Bottle Design for Infant Weight Gain

(AB3 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Charles T Wood, MD, MPH

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Multiple gestation, Congenital anomaly, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment involving different bottle designs for infant weight gain?

Research suggests that larger bottle sizes are linked to faster weight gain in infants, and using opaque, weighted bottles may improve feeding outcomes by reducing overfeeding. This indicates that bottle design can influence infant weight gain. ^{1 2 3 4 5}

Is the bottle design for infant weight gain safe for use?

Some infant feeding bottles have inaccurate volume markers, which can lead to incorrect formula preparation and potentially cause serious illness or malnutrition. It's important to ensure bottles meet safety standards to avoid these risks. ^{1 3 4 5 6}

How does the bottle design treatment for infant weight gain differ from other treatments?

This treatment is unique because it explores how different bottle designs, such as clear versus opaque and small versus standard sizes, can influence infant feeding behaviors and weight gain. Unlike other treatments, it focuses on the physical characteristics of the bottle to potentially prevent overfeeding and promote healthier weight gain in infants. ^{1 2 3 4 5}

Research Team

Charles T Wood, MD, MPH

Principal Investigator

Duke University

Eligibility Criteria

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

My caregiver is at least 18 years old.

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

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

Trial Timeline

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

Treatment Details

Interventions

• Clear Bottle (Behavioral Intervention)
• Opaque Bottle (Behavioral Intervention)
• Small Bottle Size (Behavioral Intervention)
• Standard Bottle Size (Behavioral Intervention)

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.

Participant Groups

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+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Bottle Size and Weight Gain in Formula-Fed Infants. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Volume marker inaccuracies: A cross-sectional survey of infant feeding bottles. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Promoting Responsive Bottle-Feeding Within WIC: Evaluation of a Policy, Systems, and Environmental Change Approach. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Infant feeding bottle design, growth and behaviour: results from a randomised trial. [2021]