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Completed

NCT Number: NCT06358729

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.

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Key information

Age range

3 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Typical Nipple

Behavioral

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

Challenging Nipple

Behavioral

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

Primary outcomes

  1. Suck effect

    Time frame: Up to 6 weeks

    Sucking will be measured with the NFANT® Feeding Solution

Secondary outcomes

  1. Sucking pressure

    Time frame: Up to 6 weeks

    Sucking will be measured with the NFANT® Feeding Solution

  2. Sucking frequency

    Time frame: Up to 6 weeks

    Sucking will be measured with the NFANT® Feeding Solution

  3. Milk/Formula intake

    Time frame: Up to 6 weeks

  4. Milk/Formula consumption rate

    Time frame: Up to 6 weeks

  5. Number of Feedings Over 24 Hours

    Time frame: Up to 6 weeks

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

    Time frame: Up to 6 weeks

  7. Total Night Wake-ups within 24 hours of intervention

    Time frame: Up to 6 weeks

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

The Impact of Pre-Pregnancy Weight Loss on Infant Sucking Behavior in Response to a Challenging Nipple

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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