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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Growth, Overweight, Metabolic Syndrome, Obesity

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Growth and Development<br>Growth and Development og healthy young children born by Obese mothers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anthropometric measurements in periods of early childhood | 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) | 9, 18 and 36 months of age | 
| Body composition in early childhood | 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) | 36 months of age | 
| Markers of Metabolic syndrome in early life | 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) | 9 and 36 months of age | 
| Diet in periods of early life | 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) | 9, 18 and 36 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding duration in infancy and early childhood | Questionnaire used for assessment of exclusive and partially breastfeeding. Compare the duration with SKOT-I cohort (NCT02170428) | 9, 18 and 36 months of age | 
| Insulin like growth factor at 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) | 9 and 36 months of age | 
| Physical activity, sedentary behavior and sleep in early childhood | 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) | 9, 18 and 36 months of age | 
| Vitamin D status in infancy | 25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age. Compare the measurements with those observed in SKOT-I (NCT02170428) | 9 and 36 months of age | 
| Allergy and chronic diseases | Assessment of diseases by questionnaires. Compare frequencies with those observed in SKOT-I (NCT02170428) | 9 and 36 months of age | 
| Appetite hormones in infancy | Leptin and adiponectin concentrations measured from blood samples. Compare the measurements with those observed in SKOT-I (NCT02170428) | 9 and 36 months of age | 
| Change in gut microbiota | Microbiota in the faeces analysed using polymerase chain reaction (PCR). Compare findings with SKOT-I (NCT02170428) | : 9, 18 and 36 months of age | 
| Achievement of milestones | 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 and 36 months of age | 
| Metabolomics in the urine | Metabolomics analysed using urine samples. Compare findings with SKOT-I (NCT02170428) | 9, 18 and 36 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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growth,, infancy,, children,, diet,, breastfeeding, complementary feeding, early life programming, tracking, physical activity