Time Frame: 9, 18 and 36 months of age
    • Metabolomics analysed using urine samples. Compare findings with SKOT-I (NCT02170428)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 9 Months

Maximum Age: 3 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Copenhagen
  • Collaborator
    • Technical University of Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Arne Astrup, Professor MD – University of Copenhagen
  • Overall Official(s)
    • Kim F Michaelsen, MD Professor, Principal Investigator, Faculty of Science, University of Copenhagen

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