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Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service

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ClinicalTrials.gov Identifier: NCT01235663
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : March 19, 2015
Information provided by (Responsible Party):
Ole Pryds, Hvidovre University Hospital

November 4, 2010
November 5, 2010
March 19, 2015
September 2010
December 2012   (Final data collection date for primary outcome measure)
fat tissue [ Time Frame: 6 months ]
weight skinfolds
Same as current
Complete list of historical versions of study NCT01235663 on ClinicalTrials.gov Archive Site
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Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service
Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?

0-hypothesis: advisory support does not

  1. prolong the the breast-feeding period
  2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Reduce the Risk of Obesity During Infancy
  • Reduce the Risk of Insulin Resistance
Behavioral: advisory support
regular advisory support to the prolong breast-feeding period
Experimental: advisory support
advisory support for six months to prolong the breast-feeding period
Intervention: Behavioral: advisory support
Carlsen EM, Kyhnaeb A, Renault KM, Cortes D, Michaelsen KF, Pryds O. Telephone-based support prolongs breastfeeding duration in obese women: a randomized trial. Am J Clin Nutr. 2013 Nov;98(5):1226-32. doi: 10.3945/ajcn.113.059600. Epub 2013 Sep 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy, term infants Informed and written consent obtained from both parents -

Exclusion Criteria:

Sick infants Preterm infants No consent

Sexes Eligible for Study: All
up to 3 Days   (Child)
Contact information is only displayed when the study is recruiting subjects
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Ole Pryds, Hvidovre University Hospital
Hvidovre University Hospital
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Hvidovre University Hospital
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP