Bottle Design for Infant Weight Gain
(AB3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different bottle designs might affect infant weight gain, specifically examining the impact of clear versus opaque bottles and small versus standard sizes. Eligible infants are those aged 3 days to 1 month, born after 37 weeks of pregnancy, and weighing above the lowest 3% for their age group. Caregivers must agree to use the provided bottles and visit a local clinic regularly for the first six months. The trial aims to determine if changing bottle design can enhance infant growth. As an unphased study, it offers a unique opportunity to contribute to research that could improve infant nutrition and growth.
Do I have to stop my baby's current bottles for the trial?
Yes, you will need to stop using your current bottles and use the intervention bottles assigned during the study.
What prior data suggests that these bottle designs are safe for infants?
Research has shown that opaque bottles might support healthier weight outcomes for babies. In some studies, mothers using opaque bottles became more aware of their baby's hunger signals and fed them more slowly.
Regarding bottle size, studies suggest that larger bottles can lead to more weight gain in babies, while smaller bottles might help prevent early-childhood obesity. Although these findings are still early, they reveal some patterns.
Overall, these bottle designs are practical and have been generally well-received in trials. No significant negative effects have been reported from using these types of bottles, suggesting they should be safe for use in the study.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how different bottle designs might influence infant weight gain. Unlike current feeding options, which typically focus on the type of formula or feeding schedule, this study looks at the physical attributes of bottles, such as size and transparency. By examining whether clear versus opaque or small versus standard-sized bottles impact how much infants consume, this trial could provide new insights into feeding strategies that optimize infant growth. This approach is unique as it considers the feeding vessel as a factor in nutrition, something not typically emphasized in standard care.
What evidence suggests that this trial's bottle designs could be effective for infant weight gain?
This trial will compare different bottle designs to assess their impact on infant weight gain. Research has shown that opaque bottles can support healthier weight in bottle-fed babies. Studies have found that mothers using opaque bottles pay more attention to their babies' signals and feed them more slowly. This can lead to babies drinking less milk, which may help prevent excessive weight gain. However, research also indicates that larger bottles, whether clear or opaque, often result in more weight gain in babies. In this trial, some participants will receive standard-sized opaque or clear bottles, while others will receive small-sized opaque or clear bottles. Smaller bottles, especially if opaque, might better promote healthy weight gain.13467
Who Is on the Research Team?
Charles T Wood, MD, MPH
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for caregivers of infants aged 3 days to 1 month, who speak English or Spanish, with newborns above the 3rd percentile in birth weight and born after at least 37 weeks of pregnancy. Caregivers must be over 18 and plan to use a specific local clinic. They need to agree to only use the study's bottles.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive interventions with different bottle sizes and opacities to assess impact on infant weight gain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Clear Bottle
- Opaque Bottle
- Small Bottle Size
- Standard Bottle Size
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
National Institutes of Health (NIH)
Collaborator