Pediatric Obesity Clinical Trial
— AB3Official title:
Assessing Better Bottles for Babies (AB3)
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.
Status | Not yet recruiting |
Enrollment | 76 |
Est. completion date | February 1, 2026 |
Est. primary completion date | February 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Days to 1 Month |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institutes of Health (NIH) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conditional 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. | Birth to 4 months | |
Secondary | 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. | Birth to 4 months | |
Secondary | 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 bheavior/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. | Birth to 4 months |
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