Back to resultsMinimizing the Risk for Obesity During Infancy by Extensive Advisory Service
Primary Purpose
Reduce the Risk of Obesity During Infancy, Reduce the Risk of Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
advisory support
Sponsored by
About this trial
This is an interventional prevention trial for Reduce the Risk of Obesity During Infancy focused on measuring obesity, insulin resistance
Eligibility Criteria
Inclusion Criteria:
Healthy, term infants Informed and written consent obtained from both parents -
Exclusion Criteria:
Sick infants Preterm infants No consent
-
Sites / Locations
- Department of Neonatology, Hvidovre University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
advisory support
Arm Description
advisory support for six months to prolong the breast-feeding period
Outcomes
Primary Outcome Measures
fat tissue
weight skinfolds
Secondary Outcome Measures
Full Information
NCT ID
NCT01235663
First Posted
November 4, 2010
Last Updated
March 17, 2015
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01235663
Brief Title
Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service
Official Title
Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduce the Risk of Obesity During Infancy, Reduce the Risk of Insulin Resistance
Keywords
obesity, insulin resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
advisory support
Arm Type
Experimental
Arm Description
advisory support for six months to prolong the breast-feeding period
Intervention Type
Behavioral
Intervention Name(s)
advisory support
Intervention Description
regular advisory support to the prolong breast-feeding period
Primary Outcome Measure Information:
Title
fat tissue
Description
weight skinfolds
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, term infants Informed and written consent obtained from both parents -
Exclusion Criteria:
Sick infants Preterm infants No consent
-
Facility Information:
Facility Name
Department of Neonatology, Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24004897
Citation
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.
Results Reference
derived
Learn more about this trial
Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service
We'll reach out to this number within 24 hrs