Diet and Well-being of Young Danish Children Born by Obese Mothers (SKOT II)
3. März 2015 aktualisiert von: Arne Astrup, University of Copenhagen
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).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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).
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
184
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Frederiksberg, Dänemark, 1958
- Department of Human Nutrition, Faculty of Sciences, University of Copenhagen
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
9 Monate bis 3 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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,
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Growth and Development
Growth and Development og healthy young children born by Obese mothers
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in anthropometric measurements in periods of early childhood
Zeitfenster: 9, 18 and 36 months of age
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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)
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9, 18 and 36 months of age
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Body composition in early childhood
Zeitfenster: 36 months of age
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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)
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36 months of age
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Markers of Metabolic syndrome in early life
Zeitfenster: 9 and 36 months of age
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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)
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9 and 36 months of age
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Diet in periods of early life
Zeitfenster: 9, 18 and 36 months of age
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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)
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9, 18 and 36 months of age
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Breastfeeding duration in infancy and early childhood
Zeitfenster: 9, 18 and 36 months of age
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Questionnaire used for assessment of exclusive and partially breastfeeding.
Compare the duration with SKOT-I cohort (NCT02170428)
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9, 18 and 36 months of age
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Insulin like growth factor at 9 and 36 months of age
Zeitfenster: 9 and 36 months of age
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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)
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9 and 36 months of age
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Physical activity, sedentary behavior and sleep in early childhood
Zeitfenster: 9, 18 and 36 months of age
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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)
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9, 18 and 36 months of age
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Vitamin D status in infancy
Zeitfenster: 9 and 36 months of age
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25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age.
Compare the measurements with those observed in SKOT-I (NCT02170428)
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9 and 36 months of age
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Allergy and chronic diseases
Zeitfenster: 9 and 36 months of age
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Assessment of diseases by questionnaires.
Compare frequencies with those observed in SKOT-I (NCT02170428)
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9 and 36 months of age
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Appetite hormones in infancy
Zeitfenster: 9 and 36 months of age
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Leptin and adiponectin concentrations measured from blood samples.
Compare the measurements with those observed in SKOT-I (NCT02170428)
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9 and 36 months of age
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Change in gut microbiota
Zeitfenster: : 9, 18 and 36 months of age
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Microbiota in the faeces analysed using polymerase chain reaction (PCR).
Compare findings with SKOT-I (NCT02170428)
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: 9, 18 and 36 months of age
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Achievement of milestones
Zeitfenster: 9 and 36 months of age
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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)
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9 and 36 months of age
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Metabolomics in the urine
Zeitfenster: 9, 18 and 36 months of age
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Metabolomics analysed using urine samples.
Compare findings with SKOT-I (NCT02170428)
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9, 18 and 36 months of age
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Kim F Michaelsen, MD Professor, Faculty of Science, University of Copenhagen
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2011
Primärer Abschluss (Tatsächlich)
1. Februar 2015
Studienabschluss (Tatsächlich)
1. Februar 2015
Studienanmeldedaten
Zuerst eingereicht
27. Februar 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. März 2015
Zuerst gepostet (Schätzen)
4. März 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
4. März 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. März 2015
Zuletzt verifiziert
1. Februar 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- D209
- H-3-2010-122 (Andere Kennung: The Committees on Biomedical Research Ethics for the Capital Region of Denmark)
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