Diet and Well-being of Young Danish Children Born by Obese Mothers (SKOT II)

The SKOT II Cohort - a Prospective Cohort Study of Diet and Well-being in 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).

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Metabolic Syndrome; Growth

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).

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 1958
    • Department of Human Nutrition, Faculty of Sciences, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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,

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Growth and Development; Growth and Development og healthy young children born by Obese mothers

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Hvidovre University Hospital; Technical University of Denmark
• Investigators: Principal Investigator: Kim F Michaelsen, MD Professor, Faculty of Science, University of Copenhagen

Publications and helpful links

Helpful Links

• Study homepage

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 4, 2015

Study Record Updates

• Last Update Posted (Estimate): March 4, 2015
• Last Update Submitted That Met QC Criteria: March 3, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: physical activity; breastfeeding; children,; complementary feeding; growth,; tracking; infancy,; diet,; early life programming
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Overweight
• Other Study ID Numbers: D209; H-3-2010-122 (Other Identifier: The Committees on Biomedical Research Ethics for the Capital Region of Denmark)