Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Ole Pryds, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT01235663

First received: November 4, 2010

Last updated: September 24, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 4, 2010
Last Updated Date	September 24, 2012
Start Date ^ICMJE	September 2010
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 4, 2010)	fat tissue [ Time Frame: 6 months ] [ Designated as safety issue: No ] weight skinfolds
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01235663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service
Official Title ^ICMJE	Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?
Brief Summary	0-hypothesis: advisory support does not prolong the the breast-feeding period minimize the risk of obesity and metabolic dysfunction in infants of obese mothers
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Reduce the Risk of Obesity During Infancy Reduce the Risk of Insulin Resistance
Intervention ^ICMJE	Behavioral: advisory support regular advisory support to the prolong breast-feeding period
Study Arm (s)	Experimental: advisory support advisory support for six months to prolong the breast-feeding period Intervention: Behavioral: advisory support
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	December 2012
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy, term infants Informed and written consent obtained from both parents - Exclusion Criteria: Sick infants Preterm infants No consent -
Gender	Both
Ages	up to 3 Days
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01235663
Other Study ID Numbers ^ICMJE	Breastfeeding-2650
Has Data Monitoring Committee	No
Responsible Party	Ole Pryds, Hvidovre University Hospital
Study Sponsor ^ICMJE	Hvidovre University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hvidovre University Hospital
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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