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Completed

NCT Number: NCT02377973

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

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).

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Key information

Conditions

Growth Behavior Body Weight Breast Feeding Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

9 month–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Human Nutrition, Faculty of Sciences, University of Copenhagen

Frederiksberg, 1958, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. Metabolomics in the urine

    Time frame: 9, 18 and 36 months of age

    Metabolomics analysed using urine samples. Compare findings with SKOT-I (NCT02170428)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Hvidovre University Hospital
  • Technical University of Denmark

Registry information

Official study title

The SKOT II Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children Born by Obese Mothers

Acronym: SKOT II

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2015
Registry last updated
Mar 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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