Pre-Pregnancy Weight Loss and Baby Behavior Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-13

Study Completion Date

2027-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity; Familial Pregnancy Related Infant Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Order of nipple size use is counter-balanced, caregivers are blind to nipple size and amount of milk in the bottle (i.e., the bottle is covered) to minimize their influence over the infant's consumption. Research assistants will not be blind to nipple size as they will need to set the bottles ups for the mothers.

Study Groups

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Nipple order 1

First the typical nipple and then challenging nipple

Group Type EXPERIMENTAL

Typical Nipple

Intervention Type BEHAVIORAL

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

Challenging Nipple

Intervention Type BEHAVIORAL

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

Nipple order 2

First the challenging nipple and then the typical nipple

Group Type EXPERIMENTAL

Typical Nipple

Intervention Type BEHAVIORAL

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

Challenging Nipple

Intervention Type BEHAVIORAL

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

Interventions

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Typical Nipple

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

Intervention Type BEHAVIORAL

Challenging Nipple

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes