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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Small sized bottle
Standard sized bottle
Clear bottle
Duke University
Durham, North Carolina, United States
RECRUITINGConditional weight gain z-score changes (CWGz)
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.
Time frame: Birth to 4 months
Formula volume per feed
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.
Time frame: Birth to 4 months
Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS)
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.
Time frame: Birth to 4 months
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Opaque bottle