Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

Brief 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

Condition or disease Intervention/treatment Phase
Reduce the Risk of Obesity During Infancy Reduce the Risk of Insulin Resistance Behavioral: advisory support Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : September 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: advisory support
advisory support for six months to prolong the breast-feeding period
Behavioral: advisory support
regular advisory support to the prolong breast-feeding period

Primary Outcome Measures :
  1. fat tissue [ Time Frame: 6 months ]
    weight skinfolds

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

Sick infants Preterm infants No consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01235663

Department of Neonatology, Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ole Pryds, MD, Hvidovre University Hospital Identifier: NCT01235663     History of Changes
Other Study ID Numbers: Breastfeeding-2650
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Ole Pryds, Hvidovre University Hospital:
obesity, insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Nutrition Disorders
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases