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

NCT04674033 | Completed

• 1 other identifier: CHLA-18-00455
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Pregnancy; Nutrition; Obesity; Mother; Infant; Cognitive development; Growth

Outcome Measures

Primary Outcomes (21)

• Infant length at 1 Month

  Infant length (cm) will be measured using an infant measure mat.

  1 month

• Infant length at 6 Months

  Infant length (cm) will be measured using an infant measure mat.

  6 months

• Infant length at 12 Months

  Infant length (cm) will be measured using an infant measure mat.

  12 months

• Infant weight at 1 Month

  Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).

  1 month

• Infant weight at 6 Months

  Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).

  6 months

• Infant weight at 12 Months

  Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).

  12 months

• Infant weight z-scores at 1 Month

  Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.

  1 month

• Infant weight z-scores at 6 Months

  Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.

  6 months

• Infant weight z-scores at 12 Months

  Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.

  12 months

• Infant body fat measured using an EchoMRI body composition analyzer at 1 month

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

  1 month

• Infant body fat measured using an EchoMRI body composition analyzer at 6 months

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

  6 months

• Infant body fat measured using an EchoMRI body composition analyzer at 12 months

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

  12 months

• Infant lean mass measured using an EchoMRI body composition analyzer at 1 month

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

  1 month

• Infant lean mass measured using an EchoMRI body composition analyzer at 6 months

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

  6 months

• Infant lean mass measured using an EchoMRI body composition analyzer at 12 months

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

  12 months

• Infant total body water measured using an EchoMRI body composition analyzer at 1 month

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

  1 month

• Infant total body water measured using an EchoMRI body composition analyzer at 6 months

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

  6 month

• Infant total body water measured using an EchoMRI body composition analyzer at 12 months

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

  12 month

• Infant free body water measured using an EchoMRI body composition analyzer at 1 month

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

  1 month

• Infant free body water measured using an EchoMRI body composition analyzer at 6 months

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

  6 months

• Infant free body water measured using an EchoMRI body composition analyzer at 12 months

  An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

  12 months

Secondary Outcomes (82)

• Maternal height at 1 month

  1 month

• Maternal height at 6 months

  6 months

• Maternal height at 12 months

  12 months

• Maternal weight at 1 month

  1 month

• Maternal weight at 6 months

  6 months

Study Arms (2)

Consumer

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

Non-Consumer

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women (18 - 40 years) who do and do not report non-nutritive sweetener consumption, and their infants (\<1-12 months) from Los Angeles, CA.

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Children's Hospital Los Angeles: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Breast milk; Stool

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael I Goran

  University of Southern California; Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 17, 2020
• Study Start: January 18, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (1)