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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Hvidovre University Hospital:

Primary Outcome Measures:
  • fat tissue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    weight skinfolds


Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated 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

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235663

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

No publications provided

Responsible Party: Ole Pryds, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01235663     History of Changes
Other Study ID Numbers: Breastfeeding-2650
Study First Received: November 4, 2010
Last Updated: September 24, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by 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

ClinicalTrials.gov processed this record on October 19, 2014