Percent Body Fat in Breast Fed Infants (PeaPod)

This study has been completed.
Sponsor:
Collaborators:
University of Arkansas
USDA Beltsville Human Nutrition Research Center
Life Measurement Inc.
University of Oklahoma
MetroHealth Medical Center
University of Milan
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00616083
First received: February 5, 2008
Last updated: August 19, 2009
Last verified: August 2009
  Purpose

The purpose of this study is to learn about normal body composition (% body fat) during the first six months of life in healthy breast-fed babies.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing Normative Body Composition Data in Early Infancy

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Enrollment: 190
Study Start Date: April 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Healthy breast fed infants

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Helathy breast fed infats, less than a week old living in the Little Rock area.

Criteria

Inclusion Criteria:

  • Term birth
  • Infant must weigh at least 5.5# at birth
  • Single birth
  • Healthy mother/infant as determined by the investigator
  • Intention to breast feed

Exclusion Criteria:

  • Significant perinatal morbidity
  • Having health, environmental, or economic constraints on growth
  • Infants of a mother with diabetes or gestational diabetes
  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: NCT00616083

Locations
United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
Italy
Universita degli Studi di Milano
Milano, Italy
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
University of Arkansas
USDA Beltsville Human Nutrition Research Center
Life Measurement Inc.
University of Oklahoma
MetroHealth Medical Center
University of Milan
Investigators
Principal Investigator: Aline Andres, Ph.D. University of Arkansas
  More Information

No publications provided

Responsible Party: Aline Andres, Ph.D / Principal Investiagor, University of Arkansas for Medical Science
ClinicalTrials.gov Identifier: NCT00616083     History of Changes
Other Study ID Numbers: 56991
Study First Received: February 5, 2008
Last Updated: August 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
Breast Feeding
Body Composition
Body Fat
Infant
Diet
Healthy Infants

ClinicalTrials.gov processed this record on September 18, 2014