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"Watch Your Baby Grow" Study (GRO)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700205
First Posted: October 4, 2012
Last Update Posted: June 7, 2017
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.
Collaborators:
University of Delaware
Children's Hospital of Philadelphia
University of Wisconsin, Madison
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center
  Purpose
The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.

Condition Intervention
Development Other: Type of Formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Impact of Diet Composition on Energy Balance and Satiety During Infancy

Resource links provided by NLM:


Further study details as provided by Julie A. Mennella, Monell Chemical Senses Center:

Primary Outcome Measures:
  • Growth and energy balance [ Time Frame: Infant age 2 weeks to 18 months ]
    Anthropometry z-scores (weight for age, length for age, head circumference for age, weight for length) obtained during monthly assessments for first 18 mos of life. All components of energy balance measured at 0.5, 3, and 12 months


Secondary Outcome Measures:
  • Intake and feeding behaviors [ Time Frame: Infant age 2 weeks to 18 months ]
    Intake and satiety behaviors measured during infant-led feeding conditions. Maternal reports of infant dietary history and maternal perception of infant behavior, using standardized questionnaires, will also be obtained.

  • Genotype [ Time Frame: 2wks-18 months ]
    Saliva and stool samples will be collected and later genotyped.


Estimated Enrollment: 144
Actual Study Start Date: October 2012
Estimated Study Completion Date: December 2018
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Type of Formula: CMF
infant is randomized to feed standard cow milk formula during first year of life
Other: Type of Formula
infant formula
Other Names:
  • cow milk formula (CMF)
  • protein hydrolysate formula (EHF)
Experimental: Type of Formula: EHF
infant is randomized to feed extensively hydrolyzed infant formula during first year of life
Other: Type of Formula
infant formula
Other Names:
  • cow milk formula (CMF)
  • protein hydrolysate formula (EHF)

Detailed Description:
This is a randomized clinical trial of infants whose parents decided to formula feed them; mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The groups will differ in the composition of the formula fed to the infant during the first year of life.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria

  1. A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant.
  2. Birth weight between 2500 - 4500 grams.
  3. At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0).
  4. Mother must be 18 years or older.
  5. Infant must be consuming a standard cow's milk protein infant formula and have been receiving a standard cow's milk protein infant formula for at least the past 2 days prior to enrollment.

Exclusion Criteria

  1. Mother had gestational diabetes during pregnancy
  2. Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle.
  3. Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation).
  4. Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus).
  5. Infant has evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases. For example, infant must not be receiving insulin or growth hormone.
  6. Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study.
  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): NCT01700205


Locations
United States, Pennsylvania
Monell Chemical Senses Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Monell Chemical Senses Center
University of Delaware
Children's Hospital of Philadelphia
University of Wisconsin, Madison
Investigators
Principal Investigator: Julie A Mennella, PhD Monell Chemical Senses Center
Principal Investigator: Jillian Trabulsi, PhD University of Delaware
  More Information

Publications:
Responsible Party: Julie A. Mennella, Member, Monell Chemical Senses Center
ClinicalTrials.gov Identifier: NCT01700205     History of Changes
Other Study ID Numbers: HD072307
First Submitted: October 2, 2012
First Posted: October 4, 2012
Last Update Posted: June 7, 2017
Last Verified: June 2017

Keywords provided by Julie A. Mennella, Monell Chemical Senses Center:
Formula Feeding
Mother
Moms
Infants
Babies
Baby
growth
energy balance