Clinical trial NCT06358729: Pre-Pregnancy Weight Loss and Baby Behavior Study
Official title: The Impact of Pre-Pregnancy Weight Loss on Infant Sucking Behavior in Response to a Challenging Nipple
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity; Familial
Pregnancy Related
Infant Behavior
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: The researchers will recruit babies from the original cohort in the PLAN study (NCT03244722), regardless of which arms they participated in. However, the researchers will test the study arms from the original PLAN study for effects on the study's dependent variables. Their between-subjects arms included Pre-pregnancy obesity with intensive weight loss intervention, pre-pregnancy obesity with standard of care intervention, and pre-pregnancy healthy weight with no intervention. So, although the researchers are not assigning babies to any arms, their original assignment will still be assessed the study analysis.

Eligibility criteria: 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.

Primary outcomes:
measure: Suck effect
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Sucking pressure
timeFrame: Up to 6 weeks
measure: Sucking frequency
timeFrame: Up to 6 weeks
measure: Milk/Formula intake
timeFrame: Up to 6 weeks
measure: Milk/Formula consumption rate
timeFrame: Up to 6 weeks
measure: Number of Feedings Over 24 Hours
timeFrame: Up to 6 weeks
measure: Total Hours of Sleep per 24 Hours within 24 hours of intervention
timeFrame: Up to 6 weeks
measure: Total Night Wake-ups within 24 hours of intervention
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amanda Crandall, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Julie Lumeng, MD
role: PRINCIPAL_INVESTIGATOR
References: