Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ole Pryds, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01235663
First received: November 4, 2010
Last updated: March 17, 2015
Last verified: March 2015

November 4, 2010
March 17, 2015
September 2010
December 2012   (final data collection date for primary outcome measure)
fat tissue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
 
Completed
226
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

Both
up to 3 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01235663
Breastfeeding-2650
No
Not Provided
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Ole Pryds, Hvidovre University Hospital
Hvidovre University Hospital
Not Provided
Not Provided
Hvidovre University Hospital
March 2015

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