Clinical trial NCT06357299: Assessing Better Bottles for Babies
Official title: Assessing Better Bottles for Babies (AB3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Weight Gain Trajectory
Infant Obesity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-04-10
Enrollment: 76
Sex: ALL
Minimum age (years): 3
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial design
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Conditional weight gain z-score changes (CWGz)
timeFrame: Birth to 4 months
Secondary outcomes:
measure: Formula volume per feed
timeFrame: Birth to 4 months
measure: Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS)
timeFrame: Birth to 4 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Charles T Wood, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: