Status:
WITHDRAWN
Determine if Human Infant Weight Gain Can be Modulated to Prevent Obesity
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborating Sponsors:
Federal University of São Paulo
Conditions:
Obesity, Infant
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The global obesity epidemic has extended to low and middle income countries (LMICs) in which in a dramatic nutritional transition has shifted from maternal/child undernutrition to overnutrition. Withi...
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 studies will be performed at the Ana ...
Eligibility Criteria
Inclusion
- Mother infant dyads are eligible for the study, with equal proportion of male and female infant in each study group.
- Breast Milk Calibration Study: Study women (pre-pregnant BMI\>30) who are providing exclusive human milk via pumping and bottle (50%/50% male/female) will be recruited at the 7-9 week postpartum visit.
- Formula Milk Calibration Study: Study women (pre-pregnant BMI\>30) who are providing formula via bottle (50%/50% male/female) will be recruited at the 7-9 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 :
December 20 2026
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04526860
Start Date
December 20 2026
End Date
December 1 2028
Last Update
November 21 2025
Active Locations (1)
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1
Breastfeeding Center Ana Abrao, Federal of São Paulo University, Brazil
São Paulo, São Paulo, Brazil, 04025-002