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Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235663
First Posted: November 5, 2010
Last Update Posted: March 19, 2015
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.
Information provided by (Responsible Party):
Ole Pryds, Hvidovre University Hospital
  Purpose

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 Intervention
Reduce the Risk of Obesity During Infancy Reduce the Risk of Insulin Resistance Behavioral: advisory support

Study Type: Interventional
Study Design: 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 ?

Resource links provided by NLM:


Further study details as provided by Ole Pryds, Hvidovre University Hospital:

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


Enrollment: 226
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

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

Exclusion Criteria:

Sick infants Preterm infants No consent

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01235663


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ole Pryds, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01235663     History of Changes
Other Study ID Numbers: Breastfeeding-2650
First Submitted: November 4, 2010
First Posted: November 5, 2010
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:
Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases