Bottle Design for Infant Weight Gain

(AB3 Trial)

Overseen By Janna B Howard, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Multiple gestation, Congenital anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

76 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 6 7}

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

Caregiver must agree to use intervention bottles assigned during randomization and agree to stop using their existing bottles during the study period

My caregiver is at least 18 years old.

Greater than 37 weeks gestational age at birth

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive interventions with different bottle sizes and opacities to assess impact on infant weight gain

16 weeks

Regular in-home visits for video recordings and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clear Bottle
• Opaque Bottle
• Small Bottle Size
• Standard Bottle Size

Trial Overview The study tests how bottle size (small vs standard) and opacity (opaque vs clear) affect infant weight gain. It randomly assigns participants into groups combining these variables in a factorial design, meaning each group gets a different combination.

How Is the Trial Designed?

Group I: Standard, Opaque Experimental Treatment 2 Interventions

This group will receive standard-sized opaque bottles

Group II: Standard, Clear Experimental Treatment 2 Interventions

This group will receive standard-sized clear bottles

Group III: Small, Opaque Experimental Treatment 2 Interventions

This group will receive small-sized opaque bottles

Group IV: Small, Clear Experimental Treatment 2 Interventions

This group will receive small-sized clear bottles

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a study involving 40 parent-infant dyads, providing 4-ounce bottles was found to be feasible and acceptable, with 90% of participants using them at follow-up.

The intervention group using smaller bottles reported a significantly lower median bottle size compared to the control group, suggesting that smaller bottle sizes may help in managing infant feeding practices and potentially prevent rapid weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Feasibility and Acceptability of Providing Caregivers Who Formula-feed with Smaller Infant Bottles in a Primary Care Clinic. Wood, CT., Howard, JB., Perrin, EM.[2023]

Implementing policy, systems, and environmental (PSE) strategies in WIC clinics led to a significantly lower risk of rapid weight gain (RWG) in bottle-fed infants, as evidenced by a matched-pair cluster randomized trial involving 246 mothers and their newborns.

Mothers in PSE clinics reported feeling better supported in their bottle-feeding decisions and showed more stable intentions to continue in the WIC program, suggesting that these strategies not only impacted infant weight outcomes but also improved maternal experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Responsive Bottle-Feeding Within WIC: Evaluation of a Policy, Systems, and Environmental Change Approach. Ventura, AK., Silva Garcia, K., Meza, M., et al.[2022]

A study of 91 infant feeding bottles in Australia found that 22% had inaccurate volume markings, which can lead to serious health risks like malnutrition or obesity due to improper formula concentration.

Bottles claiming compliance with European standards were not necessarily more accurate, and particularly inaccurate were disposable liner systems, suggesting a need for stricter regulations and better guidance for safe infant formula preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volume marker inaccuracies: A cross-sectional survey of infant feeding bottles. Gribble, K., Berry, N., Kerac, M., et al.[2020]

In a study involving 386 formula-fed infants, those fed with large bottles (≥6 oz) experienced significantly greater weight gain and changes in weight-for-age and weight-for-length z scores compared to those using regular bottles (<6 oz).

The findings suggest that bottle size is a modifiable risk factor for rapid weight gain in infants, indicating that using smaller bottles may help prevent obesity in exclusively formula-fed infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bottle Size and Weight Gain in Formula-Fed Infants. Wood, CT., Skinner, AC., Yin, HS., et al.[2023]

Using opaque, weighted bottles for feeding infants led to mothers being more sensitive to their infants' cues and resulted in lower feeding rates and less milk intake per kilogram of body weight, suggesting better feeding practices.

The study involved 76 mothers feeding their infants from both opaque and clear bottles, and the findings indicate that opaque bottles may help improve the quality of bottle-feeding interactions, especially for infants who show clear feeding cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of opaque, weighted bottles on maternal sensitivity and infant intake. Ventura, AK., Hernandez, A.[2020]

In a study of 63 healthy, exclusively formula-fed infants, there was no significant difference in weight gain between those using two different bottle designs (Philips Avent vs. Dr. Browns) over a 4-week period.

Infants using the Philips Avent bottle reported significantly less fussing compared to those using the Dr. Browns bottle, suggesting that bottle design may influence infant behavior, although no differences were found in milk intake or growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant feeding bottle design, growth and behaviour: results from a randomised trial. Fewtrell, MS., Kennedy, K., Nicholl, R., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4925078/

Bottle Size and Weight Gain in Formula-Fed Infants - PMC CONCLUSIONS: Using a large bottle in early infancy independently contributed to greater weight gain and change in WLZ at the 6-month visit. Although growth in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2212267224000558

A Pilot Feasibility Randomized Controlled Trial of Effects ... Although preliminary, study findings suggest the potential of opaque bottles to support healthier weight outcomes for bottle-fed infants. Previous article in ...

3. publications.aap.org publications.aap.org/journal-blogs/blog/4158/Of-Bottles-Babies-and-Obesity

Of Bottles, Babies and Obesity | AAP Journal Blogs And yes, bottle size at 2 months of age did make a difference in weight for age and weight for length at 6 months of age, even after adjustment ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7199074/

Effects of opaque, weighted bottles on maternal sensitivity and ... The present study assessed whether use of opaque, weighted bottles (as compared with conventional, clear bottles) improves feeding outcomes.

5. jandonline.org jandonline.org/article/S2212-2672(24)00055-8/pdf

research Although preliminary, study findings suggest the potential of opaque bottles to support healthier weight outcomes for bottle-fed infants. J Acad Nutr Diet. 2024 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7083444/

Bottle‐feeding an infant feeding modality The findings of this review revealed that healthy term bottle‐feeding infants use similar tongue and jaw movements, can create suction and sequentially use ...

7. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/1151630

Risk of Bottle-feeding for Rapid Weight Gain During the ... Among infants fed only breastmilk, monthly weight gain increased from 729 g when few feedings were by bottle to 780 g when most feedings were by bottle.