"Watch Your Baby Grow" Study (GRO)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
|Official Title:||Impact of Diet Composition on Energy Balance and Satiety During Infancy|
- Growth and energy balance [ Time Frame: Infant age 2 weeks to 18 months ] [ Designated as safety issue: No ]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
- Intake and feeding behaviors [ Time Frame: Infant age 2 weeks to 18 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Saliva and stool samples will be collected and later genotyped.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Type of Formula: CMF
infant is randomized to feed standard cow milk formula during first year of life
Other: Type of Formula
Experimental: Type of Formula: ePHF
infant is randomized to feed extensively hydrolyzed infant formula during first year of life
Other: Type of Formula
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700205
|United States, Pennsylvania|
|Monell Chemical Senses Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Julie A Mennella, PhD||Monell Chemical Senses Center|
|Principal Investigator:||Jillian Trabulsi, PhD||University of Delaware|