Diet and Well-being of Young Danish Children Born by Obese Mothers (SKOT II)
3. marts 2015 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
184
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Frederiksberg, Danmark, 1958
- Department of Human Nutrition, Faculty of Sciences, University of Copenhagen
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
9 måneder til 3 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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,
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Growth and Development
Growth and Development og healthy young children born by Obese mothers
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in anthropometric measurements in periods of early childhood
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Breastfeeding duration in infancy and early childhood
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: : 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kim F Michaelsen, MD Professor, Faculty of Science, University of Copenhagen
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2011
Primær færdiggørelse (Faktiske)
1. februar 2015
Studieafslutning (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først indsendt
27. februar 2015
Først indsendt, der opfyldte QC-kriterier
3. marts 2015
Først opslået (Skøn)
4. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. marts 2015
Sidst verificeret
1. februar 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D209
- H-3-2010-122 (Anden identifikator: The Committees on Biomedical Research Ethics for the Capital Region of Denmark)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .