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Active Not Recruiting
NCT06357299
Assessing Better Bottles for Babies
Conditions: Pediatric Obesity, Weight Gain Trajectory, Infant Obesity
Sex: All
Ages: 3 Days – 1 Month
Healthy volunteers: No
Phase: NA
Enrollment: 5
Sponsor: Duke University
Location: Duke University Durham North Carolina
Summary
This study will use a 2 x 2 factorial design to test impact of two intervention strategies (bottle size and bottle opacity) on infant weight gain.
Eligibility Criteria
Inclusion Criteria:
* Child is 3 days old to 1 month old
* Greater than 37 weeks gestational age at birth
* Birth weight greater than 3% for sex-specific WHO growth standard
* Caregiver must plan to use local clinic as infant's primary medical home for first 6 months of life
* Caregiver must speak English or Spanish as primary preferred language
* Caregiver age 18 years or older
* Caregiver must agree to use intervention bottles assigned during randomization and agree to stop using their existing bottles during the study period
Exclusion Criteria:
* Multiple gestation
* Significant congenital anomaly or acquired or inherited condition directly affecting feeding, physiology, metabolism, or growth
* Feeding with soy-based, hydrolyzed, lactose-reduced, or elemental formula
* Weight loss greater than 95% for population reference in the first two weeks of life
Source: ClinicalTrials.gov (NCT06357299). StuddyBuddy aggregates publicly available trial information.