Clinical trial NCT04674033: The Sweet PEA Study: Effects of Diet During Pregnancy on Infant Growth and Development.
Official title: The Sweet PEA Study: a Pilot Study of the Impact of Non-nutritive Sweetener Consumption During Pregnancy on Maternal and Infant Metabolic Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Pregnancy
Nutrition
Obesity
Mother
Infant
Cognitive development
Growth
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
First posted: 2020-12-17
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Infant length at 1 Month
timeFrame: 1 month
measure: Infant length at 6 Months
timeFrame: 6 months
measure: Infant length at 12 Months
timeFrame: 12 months
measure: Infant weight at 1 Month
timeFrame: 1 month
measure: Infant weight at 6 Months
timeFrame: 6 months
measure: Infant weight at 12 Months
timeFrame: 12 months
measure: Infant weight z-scores at 1 Month
timeFrame: 1 month
measure: Infant weight z-scores at 6 Months
timeFrame: 6 months
measure: Infant weight z-scores at 12 Months
timeFrame: 12 months
measure: Infant body fat measured using an EchoMRI body composition analyzer at 1 month
timeFrame: 1 month
measure: Infant body fat measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant body fat measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 1 month
timeFrame: 1 month
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
measure: Infant total body water measured using an EchoMRI body composition analyzer at 1 month
timeFrame: 1 month
measure: Infant total body water measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 month
measure: Infant total body water measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 month
measure: Infant free body water measured using an EchoMRI body composition analyzer at 1 month
timeFrame: 1 month
measure: Infant free body water measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant free body water measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Maternal height at 1 month
timeFrame: 1 month
measure: Maternal height at 6 months
timeFrame: 6 months
measure: Maternal height at 12 months
timeFrame: 12 months
measure: Maternal weight at 1 month
timeFrame: 1 month
measure: Maternal weight at 6 months
timeFrame: 6 months
measure: Maternal weight at 12 months
timeFrame: 12 months
measure: Maternal BMI at 1 Month
timeFrame: 1 month
measure: Maternal BMI at 6 Months
timeFrame: 6 months
measure: Maternal BMI at 12 Months
timeFrame: 12 months
measure: Maternal blood glucose at Pregnancy visit 2
timeFrame: ~35 weeks' gestation
measure: Maternal pregravid BMI
timeFrame: 24-28 weeks' gestation
measure: Maternal blood pressure at 1 month
timeFrame: 1 month
measure: Maternal blood pressure at 6 months
timeFrame: 6 months
measure: Maternal blood pressure at 12 months
timeFrame: 12 months
measure: Maternal resting heart rate at 1 month
timeFrame: 1 month
measure: Maternal resting heart rate at 6 months
timeFrame: 6 months
measure: Maternal resting heart rate at 12 months
timeFrame: 12 months
measure: Maternal diet at Pregnancy visit 1
timeFrame: 24-28 weeks' gestation
measure: Maternal diet at Pregnancy visit 2
timeFrame: ~35 weeks' gestation
measure: Maternal diet at 1 month
timeFrame: 1 month
measure: Maternal diet at 6 months
timeFrame: 6 months
measure: Maternal diet at 12 months
timeFrame: 12 months
measure: Infant diet at 1 month
timeFrame: 1 month
measure: Infant diet at 6 months
timeFrame: 6 months
measure: Infant diet at 12 months
timeFrame: 12 months
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 1 month
timeFrame: 1 month
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 6 months
timeFrame: 6 months
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 12 months
timeFrame: 12 months
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 1 month
timeFrame: 1 month
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months
timeFrame: 6 months
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months
timeFrame: 12 months
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 1 month
timeFrame: 1 month
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 6 months
timeFrame: 6 months
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 12 months
timeFrame: 12 months
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 1 month
timeFrame: 1 month
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months
timeFrame: 6 months
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 12 months
timeFrame: 12 months
measure: Breast milk composition at 1 month
timeFrame: 1 month
measure: Breast milk composition at 6 months
timeFrame: 6 months
measure: Breast milk composition at 12 months
timeFrame: 12 months
measure: Infant Magnetic Resonance Imaging (MRI) brain scan at 1 month
timeFrame: 1 month
measure: Infant Magnetic Resonance Imaging (MRI) brain scan at 6 months
timeFrame: 6 months
measure: Infant gut microbiome at 1 Month
timeFrame: 1 month
measure: Infant gut microbiome at 6 Months
timeFrame: 6 months
measure: Infant gut microbiome at 12 Months
timeFrame: 12 months
measure: Maternal gut microbiome at 1 month
timeFrame: 1 month
measure: Maternal gut microbiome at 6 months
timeFrame: 6 months
measure: Maternal gut microbiome at 12 months
timeFrame: 12 months
measure: Infant Diet and Behavior Questionnaire at 1 month
timeFrame: 1 month
measure: Infant Diet and Behavior Questionnaire at 6 months
timeFrame: 6 months
measure: Infant Diet and Behavior Questionnaire at 12 months
timeFrame: 12 months
measure: CDC Infant Feeding Practices Survey II at 1 month
timeFrame: 1 month
measure: CDC Infant Feeding Practices Survey II at 6 months
timeFrame: 6 months
measure: CDC Infant Feeding Practices Survey II at 12 months
timeFrame: 12 months
measure: Maternal Beverage Recall at Pregnancy visit 1
timeFrame: 24-28 weeks' gestation
measure: Maternal Beverage Recall at Pregnancy visit 2
timeFrame: ~35 weeks' gestation
measure: Maternal Beverage Recall at 1 month
timeFrame: 1 month
measure: Maternal Beverage Recall at 6 months
timeFrame: 6 months
measure: Maternal Beverage Recall at 12 months
timeFrame: 12 months
measure: Infant Beverage Recall at 1 month
timeFrame: 1 month
measure: Infant Beverage Recall at 6 months
timeFrame: 6 months
measure: Infant Beverage Recall at 12 months
timeFrame: 12 months
measure: Perinatal Anxiety Screening Scale (PASS) at Pregnancy visit 1
timeFrame: 24-28 weeks' gestation
measure: Perinatal Anxiety Screening Scale (PASS) at Pregnancy visit 2
timeFrame: ~35 weeks' gestation
measure: Perinatal Anxiety Screening Scale (PASS) at 1 month
timeFrame: 1 month
measure: Perinatal Anxiety Screening Scale (PASS) at 6 months
timeFrame: 6 months
measure: Perinatal Anxiety Screening Scale (PASS) at 12 months
timeFrame: 12 months
measure: Edinburgh Postnatal Depression Scale (EPDS) at Pregnancy visit 1
timeFrame: 24-28 weeks' gestation
measure: Edinburgh Postnatal Depression Scale (EPDS) at Pregnancy visit 2
timeFrame: ~35 weeks' gestation
measure: Edinburgh Postnatal Depression Scale (EPDS) at 1 month
timeFrame: 1 month
measure: Edinburgh Postnatal Depression Scale (EPDS) at 6 months
timeFrame: 6 months
measure: Edinburgh Postnatal Depression Scale (EPDS) at 12 months
timeFrame: 12 months
measure: Pregnancy Physical Activity Questionnaire at Pregnancy visit 1
timeFrame: 24-28 weeks' gestation
measure: Pregnancy Physical Activity Questionnaire at Pregnancy visit 2
timeFrame: ~35 weeks' gestation
measure: Pregnancy Physical Activity Questionnaire at 1 month
timeFrame: 1 month
measure: Pregnancy Physical Activity Questionnaire at 6 months
timeFrame: 6 months
measure: Pregnancy Physical Activity Questionnaire at 12 months
timeFrame: 12 months
measure: Pittsburgh Sleep Quality Index (PSQI) at Pregnancy visit 1
timeFrame: 24-28 weeks' gestation
measure: Pittsburgh Sleep Quality Index (PSQI) at Pregnancy visit 2
timeFrame: ~35 weeks' gestation
measure: Pittsburgh Sleep Quality Index (PSQI) at 1 month
timeFrame: 1 month
measure: Pittsburgh Sleep Quality Index (PSQI) at 6 months
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index (PSQI) at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: University of Southern California; Children's Hospital Los Angeles
name: Michael I Goran
role: PRINCIPAL_INVESTIGATOR
References: