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

The Sweet PEA Study: a Pilot Study of the Impact of Non-nutritive Sweetener Consumption During Pregnancy on Maternal and Infant Metabolic Health

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.

Study Overview

• Status: Completed
• Conditions: Obesity

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)

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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
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 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 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal height at 6 months	Height (cm) will be measured using a stadiometer.	6 months
Maternal height at 12 months	Height (cm) will be measured using a stadiometer.	12 months
Maternal weight at 6 months	Weight (kg) will be measured using a portable digital scale.	6 months
Maternal weight at 12 months	Weight (kg) will be measured using a portable digital scale.	12 months
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).	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).	12 months
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.	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.	12 months
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.	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.	12 months
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.	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.	12 months
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.	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.	12 months
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.	6 months
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.	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.	12 months
Maternal height at 1 month	Height (cm) will be measured using a stadiometer.	1 month
Maternal weight at 1 month	Weight (kg) will be measured using a portable digital scale.	1 month
Maternal BMI at 1 Month	Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.	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.	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.	12 months
Maternal blood glucose at Pregnancy visit 2	Mothers will self-report their most recent blood glucose levels.	~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.	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).	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).	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).	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).	1 month
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).	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).	~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).	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).	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).	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).	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).	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).	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.	1 month
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.	1 month
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.	1 month
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.	1 month
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.	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.	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.	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.	1 month
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.	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.	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.	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.	1 month
Infant Diet and Behavior Questionnaire at 1 month	Participants will report when they stopped breastfeeding/introduced formula or solid foods.	1 month
Infant Diet and Behavior Questionnaire at 6 months	Participants will report when they stopped breastfeeding/introduced formula or solid foods.	6 months
Infant Diet and Behavior Questionnaire at 12 months	Participants will report when they stopped breastfeeding/introduced formula or solid foods.	12 months
CDC Infant Feeding Practices Survey II at 1 month	Participants will answer questions about their and their infant's diet.	1 month
CDC Infant Feeding Practices Survey II at 6 months	Participants will answer questions about their and their infant's diet.	6 months
CDC Infant Feeding Practices Survey II at 12 months	Participants will answer questions about their and their infant's diet.	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.	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.	~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.	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.	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.	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.	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.	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.	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.	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.	~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.	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.	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.	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.	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.	~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.	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.	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.	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.	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.	~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.	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.	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.	12 months
Pittsburgh Sleep Quality Index (PSQI) at Pregnancy visit 1	Participants will answer questions about their sleeping habits over the past week.	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.	~35 weeks' gestation
Pittsburgh Sleep Quality Index (PSQI) at 1 month	Participants will answer questions about their sleeping habits over the past week.	1 month
Pittsburgh Sleep Quality Index (PSQI) at 6 months	Participants will answer questions about their sleeping habits over the past week.	6 months
Pittsburgh Sleep Quality Index (PSQI) at 12 months	Participants will answer questions about their sleeping habits over the past week.	12 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Michael I Goran, University of Southern California; Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Pregnancy; Nutrition; Growth; Infant; Cognitive development; Mother
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: CHLA-18-00455

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No