Status:

COMPLETED

Prevention of Obesity in Infants of Overweight and Obese Women

Lead Sponsor:

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Conditions:

Infant Obesity

Eligibility:

FEMALE

16-50 years

Phase:

NA

Brief Summary

Maternal and childhood obesity have dramatically increased and continue to present a significant health problem. Studies show that offspring of overweight (body mass index, BMI \>25-29.9) and obese (B...

Detailed Description

This is a clinical intervention study to calibrate infant milk or formula intake and modulate infant weight gain to prevent the development of infant obesity. The investigators will study only OW/OB w...

Eligibility Criteria

Inclusion

  • Breast Milk Calibration Study: Study women (pre-pregnant BMI 25-29.9 and ≥30) who are providing exclusive human milk via pumping and bottle (50%/50% male/female) will be recruited at the 3-6 week postpartum visit.
  • Formula Milk Calibration Study: Study women (pre-pregnant BMI 25-29.9 and ≥30) who are providing formula via bottle (50%/50% male/female) will be recruited at the 3-6 week postpartum visit.

Exclusion

  • Breast Milk Calibration Study: breast implants, prior breast surgery, flat/ inverted nipples, tongue-tie or low birth weight infants.
  • Formula Milk Calibration Study: low birth weight infants.

Key Trial Info

Start Date :

January 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 30 2024

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04782063

Start Date

January 1 2022

End Date

May 30 2024

Last Update

November 20 2025

Active Locations (1)

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Penn State College of Medicine

Hershey, Pennsylvania, United States, 17033