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 range

18 Years – 40 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 40 Years

Sex

FEMALE

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