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NCT01235663 Clinical Trial

Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service

Reduce the Risk of Insulin Resistance Clinical Trial

Official title:
Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01235663
Other study ID # Breastfeeding-2650
Secondary ID
Status Completed
Phase N/A
First received November 4, 2010
Last updated March 17, 2015
Start date September 2010
Est. completion date December 2013

Study information
Verified date March 2015
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 226
Est. completion date December 2013
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 3 Days
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Sick infants Preterm infants No consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• advisory support
regular advisory support to the prolong breast-feeding period

Locations
Country Name City State
Denmark Department of Neonatology, Hvidovre University Hospital Hvidovre

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary fat tissue weight skinfolds 6 months No