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

Obesity Clinical Trial

— SKOT II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377973
• Other study ID #: D209
• Secondary ID: H-3-2010-122
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: March 3, 2015
• Start date: January 2011
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 3 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Growth
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Overweight

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Faculty of Sciences, University of Copenhagen	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Hvidovre University Hospital, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Allergy and chronic diseases	Assessment of diseases by questionnaires. Compare frequencies with those observed in SKOT-I (NCT02170428)	9 and 36 months of age	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Metabolomics in the urine	Metabolomics analysed using urine samples. Compare findings with SKOT-I (NCT02170428)	9, 18 and 36 months of age	No

External Links

•   Study homepage