Infant Obesity, Pediatric Obesity, Weight Gain Trajectory
Conditions
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.
Interventions
BEHAVIORALSmall Bottle Size
Small sized bottle
BEHAVIORALStandard Bottle Size
Standard sized bottle
BEHAVIORALClear Bottle
Clear bottle
BEHAVIORALOpaque Bottle
Opaque bottle
Sponsors
Duke University
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2x2 factorial design
Eligibility
Sex/Gender
ALL
Age
3 Days to 1 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conditional weight gain z-score changes (CWGz) | 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
| Measure | Time frame | Description |
|---|---|---|
| Formula volume per feed | 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. |
| Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCharles T Wood, MD, MPH
Duke University
Outcome results
None listed