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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02377973
Acronym
SKOT II
Enrollment
184
Registered
2015-03-04
Start date
2011-01-31
Completion date
2015-02-28
Last updated
2015-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth, Metabolic Syndrome, Obesity, Overweight

Keywords

growth,, infancy,, children,, diet,, breastfeeding, complementary feeding, early life programming, tracking, physical activity

Brief 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).

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).

Interventions

None listed

Sponsors

Technical University of Denmark
CollaboratorOTHER
Hvidovre University Hospital
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Months to 3 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in anthropometric measurements in periods of early childhood9, 18 and 36 months of ageComposite 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 childhood36 months of ageBody 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 life9 and 36 months of ageMarkers 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 life9, 18 and 36 months of ageThe 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

MeasureTime frameDescription
Allergy and chronic diseases9 and 36 months of ageAssessment of diseases by questionnaires. Compare frequencies with those observed in SKOT-I (NCT02170428)
Appetite hormones in infancy9 and 36 months of ageLeptin and adiponectin concentrations measured from blood samples. Compare the measurements with those observed in SKOT-I (NCT02170428)
Breastfeeding duration in infancy and early childhood9, 18 and 36 months of ageQuestionnaire used for assessment of exclusive and partially breastfeeding. Compare the duration with SKOT-I cohort (NCT02170428)
Achievement of milestones9 and 36 months of ageAchievement 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 urine9, 18 and 36 months of ageMetabolomics analysed using urine samples. Compare findings with SKOT-I (NCT02170428)
Change in gut microbiota: 9, 18 and 36 months of ageMicrobiota in the faeces analysed using polymerase chain reaction (PCR). Compare findings with SKOT-I (NCT02170428)
Insulin like growth factor at 9 and 36 months of age9 and 36 months of ageInsulin 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 childhood9, 18 and 36 months of agePhysical 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 infancy9 and 36 months of age25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age. Compare the measurements with those observed in SKOT-I (NCT02170428)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026