NCT06357299

Assessing Better Bottles for Babies

Assessing Better Bottles for Babies (AB3)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 3 Days – 1 Month
• Healthy volunteers: Not accepted

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.

Detailed description

Infants who gain weight rapidly have over 4 times higher odds of developing obesity as a child or adult; infants who are predominantly bottle-fed are at higher risk for excessive infancy weight gain and childhood obesity, yet there are not effective interventions to reduce excessive weight gain among infants who are bottle-fed. The investigators' preliminary work suggest that two novel intervention strategies are feasible and may reduce excessive infancy weight gain: reducing bottle size; and increasing bottle opacity. The investigators aim to test the independent and joint efficacy of these two intervention components among exclusively bottle-fed infants in a randomized, full factorial clinical trial. The investigators' primary objective is to measure the change in conditional weight gain z-score (CWGz) from birth to four months by study group. 4 groups are composed of two conditions: smaller bottles and opaque bottles, independently and in combination, via a 2x2 factorial trial design.

Conditions

• Pediatric Obesity
• Weight Gain Trajectory
• Infant Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Small Bottle Size	Small sized bottle
BEHAVIORAL	Standard Bottle Size	Standard sized bottle
BEHAVIORAL	Clear Bottle	Clear bottle
BEHAVIORAL	Opaque Bottle	Opaque bottle

Timeline

• Start date: 2025-05-28
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-04-10
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States