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Completed

NCT Number: NCT06357299

Assessing Better Bottles for Babies

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.

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Key information

Age range

3 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Small Bottle Size

Behavioral

Small sized bottle

Standard Bottle Size

Behavioral

Standard sized bottle

Clear Bottle

Behavioral

Clear bottle

Opaque Bottle

Behavioral

Opaque bottle

Primary outcomes

  1. Conditional weight gain z-score changes (CWGz)

    Time frame: Birth to 4 months

    CWGz scores will be calculated for each participant as the residual of the actual weight-for-age z-score at 4 months minus its predicted z-score from linear regression of the 4 month z-score on birth weight z-score. Intent-to-treat analyses will include regression models, stratified by sex, with CWGz score as the outcome.

Secondary outcomes

  1. Formula volume per feed

    Time frame: Birth to 4 months

    At the time of in-home video recordings, the volume per feed will be measured from the pre- and post-weight of bottles by a food-grade scale calibrated and accurate to the nearest 0.01g.

  2. Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS)

    Time frame: Birth to 4 months

    The Nursing Child Assessment Feeding Scale (NCAFS) measures discrete behaviors scored as "presence" or "absence" of each behavior/item. We will calculate feeding behavior scores on the "Sensitivity to Cues" subscale (score range 0 to 16) and "Responsiveness to Caregiver" subscale (score range 0 to 11). Score of 0 on a subscale means that none of the behaviors/items were observed, higher scores indicate more behaviors on the subscale were observed.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Assessing Better Bottles for Babies (AB3)

Acronym: AB3

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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