Status:
ACTIVE_NOT_RECRUITING
Maternal Obesity, Breast Milk Composition, and Infant Growth
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
HealthPartners Institute
Conditions:
Obesity
Pregnancy
Eligibility:
All Genders
Up to 45 years
Brief Summary
Today the majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity, a...
Detailed Description
General Study Design A prospective observational pregnancy cohort of 600 women who exclusively breastfeed their infants to at least 1 month post-partum, will be recruited in the second trimester of pr...
Eligibility Criteria
Inclusion
- Pregnant females
- 21 to 45 years of age at the time of delivery
- Pre-gravid BMI between 18.5 to 40 kg/m2
- Healthy pregnancy defined as \<3 days in hospital following delivery
- Report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3-months
- If parity \>1, report that they successfully breast fed a previous pregnancy for at least 3 months
- Singleton gestation
- Term pregnancy (gestational age \>37 but \<42 weeks)
- Infant birth weight \>2,500 grams but \<4,500 grams.
Exclusion
- Alcohol consumption \>1 drink per week during pregnancy/lactation
- Tobacco consumption during pregnancy/lactation
- History/current Type I or II diabetes
- Inability to speak/understand English
- Known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding/growth
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
2050 Patients enrolled
Trial Details
Trial ID
NCT03301753
Start Date
July 1 2014
End Date
December 31 2026
Last Update
August 24 2025
Active Locations (2)
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1
University of Minnesota School of Public Health
Minneapolis, Minnesota, United States, 55454
2
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104