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Behavioral Intervention

Nipple order 1 for Pregnancy

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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Suck effect
Secondary outcome measures
Milk/Formula consumption rate
Milk/Formula intake
Number of Feedings Over 24 Hours
+4 more

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
1,799 Previous Clinical Trials
6,378,608 Total Patients Enrolled
Amanda Crandall, PhDPrincipal InvestigatorUniversity of Michigan
Julie Lumeng, MDPrincipal InvestigatorUniversity of Michigan
6 Previous Clinical Trials
1,697 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"As per the details on clinicaltrials.gov, this specific trial is currently not in the recruitment phase. The initial posting date for this study was 4/1/2024 with the most recent update noted as 4/5/2024. While participant enrollment for this particular research endeavor is closed at present, it's worth highlighting that there are a total of 366 alternative trials actively seeking participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pre-Pregnancy Weight Loss and Baby Behavior Study
Amanda Kinney Crandall 2024. "Pre-Pregnancy Weight Loss and Baby Behavior Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06358729.
~20 spots leftby Apr 2027
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