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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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 with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple.

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 data supports the effectiveness of the treatment Pre-Pregnancy Weight Loss for improving breastfeeding outcomes in mothers with obesity?

Research indicates that maternal obesity is linked to challenges in breastfeeding, such as lower intention to breastfeed, reduced initiation and duration, and inadequate milk supply. Pre-pregnancy weight loss could potentially improve these outcomes by addressing the negative effects of obesity on breastfeeding success. ^{1 2 3 4 5}

How does the treatment of pre-pregnancy weight loss differ from other treatments for breastfeeding difficulties in mothers with obesity?

Pre-pregnancy weight loss is unique because it focuses on reducing a mother's weight before pregnancy to improve breastfeeding outcomes, unlike other treatments that address issues after childbirth. This approach aims to prevent problems like delayed milk production and early breastfeeding cessation by managing weight-related factors beforehand. ^{1 2 6 7 8}

Research Team

Julie Lumeng, MD

Principal Investigator

University of Michigan

Amanda Crandall, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Does maternal obesity adversely affect breastfeeding initiation and duration? [2004]

2. Australia pubmed.ncbi.nlm.nih.gov

Does maternal obesity adversely affect breastfeeding initiation and duration? [2022]

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

Early Breastfeeding Problems Mediate the Negative Association between Maternal Obesity and Exclusive Breastfeeding at 1 and 2 Months Postpartum. [2023]

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

Maternal obesity and breastfeeding intention, initiation, intensity and duration: a systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pre-gestational excessive weight and duration of breast-feeding. [2023]

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

Breastfeeding Difficulties, Breastfeeding Duration, Maternal Body Mass Index, and Breast Anatomy: Are They Related? [2020]

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

Lactation complicated by overweight and obesity: supporting the mother and newborn. [2021]

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

Prepregnancy Body Mass Index Shift Across Gestation: An Association with Breastfeeding Practices? [2022]