Pre-Pregnancy Weight Loss and Baby Behavior Study

University of Michigan

Status: Invitation-only

Conditions: Obesity; Familial; Pregnancy Related; Infant Behavior

Treatments: Behavioral: Typical Nipple; Behavioral: Challenging Nipple

Study type: Interventional

Funder types: Other

Identifiers

NCT06358729

HUM00239775

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 3+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Nipple order 1

Experimental group

Description:

First the typical nipple and then challenging nipple

Treatment:

Behavioral: Challenging Nipple

Behavioral: Typical Nipple

Nipple order 2

Experimental group

Description:

First the challenging nipple and then the typical nipple

Treatment:

Behavioral: Challenging Nipple

Behavioral: Typical Nipple