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

NCT ID: NCT02377973

Last Updated: 2015-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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).

Conditions

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Growth Overweight Metabolic Syndrome Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Growth and Development

Growth and Development og healthy young children born by Obese mothers

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

9 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Denmark

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Arne Astrup

Professor MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kim F Michaelsen, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Science, University of Copenhagen

Locations

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Department of Human Nutrition, Faculty of Sciences, University of Copenhagen

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://skot.ku.dk

Study homepage

Other Identifiers

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H-3-2010-122

Identifier Type: OTHER

Identifier Source: secondary_id

D209

Identifier Type: -

Identifier Source: org_study_id

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