Testing bottle sizes and opacity to reduce infant weight gain
Assessing Better Bottles for Babies (AB3)
This study is testing if using smaller or opaque bottles can help bottle-fed infants gain less weight and lower their chances of becoming overweight later on.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 3 Days to 1 Month |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06357299 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two intervention strategies—bottle size and bottle opacity—on weight gain in infants who are exclusively bottle-fed. Using a 2 x 2 factorial design, the trial will randomly assign infants to one of four groups: small or standard bottle size, and clear or opaque bottles. The primary goal is to measure changes in weight gain z-scores from birth to four months, aiming to identify effective methods to prevent excessive weight gain and reduce the risk of childhood obesity. The study is particularly focused on infants who are at a higher risk of rapid weight gain.
Who should consider this trial
Good fit: Ideal candidates are infants aged 3 days to 1 month who are exclusively bottle-fed and meet specific health criteria.
Not a fit: Patients who are born from multiple gestations or have significant congenital anomalies affecting growth will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective strategies to prevent excessive weight gain in bottle-fed infants, potentially reducing the risk of obesity later in life.
How similar studies have performed: While there is limited research on this specific approach, preliminary work suggests that these intervention strategies may be feasible and effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Charles T Wood, MD, MPH — Duke University
- Study coordinator: Janna B Howard, MPH
- Email: janna.howard@duke.edu
- Phone: 919-620-4793
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.