NOT_YET_RECRUITING
Pre-Pregnancy Weight Loss and Baby Behavior Study
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.
Conditions:
🦠 Obesity; Familial 🦠 Pregnancy Related 🦠 Infant Behavior
🗓️ Study Start (Actual) June 2024
🗓️ Primary Completion (Estimated) April 2027
✅ Study Completion (Estimated) April 2027
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

  • To be eligible to participate in this study...
  • Mother
  • -Current or previous participation in the PLAN study resulting in a live birth.
  • Child
  • * Mother participated in PLAN study during child's gestation
  • * Infant birth weight (From PLAN study records) appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set (Oken et al, BMC Pediatrics 2003).
  • * Infant is 3.0 to 6.0 months old at Consent.
  • * Biological mother is legal guardian by maternal report.
  • * Biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time).
  • * Infant typically consumes at least 2 ounces in one feeding from an artificial nipple and bottle at least once per week by maternal report.
  • * Stated willingness by mother to comply with all study procedures and availability for the duration of the study.
Ages Eligible for Study: 3 Months to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 April 2024
  • First Submitted that Met QC Criteria 5 April 2024
  • First Posted 11 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 June 2024
  • Last Update Posted 7 June 2024
  • Last Verified June 2024