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.
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)
Study Type
OBSERVATIONAL
Enrollment
93
Children's Hospital Los Angeles
Los Angeles, California, United States
Infant length at 1 Month
Infant length (cm) will be measured using an infant measure mat.
Time frame: 1 month
Infant length at 6 Months
Infant length (cm) will be measured using an infant measure mat.
Time frame: 6 months
Infant length at 12 Months
Infant length (cm) will be measured using an infant measure mat.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 1 month
Infant weight z-scores at 6 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Maternal height at 1 month
Height (cm) will be measured using a stadiometer.
Time frame: 1 month
Maternal height at 6 months
Height (cm) will be measured using a stadiometer.
Time frame: 6 months
Maternal height at 12 months
Height (cm) will be measured using a stadiometer.
Time frame: 12 months
Maternal weight at 1 month
Weight (kg) will be measured using a portable digital scale.
Time frame: 1 month
Maternal weight at 6 months
Weight (kg) will be measured using a portable digital scale.
Time frame: 6 months
Maternal weight at 12 months
Weight (kg) will be measured using a portable digital scale.
Time frame: 12 months
Maternal BMI at 1 Month
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.
Time frame: 1 month
Maternal BMI at 6 Months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.
Time frame: 6 months
Maternal BMI at 12 Months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.
Time frame: 12 months
Maternal blood glucose at Pregnancy visit 2
Mothers will self-report their most recent blood glucose levels.
Time frame: ~35 weeks' gestation
Maternal pregravid BMI
Maternal BMI prior to pregnancy will be derived from pregravid BMI (recall during pregnancy) using the equation (weight in kg)/(height in m)\^2.
Time frame: 24-28 weeks' gestation
Maternal blood pressure at 1 month
Sitting blood pressure will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Time frame: 1 month
Maternal blood pressure at 6 months
Sitting blood pressure will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Time frame: 6 months
Maternal blood pressure at 12 months
Sitting blood pressure will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Time frame: 12 months
Maternal resting heart rate at 1 month
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Time frame: 1 month
Maternal resting heart rate at 6 months
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Time frame: 6 months
Maternal resting heart rate at 12 months
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Time frame: 12 months
Maternal diet at Pregnancy visit 1
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR).
Time frame: 24-28 weeks' gestation
Maternal diet at Pregnancy visit 2
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR).
Time frame: ~35 weeks' gestation
Maternal diet at 1 month
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR).
Time frame: 1 month
Maternal diet at 6 months
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR).
Time frame: 6 months
Maternal diet at 12 months
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR).
Time frame: 12 months
Infant diet at 1 month
24-hour diet recalls will be conducted for one week day and one weekend day. Mothers will be interviewed to report on their infant's food intake. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR).
Time frame: 1 month
Infant diet at 6 months
24-hour diet recalls will be conducted for one week day and one weekend day. Mothers will be interviewed to report on their infant's food intake. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR).
Time frame: 6 months
Infant diet at 12 months
24-hour diet recalls will be conducted for one week day and one weekend day. Mothers will be interviewed to report on their infant's food intake. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR).
Time frame: 12 months
Infant feeding score assessed by Infant Feeding Questionnaire at 1 month
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Time frame: 1 month
Infant feeding score assessed by Infant Feeding Questionnaire at 6 months
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Time frame: 6 months
Infant feeding score assessed by Infant Feeding Questionnaire at 12 months
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Time frame: 12 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 1 month
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Time frame: 1 month
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Time frame: 6 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Time frame: 12 months
Infant behavior score assessed by Infant Behavior Questionnaire at 1 month
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Time frame: 1 month
Infant behavior score assessed by Infant Behavior Questionnaire at 6 months
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Time frame: 6 months
Infant behavior score assessed by Infant Behavior Questionnaire at 12 months
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Time frame: 12 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 1 month
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Time frame: 1 month
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Time frame: 6 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 12 months
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Time frame: 12 months
Breast milk composition at 1 month
Breast milk will be collected from mothers at least 11⁄2 hours since the last feeding and while the mother has fasted at least 1 hour. Samples will be analyzed for glucose, fructose, galactose, lactose and sucrose by mass spectrometry. Samples will be available for analysis of insulin, leptin, and energy content.
Time frame: 1 month
Breast milk composition at 6 months
Breast milk will be collected from mothers at least 11⁄2 hours since the last feeding and while the mother has fasted at least 1 hour. Samples will be analyzed for glucose, fructose, galactose, lactose and sucrose by mass spectrometry. Samples will be available for analysis of insulin, leptin, and energy content.
Time frame: 6 months
Breast milk composition at 12 months
Breast milk will be collected from mothers at least 11⁄2 hours since the last feeding and while the mother has fasted at least 1 hour. Samples will be analyzed for glucose, fructose, galactose, lactose and sucrose by mass spectrometry. Samples will be available for analysis of insulin, leptin, and energy content.
Time frame: 12 months
Infant Magnetic Resonance Imaging (MRI) brain scan at 1 month
Infant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.
Time frame: 1 month
Infant Magnetic Resonance Imaging (MRI) brain scan at 6 months
Infant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.
Time frame: 6 months
Infant gut microbiome at 1 Month
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Time frame: 1 month
Infant gut microbiome at 6 Months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Time frame: 6 months
Infant gut microbiome at 12 Months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Time frame: 12 months
Maternal gut microbiome at 1 month
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Time frame: 1 month
Maternal gut microbiome at 6 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Time frame: 6 months
Maternal gut microbiome at 12 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Time frame: 12 months
Infant Diet and Behavior Questionnaire at 1 month
Participants will report when they stopped breastfeeding/introduced formula or solid foods.
Time frame: 1 month
Infant Diet and Behavior Questionnaire at 6 months
Participants will report when they stopped breastfeeding/introduced formula or solid foods.
Time frame: 6 months
Infant Diet and Behavior Questionnaire at 12 months
Participants will report when they stopped breastfeeding/introduced formula or solid foods.
Time frame: 12 months
CDC Infant Feeding Practices Survey II at 1 month
Participants will answer questions about their and their infant's diet.
Time frame: 1 month
CDC Infant Feeding Practices Survey II at 6 months
Participants will answer questions about their and their infant's diet.
Time frame: 6 months
CDC Infant Feeding Practices Survey II at 12 months
Participants will answer questions about their and their infant's diet.
Time frame: 12 months
Maternal Beverage Recall at Pregnancy visit 1
Participants will report the beverages they have consumed over the past week. This data will be used to assess nutritional intake based on beverages.
Time frame: 24-28 weeks' gestation
Maternal Beverage Recall at Pregnancy visit 2
Participants will report the beverages they have consumed over the past week. This data will be used to assess nutritional intake based on beverages.
Time frame: ~35 weeks' gestation
Maternal Beverage Recall at 1 month
Participants will report the beverages they have consumed over the past week. This data will be used to assess nutritional intake based on beverages.
Time frame: 1 month
Maternal Beverage Recall at 6 months
Participants will report the beverages they have consumed over the past week. This data will be used to assess nutritional intake based on beverages.
Time frame: 6 months
Maternal Beverage Recall at 12 months
Participants will report the beverages they have consumed over the past week. This data will be used to assess nutritional intake based on beverages.
Time frame: 12 months
Infant Beverage Recall at 1 month
Mother's will report the beverages their infant has consumed over the past week. This data will be used to assess nutritional intake based on beverages.
Time frame: 1 month
Infant Beverage Recall at 6 months
Mother's will report the beverages their infant has consumed over the past week. This data will be used to assess nutritional intake based on beverages.
Time frame: 6 months
Infant Beverage Recall at 12 months
Mother's will report the beverages their infant has consumed over the past week. This data will be used to assess nutritional intake based on beverages.
Time frame: 12 months
Perinatal Anxiety Screening Scale (PASS) at Pregnancy visit 1
Participants will answer questions regarding their stress levels during and after pregnancy. Minimum = 0; maximum = 93. Higher scores represent worse outcomes.
Time frame: 24-28 weeks' gestation
Perinatal Anxiety Screening Scale (PASS) at Pregnancy visit 2
Participants will answer questions regarding their stress levels during and after pregnancy. Minimum = 0; maximum = 93. Higher scores represent worse outcomes.
Time frame: ~35 weeks' gestation
Perinatal Anxiety Screening Scale (PASS) at 1 month
Participants will answer questions regarding their stress levels during and after pregnancy. Minimum = 0; maximum = 93. Higher scores represent worse outcomes.
Time frame: 1 month
Perinatal Anxiety Screening Scale (PASS) at 6 months
Participants will answer questions regarding their stress levels during and after pregnancy. Minimum = 0; maximum = 93. Higher scores represent worse outcomes.
Time frame: 6 months
Perinatal Anxiety Screening Scale (PASS) at 12 months
Participants will answer questions regarding their stress levels during and after pregnancy. Minimum = 0; maximum = 93. Higher scores represent worse outcomes.
Time frame: 12 months
Edinburgh Postnatal Depression Scale (EPDS) at Pregnancy visit 1
Participants will answer questions regarding their feelings and mood. Minimum = 0, maximum = 30. Higher scores represent worse outcomes.
Time frame: 24-28 weeks' gestation
Edinburgh Postnatal Depression Scale (EPDS) at Pregnancy visit 2
Participants will answer questions regarding their feelings and mood. Minimum = 0, maximum = 30. Higher scores represent worse outcomes.
Time frame: ~35 weeks' gestation
Edinburgh Postnatal Depression Scale (EPDS) at 1 month
Participants will answer questions regarding their feelings and mood. Minimum = 0, maximum = 30. Higher scores represent worse outcomes.
Time frame: 1 month
Edinburgh Postnatal Depression Scale (EPDS) at 6 months
Participants will answer questions regarding their feelings and mood. Minimum = 0, maximum = 30. Higher scores represent worse outcomes.
Time frame: 6 months
Edinburgh Postnatal Depression Scale (EPDS) at 12 months
Participants will answer questions regarding their feelings and mood. Minimum = 0, maximum = 30. Higher scores represent worse outcomes.
Time frame: 12 months
Pregnancy Physical Activity Questionnaire at Pregnancy visit 1
Participants will answer questions about their physical activity levels over the past week. Minimum: 0 (none), maximum: 5 (3 or more hours per day). Higher scores represent better outcomes.
Time frame: 24-28 weeks' gestation
Pregnancy Physical Activity Questionnaire at Pregnancy visit 2
Participants will answer questions about their physical activity levels over the past week. Minimum: 0 (none), maximum: 5 (3 or more hours per day). Higher scores represent better outcomes.
Time frame: ~35 weeks' gestation
Pregnancy Physical Activity Questionnaire at 1 month
Participants will answer questions about their physical activity levels over the past week. Minimum: 0 (none), maximum: 5 (3 or more hours per day). Higher scores represent better outcomes.
Time frame: 1 month
Pregnancy Physical Activity Questionnaire at 6 months
Participants will answer questions about their physical activity levels over the past week. Minimum: 0 (none), maximum: 5 (3 or more hours per day). Higher scores represent better outcomes.
Time frame: 6 months
Pregnancy Physical Activity Questionnaire at 12 months
Participants will answer questions about their physical activity levels over the past week. Minimum: 0 (none), maximum: 5 (3 or more hours per day). Higher scores represent better outcomes.
Time frame: 12 months
Pittsburgh Sleep Quality Index (PSQI) at Pregnancy visit 1
Participants will answer questions about their sleeping habits over the past week.
Time frame: 24-28 weeks' gestation
Pittsburgh Sleep Quality Index (PSQI) at Pregnancy visit 2
Participants will answer questions about their sleeping habits over the past week.
Time frame: ~35 weeks' gestation
Pittsburgh Sleep Quality Index (PSQI) at 1 month
Participants will answer questions about their sleeping habits over the past week.
Time frame: 1 month
Pittsburgh Sleep Quality Index (PSQI) at 6 months
Participants will answer questions about their sleeping habits over the past week.
Time frame: 6 months
Pittsburgh Sleep Quality Index (PSQI) at 12 months
Participants will answer questions about their sleeping habits over the past week.
Time frame: 12 months