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

NCT ID: NCT04674033

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-18

Study Completion Date

2020-07-01

Brief Summary

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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

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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)

Conditions

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Obesity

Keywords

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Pregnancy Nutrition Obesity Mother Infant Cognitive development Growth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Consumer

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

No interventions assigned to this group

Non-Consumer

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Michael I. Goran

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael I Goran

Role: PRINCIPAL_INVESTIGATOR

University of Southern California; Children's Hospital Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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CHLA-18-00455

Identifier Type: -

Identifier Source: org_study_id