Pre-Pregnancy Weight Loss and Baby Behavior Study

N/AEnrolling By InvitationNCT06358729

University of Michigan30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Obesity; Familial Pregnancy Related Infant Behavior

Interventions

Typical NippleBEHAVIORAL

Infants are fed their typical milk/formula by their caregiver when hungry, one feeding with their typical nipple.

Challenging NippleBEHAVIORAL

Infants are fed with a smaller sized nipple (i.e. with a smaller aperture, slowing the rate of milk delivery).

Eligibility

Sex: ALLMin age: 3 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Suck effect

Sucking will be measured with the NFANT® Feeding Solution

Time frame: Up to 6 weeks

Secondary Outcomes

Sucking pressure

Sucking will be measured with the NFANT® Feeding Solution

Time frame: Up to 6 weeks

Sucking frequency

Sucking will be measured with the NFANT® Feeding Solution

Time frame: Up to 6 weeks

Milk/Formula intake

Time frame: Up to 6 weeks

Milk/Formula consumption rate

Time frame: Up to 6 weeks

Number of Feedings Over 24 Hours

Time frame: Up to 6 weeks

Total Hours of Sleep per 24 Hours within 24 hours of intervention

Time frame: Up to 6 weeks

Total Night Wake-ups within 24 hours of intervention

Time frame: Up to 6 weeks

Data from ClinicalTrials.gov

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