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

December 3, 2024 updated by: Michael I. Goran, University of Southern California

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
12 months
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.
6 months
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.
12 months
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.
6 months
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.
12 months
Infant length at 1 Month
Time Frame: 1 month
Infant length (cm) will be measured using an infant measure mat.
1 month
Infant length at 6 Months
Time Frame: 6 months
Infant length (cm) will be measured using an infant measure mat.
6 months
Infant length at 12 Months
Time Frame: 12 months
Infant length (cm) will be measured using an infant measure mat.
12 months
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).
1 month
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).
6 months
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).
12 months
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.
1 month
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.
6 months
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.
12 months
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.
1 month
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.
1 month
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.
1 month
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.
6 month
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.
12 month
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.
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal height at 6 months
Time Frame: 6 months
Height (cm) will be measured using a stadiometer.
6 months
Maternal height at 12 months
Time Frame: 12 months
Height (cm) will be measured using a stadiometer.
12 months
Maternal weight at 6 months
Time Frame: 6 months
Weight (kg) will be measured using a portable digital scale.
6 months
Maternal weight at 12 months
Time Frame: 12 months
Weight (kg) will be measured using a portable digital scale.
12 months
Maternal resting heart rate at 6 months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 1 month
Height (cm) will be measured using a stadiometer.
1 month
Maternal weight at 1 month
Time Frame: 1 month
Weight (kg) will be measured using a portable digital scale.
1 month
Maternal BMI at 1 Month
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: ~35 weeks' gestation
Mothers will self-report their most recent blood glucose levels.
~35 weeks' gestation
Maternal pregravid BMI
Time Frame: 24-28 weeks' gestation
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 24-28 weeks' gestation
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
Time Frame: ~35 weeks' gestation
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 1 month
Participants will report when they stopped breastfeeding/introduced formula or solid foods.
1 month
Infant Diet and Behavior Questionnaire at 6 months
Time Frame: 6 months
Participants will report when they stopped breastfeeding/introduced formula or solid foods.
6 months
Infant Diet and Behavior Questionnaire at 12 months
Time Frame: 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
Time Frame: 1 month
Participants will answer questions about their and their infant's diet.
1 month
CDC Infant Feeding Practices Survey II at 6 months
Time Frame: 6 months
Participants will answer questions about their and their infant's diet.
6 months
CDC Infant Feeding Practices Survey II at 12 months
Time Frame: 12 months
Participants will answer questions about their and their infant's diet.
12 months
Maternal Beverage Recall at Pregnancy visit 1
Time Frame: 24-28 weeks' gestation
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
Time Frame: ~35 weeks' gestation
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 24-28 weeks' gestation
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
Time Frame: ~35 weeks' gestation
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 24-28 weeks' gestation
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
Time Frame: ~35 weeks' gestation
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 24-28 weeks' gestation
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
Time Frame: ~35 weeks' gestation
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 24-28 weeks' gestation
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
Time Frame: ~35 weeks' gestation
Participants will answer questions about their sleeping habits over the past week.
~35 weeks' gestation
Pittsburgh Sleep Quality Index (PSQI) at 1 month
Time Frame: 1 month
Participants will answer questions about their sleeping habits over the past week.
1 month
Pittsburgh Sleep Quality Index (PSQI) at 6 months
Time Frame: 6 months
Participants will answer questions about their sleeping habits over the past week.
6 months
Pittsburgh Sleep Quality Index (PSQI) at 12 months
Time Frame: 12 months
Participants will answer questions about their sleeping habits over the past week.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael I Goran, University of Southern California; Children's Hospital Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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