Bottle Nipples for Infants of Mothers with Obesity

Overseen By Amanda Crandall, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Non-PLAN study, Low birth weight, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how babies react to different bottle nipple sizes, specifically those with larger or smaller holes. Researchers believe infants of mothers with obesity who did not lose weight before pregnancy might respond differently to these nipple types. Two groups participate: one group tries the typical nipple first, then the challenging one, while the other group does the opposite. Mothers who previously participated in the PLAN study and have infants aged 3 to 6 months who consume from a bottle at least once a week might be a good fit for this study. As an unphased study, this trial offers a unique opportunity to contribute to understanding infant feeding behaviors.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these bottle nipples are safe for infants?

Research shows that bottle-feeding is common for infants, and many studies have explored its effects. This study examines how the size of the holes in bottle nipples, whether larger or smaller, affects feeding.

While bottle nipples are generally safe, this study investigates their interaction with factors like the mother's health, such as obesity. Although no direct evidence suggests safety issues with the nipples used in this study, researchers aim to understand their impact on feeding in infants of mothers with obesity.

For those considering participation, it's important to know that bottle-feeding is normal, and these studies aim to improve understanding rather than highlight major risks. Always consult a healthcare provider if specific concerns arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different bottle nipple sequences might affect feeding in infants whose mothers have obesity. Unlike typical feeding studies, this trial examines the order in which infants are exposed to typical versus challenging nipples. This unique approach could reveal important insights into feeding behaviors and preferences in infants, potentially leading to better feeding strategies for infants of mothers with obesity. By understanding how nipple type and sequence impact feeding, researchers hope to improve infant nutrition and overall health outcomes.

What evidence suggests that this trial's treatments could be effective?

Research has shown that bottle-feeding can affect how babies eat, particularly when their mothers have obesity. This trial will compare two different nipple designs to understand their impact on infant feeding. Studies have found that the size of the hole in the bottle nipple can change how fast a baby drinks. Larger holes can lead to faster feeding, which might cause babies to gain weight more quickly. This poses a concern for babies at risk of becoming overweight. Additionally, babies who are bottle-fed more often may have a higher chance of becoming obese as they grow up. Understanding how different nipple designs affect feeding can help improve feeding habits and possibly lower the risk of obesity. ^{1 2 3 6 7}

Who Is on the Research Team?

Julie Lumeng, MD

Principal Investigator

University of Michigan

Amanda Crandall, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This study is for babies aged 3 to 6 months who are typically bottle-fed and have birth weights within the normal range. Their mothers must be their full-time legal guardians, not shared custody, and should have been part of the PLAN study during pregnancy but did not lose weight before giving birth.

Inclusion Criteria

Infant birth weight is appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set

Stated willingness by mother to comply with all study procedures and availability for the duration of the study.

Mother has not participated in the PLAN study resulting in a live birth

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants are exposed to different nipple types to measure sucking behavior

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pre-Pregnancy Weight Loss

Trial Overview The trial is examining how infants react to two types of bottle nipples: one with a standard hole size (typical nipple) and another with a smaller or larger hole (challenging nipple). The focus is on whether there's a 'Suck Effect' difference in babies whose mothers had obesity and didn't lose weight pre-pregnancy.

How Is the Trial Designed?

Group I: Nipple order 2 Experimental Treatment 2 Interventions

First the challenging nipple and then the typical nipple

Group II: Nipple order 1 Experimental Treatment 2 Interventions

First the typical nipple and then challenging nipple

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. withpower.com withpower.com/trial/phase-pregnancy-related-3-2024-7064c

Bottle Nipples for Infants of Mothers with Obesity This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers ...

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

Bottle‐feeding an infant feeding modality: An integrative ... Bottle‐feeding outcomes are connected to both mother and infant factors. Characteristics such as race, ethnicity, and obesity influence feeding practices.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0195666325003137

Infant feeding behavior development to 12 months with ... Indeed, a greater proportion of feedings from an artificial nipple (i.e., greater bottle-feeding intensity) is associated with more rapid weight gain during ...

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

research Given recent bottle-feeding interventions focused on educating parents have shown little success in modifying feeding behaviors or weight gain outcomes,29-32 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32498550/

Associations between Bottle-Feeding during Infancy and ... Conclusions: Rapid increases in bottle use during the first 6 months postpartum predicted greater risk for obesity at age 6 years via an ...

6. fda.gov fda.gov/food/social-and-behavioral-science-research-food/consumer-research-infant-formula-and-infant-feeding

Consumer Research on Infant Formula and Infant Feeding 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 ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/rfc2.70002

Prevalence of Bottle‐Feeding Practice and Associated ... This study aims to assess the prevalence and determinants of bottle feeding among mothers of children under five globally.