Assessing Better Bottles for Babies (AB3)

Duke University

Status: Enrolling

Conditions: Weight Gain Trajectory; Pediatric Obesity; Infant Obesity

Treatments: Behavioral: Clear Bottle; Behavioral: Small Bottle Size; Behavioral: Opaque Bottle; Behavioral: Standard Bottle Size

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06357299

Pro00115060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 3 days to 1 month old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

Standard, Clear

Experimental group

Description:

This group will receive standard-sized clear bottles

Treatment:

Behavioral: Standard Bottle Size

Behavioral: Clear Bottle

Standard, Opaque

Experimental group

Description:

This group will receive standard-sized opaque bottles

Treatment:

Behavioral: Standard Bottle Size

Behavioral: Opaque Bottle

Small, Clear

Experimental group

Description:

This group will receive small-sized clear bottles

Treatment:

Behavioral: Small Bottle Size

Behavioral: Clear Bottle

Small, Opaque

Experimental group

Description:

This group will receive small-sized opaque bottles

Treatment:

Behavioral: Opaque Bottle

Behavioral: Small Bottle Size