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Behavioral Intervention

Bottle Nipples for Infants of Mothers with Obesity

N/A
Waitlist Available
Led By Amanda Crandall, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand how babies of mothers with obesity, who did not lose weight before pregnancy, respond to bottle nipples with different hole sizes. Researchers believe that these infants will have a stronger sucking effect

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves feeding bottles with different nipple sizes, side effects may include potential frustration or difficulty in feeding if the baby struggles with the challenging nipple compared to the typical one.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Suck effect
Secondary study objectives
Sucking frequency
Sucking pressure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nipple order 2Experimental Treatment2 Interventions
First the challenging nipple and then the typical nipple
Group II: Nipple order 1Experimental Treatment2 Interventions
First the typical nipple and then challenging nipple

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,863 Previous Clinical Trials
6,441,501 Total Patients Enrolled
Amanda Crandall, PhDPrincipal InvestigatorUniversity of Michigan
Julie Lumeng, MDPrincipal InvestigatorUniversity of Michigan
6 Previous Clinical Trials
1,697 Total Patients Enrolled
~20 spots leftby Apr 2027
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