The Sweet PEA Study: Effects of Diet During Pregnancy on Infant Growth and Development.

University of Southern California

Status: Completed

Conditions: Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT04674033

CHLA-18-00455

Details and patient eligibility

About

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.

Full 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 NNS consumption during pregnancy is associated with increased infant body fat, as well as differences in infant growth, brain structure/function, gut microbiota, and gestational diabetes. Study population: Women prior to 28 weeks' gestation, determined to have either low/no NNS consumption (control) or high NNS consumption (experimental), based on a pre-screening survey. Methodology: Identify two groups (low/high consumers) in early pregnancy, collect data during pregnancy remotely (telephone, internet, medical records) to determine diet and any link to pregnancy complications, have in-person visits with mothers/infants at 1, 6, and 12 months of age, collecting: body composition data (by EchoMRI), brain structure/connectivity (MRI), stool samples. Outcomes: Primary outcome is infant adiposity at 1, 6, and 12 months. Additional measures include infant growth, feeding behaviors, brain structure/ connectivity, gut microbiota, and maternal metabolic outcomes during routine gestational testing (fasting glucose, insulin, triglycerides, gestational diabetes diagnosis) Follow-up: This will operate as a small pilot study, and a larger study with more participants, a wider spectrum of NNS exposure, and longer follow up (into childhood and beyond) may follow. Statistics: Multivariate linear mixed effects examining maternal NNS intake and outcomes across time (repeated measures)

Enrollment: 93 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

93 participants in 2 patient groups

Consumer

Description:

Participants who self-report regular consumption of non-nutritive sweeteners (\>/=5 servings/week) based on a pre-screening dietary survey.

Non-Consumer

Description:

Participants who self-report no consumption of non-nutritive sweeteners (0 servings/week) based on a pre-screening dietary survey.