CompletedNot Applicable

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

United States93 participantsStarted 2019-01-18

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Infant length at 1 Month

Timeframe: 1 month

Infant length at 6 Months

Timeframe: 6 months

Infant length at 12 Months

Timeframe: 12 months

Infant weight at 1 Month

Timeframe: 1 month

Infant weight at 6 Months

Timeframe: 6 months

Infant weight at 12 Months

Timeframe: 12 months

Infant weight z-scores at 1 Month

Timeframe: 1 month

Infant weight z-scores at 6 Months

Timeframe: 6 months

Infant weight z-scores at 12 Months

Timeframe: 12 months

Trial details

NCT IDNCT04674033

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-07-01

View on ClinicalTrials.gov More Obesity trials

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Infant length at 1 Month

Timeframe: 1 month

Infant length at 6 Months

Timeframe: 6 months

Infant length at 12 Months

Timeframe: 12 months

Infant weight at 1 Month

Timeframe: 1 month

Infant weight at 6 Months

Timeframe: 6 months

Infant weight at 12 Months

Timeframe: 12 months

Infant weight z-scores at 1 Month

Timeframe: 1 month

Infant weight z-scores at 6 Months

Timeframe: 6 months

Infant weight z-scores at 12 Months

Timeframe: 12 months