The Sweet PEA Study: a Pilot Study of the Impact of Non-nutritive Sweetener Consumption During Pregnancy on Maternal and Infant Metabolic Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Southern California
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Infant length at 1 Month
- Status
- Completed
- Last Updated
- last year
Overview
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)
Investigators
Michael I. Goran
Principal Investigator
University of Southern California
Eligibility Criteria
Inclusion Criteria
- •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)
- •Infant's mother must be enrolled in the study and provide infant assent to participate
Exclusion Criteria
- •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)
- •Presumed or known congenital birth defects
Outcomes
Primary Outcomes
Infant length at 1 Month
Time Frame: 1 month
Infant length (cm) will be measured using an infant measure mat.
Infant length at 6 Months
Time Frame: 6 months
Infant length (cm) will be measured using an infant measure mat.
Infant weight at 1 Month
Time Frame: 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).
Infant weight at 6 Months
Time Frame: 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).
Infant lean mass measured using an EchoMRI body composition analyzer at 1 month
Time Frame: 1 month
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
Time Frame: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 6 months
Time Frame: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant length at 12 Months
Time Frame: 12 months
Infant length (cm) will be measured using an infant measure mat.
Infant weight at 12 Months
Time Frame: 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).
Infant weight z-scores at 1 Month
Time Frame: 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.
Infant weight z-scores at 6 Months
Time Frame: 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.
Infant weight z-scores at 12 Months
Time Frame: 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.
Infant body fat measured using an EchoMRI body composition analyzer at 1 month
Time Frame: 1 month
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 1 month
Time Frame: 1 month
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant body fat measured using an EchoMRI body composition analyzer at 6 months
Time Frame: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 6 months
Time Frame: 6 month
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 12 months
Time Frame: 12 month
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 1 month
Time Frame: 1 month
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 12 months
Time Frame: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant body fat measured using an EchoMRI body composition analyzer at 12 months
Time Frame: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 12 months
Time Frame: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Secondary Outcomes
- Maternal BMI at 6 Months(6 months)
- Maternal blood pressure at 6 months(6 months)
- Maternal height at 12 months(12 months)
- Maternal blood pressure at 1 month(1 month)
- Maternal resting heart rate at 6 months(6 months)
- Maternal resting heart rate at 12 months(12 months)
- Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 12 months(12 months)
- Infant Magnetic Resonance Imaging (MRI) brain scan at 1 month(1 month)
- Infant Magnetic Resonance Imaging (MRI) brain scan at 6 months(6 months)
- Infant Diet and Behavior Questionnaire at 6 months(6 months)
- Infant Diet and Behavior Questionnaire at 12 months(12 months)
- Infant Beverage Recall at 12 months(12 months)
- Edinburgh Postnatal Depression Scale (EPDS) at 12 months(12 months)
- Pregnancy Physical Activity Questionnaire at 1 month(1 month)
- Pregnancy Physical Activity Questionnaire at 6 months(6 months)
- Pittsburgh Sleep Quality Index (PSQI) at 1 month(1 month)
- Maternal height at 1 month(1 month)
- Maternal height at 6 months(6 months)
- Maternal weight at 6 months(6 months)
- Maternal BMI at 1 Month(1 month)
- Maternal blood glucose at Pregnancy visit 2(~35 weeks' gestation)
- Maternal diet at Pregnancy visit 1(24-28 weeks' gestation)
- Infant diet at 6 months(6 months)
- Maternal weight at 12 months(12 months)
- Maternal pregravid BMI(24-28 weeks' gestation)
- Maternal diet at Pregnancy visit 2(~35 weeks' gestation)
- Maternal diet at 1 month(1 month)
- Maternal weight at 1 month(1 month)
- Maternal BMI at 12 Months(12 months)
- Maternal diet at 6 months(6 months)
- Maternal diet at 12 months(12 months)
- Infant diet at 1 month(1 month)
- Infant feeding score assessed by Infant Feeding Questionnaire at 12 months(12 months)
- Infant gut microbiome at 1 Month(1 month)
- Infant gut microbiome at 12 Months(12 months)
- Maternal gut microbiome at 12 months(12 months)
- CDC Infant Feeding Practices Survey II at 6 months(6 months)
- Maternal Beverage Recall at 12 months(12 months)
- Infant Beverage Recall at 6 months(6 months)
- Perinatal Anxiety Screening Scale (PASS) at 1 month(1 month)
- Edinburgh Postnatal Depression Scale (EPDS) at 1 month(1 month)
- Maternal blood pressure at 12 months(12 months)
- Maternal resting heart rate at 1 month(1 month)
- Infant diet at 12 months(12 months)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at 1 month(1 month)
- Infant behavior score assessed by Infant Behavior Questionnaire at 12 months(12 months)
- Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 1 month(1 month)
- Breast milk composition at 1 month(1 month)
- Infant feeding score assessed by Infant Feeding Questionnaire at 1 month(1 month)
- Infant feeding score assessed by Infant Feeding Questionnaire at 6 months(6 months)
- Breast milk composition at 12 months(12 months)
- Maternal gut microbiome at 1 month(1 month)
- Maternal gut microbiome at 6 months(6 months)
- CDC Infant Feeding Practices Survey II at 1 month(1 month)
- Maternal Beverage Recall at Pregnancy visit 1(24-28 weeks' gestation)
- Maternal Beverage Recall at 1 month(1 month)
- Infant Beverage Recall at 1 month(1 month)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months(6 months)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months(12 months)
- Infant behavior score assessed by Infant Behavior Questionnaire at 1 month(1 month)
- Infant behavior score assessed by Infant Behavior Questionnaire at 6 months(6 months)
- Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months(6 months)
- Infant gut microbiome at 6 Months(6 months)
- Infant Diet and Behavior Questionnaire at 1 month(1 month)
- Maternal Beverage Recall at Pregnancy visit 2(~35 weeks' gestation)
- Maternal Beverage Recall at 6 months(6 months)
- Perinatal Anxiety Screening Scale (PASS) at Pregnancy visit 1(24-28 weeks' gestation)
- Breast milk composition at 6 months(6 months)
- CDC Infant Feeding Practices Survey II at 12 months(12 months)
- Perinatal Anxiety Screening Scale (PASS) at Pregnancy visit 2(~35 weeks' gestation)
- Perinatal Anxiety Screening Scale (PASS) at 6 months(6 months)
- Perinatal Anxiety Screening Scale (PASS) at 12 months(12 months)
- Edinburgh Postnatal Depression Scale (EPDS) at Pregnancy visit 2(~35 weeks' gestation)
- Edinburgh Postnatal Depression Scale (EPDS) at Pregnancy visit 1(24-28 weeks' gestation)
- Pregnancy Physical Activity Questionnaire at 12 months(12 months)
- Pittsburgh Sleep Quality Index (PSQI) at Pregnancy visit 1(24-28 weeks' gestation)
- Edinburgh Postnatal Depression Scale (EPDS) at 6 months(6 months)
- Pittsburgh Sleep Quality Index (PSQI) at 6 months(6 months)
- Pittsburgh Sleep Quality Index (PSQI) at 12 months(12 months)
- Pregnancy Physical Activity Questionnaire at Pregnancy visit 1(24-28 weeks' gestation)
- Pregnancy Physical Activity Questionnaire at Pregnancy visit 2(~35 weeks' gestation)
- Pittsburgh Sleep Quality Index (PSQI) at Pregnancy visit 2(~35 weeks' gestation)