Status:
COMPLETED
The Sweet PEA Study: Effects of Diet During Pregnancy on Infant Growth and Development.
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Children's Hospital Los Angeles
Conditions:
Obesity
Eligibility:
FEMALE
18-40 years
Brief Summary
The purpose of the Sweet PEA Study is to determine whether diet during pregnancy has an effect on infant's growth, body composition, and brain development.
Detailed Description
Rationale: Non-nutritive sweetener (NNS) consumption during pregnancy is prevalent, but effects on maternal and infant health are not well known. Intervention: None Objectives: To determine whether NN...
Eligibility Criteria
Inclusion
- Mothers:
- Pregnant women prior to 28 weeks gestation
- Report the least NNS consumption of pre-screened participants (0 servings per week - representing the control group) and most NNS consumption of pre-screened participants (≥ 5 servings per week - representing the experimental group).
- 18-40 years of age
- Singleton pregnancy
- Be able/willing to understand the procedures of the study
- Be able to read English at a 5th grade level (materials also available in Spanish, if required)
- Infants:
- Infant's mother must be enrolled in the study and provide infant assent to participate
Exclusion
- Mothers:
- Physician diagnosis of a major medical illness
- Pre-existing diabetes (type 1 or type 2), or GDM in a previous pregnancy
- Physical, mental, or cognitive issues preventing participation
- Medications that may affect body weight, body composition, insulin resistance, or lipid profiles
- Tobacco or drug use (any current use or quitting during pregnancy)
- Alcohol consumption during pregnancy (\>1 drink per week)
- Infants:
- Presumed or known congenital birth defects
Key Trial Info
Start Date :
January 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04674033
Start Date
January 18 2019
End Date
July 1 2020
Last Update
December 6 2024
Active Locations (1)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027