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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674033
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Michael I. Goran, University of Southern California

Tracking Information
First Submitted Date December 8, 2020
First Posted Date December 17, 2020
Last Update Posted Date December 17, 2020
Actual Study Start Date January 18, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2020)
  • Infant length at 1 Month [ Time Frame: 1 month ]
    Infant length (cm) will be measured using an infant measure mat.
  • Infant length at 6 Months [ Time Frame: 6 months ]
    Infant length (cm) will be measured using an infant measure mat.
  • Infant length at 12 Months [ Time Frame: 12 months ]
    Infant length (cm) will be measured using an infant measure mat.
  • Infant weight at 1 Month [ Time Frame: 1 month ]
    Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
  • Infant weight at 6 Months [ Time Frame: 6 months ]
    Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
  • Infant weight at 12 Months [ Time Frame: 12 months ]
    Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
  • Infant weight z-scores at 1 Month [ Time Frame: 1 month ]
    Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
  • Infant weight z-scores at 6 Months [ Time Frame: 6 months ]
    Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
  • Infant weight z-scores at 12 Months [ Time Frame: 12 months ]
    Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
  • Infant body fat measured using an EchoMRI body composition analyzer at 1 month [ Time Frame: 1 month ]
    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
  • Infant body fat measured using an EchoMRI body composition analyzer at 6 months [ Time Frame: 6 months ]
    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
  • Infant body fat measured using an EchoMRI body composition analyzer at 12 months [ Time Frame: 12 months ]
    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
  • Infant lean mass measured using an EchoMRI body composition analyzer at 1 month [ Time Frame: 1 month ]
    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
  • Infant lean mass measured using an EchoMRI body composition analyzer at 6 months [ Time Frame: 6 months ]
    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
  • Infant 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.
  • Infant total body water measured using an EchoMRI body composition analyzer at 1 month [ Time Frame: 1 month ]
    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
  • Infant total body water measured using an EchoMRI body composition analyzer at 6 months [ Time Frame: 6 month ]
    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
  • Infant total body water measured using an EchoMRI body composition analyzer at 12 months [ Time Frame: 12 month ]
    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
  • Infant free body water measured using an EchoMRI body composition analyzer at 1 month [ Time Frame: 1 month ]
    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
  • Infant free body water measured using an EchoMRI body composition analyzer at 6 months [ Time Frame: 6 months ]
    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
  • Infant 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 14, 2020)
  • Maternal height at 1 month [ Time Frame: 1 month ]
    Height (cm) will be measured using a stadiometer.
  • Maternal height at 6 months [ Time Frame: 6 months ]
    Height (cm) will be measured using a stadiometer.
  • Maternal height at 12 months [ Time Frame: 12 months ]
    Height (cm) will be measured using a stadiometer.
  • Maternal weight at 1 month [ Time Frame: 1 month ]
    Weight (kg) will be measured using a portable digital scale.
  • Maternal weight at 6 months [ Time Frame: 6 months ]
    Weight (kg) will be measured using a portable digital scale.
  • Maternal weight at 12 months [ Time Frame: 12 months ]
    Weight (kg) will be measured using a portable digital scale.
  • 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.
  • 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.
  • 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.
  • Maternal blood glucose at Pregnancy visit 2 [ Time Frame: ~35 weeks' gestation ]
    Mothers will self-report their most recent blood glucose levels.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Infant Diet and Behavior Questionnaire at 1 month [ Time Frame: 1 month ]
    Participants will report when they stopped breastfeeding/introduced formula or solid foods.
  • Infant Diet and Behavior Questionnaire at 6 months [ Time Frame: 6 months ]
    Participants will report when they stopped breastfeeding/introduced formula or solid foods.
  • Infant Diet and Behavior Questionnaire at 12 months [ Time Frame: 12 months ]
    Participants will report when they stopped breastfeeding/introduced formula or solid foods.
  • CDC Infant Feeding Practices Survey II at 1 month [ Time Frame: 1 month ]
    Participants will answer questions about their and their infant's diet.
  • CDC Infant Feeding Practices Survey II at 6 months [ Time Frame: 6 months ]
    Participants will answer questions about their and their infant's diet.
  • CDC Infant Feeding Practices Survey II at 12 months [ Time Frame: 12 months ]
    Participants will answer questions about their and their infant's diet.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Pittsburgh Sleep Quality Index (PSQI) at 1 month [ Time Frame: 1 month ]
    Participants will answer questions about their sleeping habits over the past week.
  • Pittsburgh Sleep Quality Index (PSQI) at 6 months [ Time Frame: 6 months ]
    Participants will answer questions about their sleeping habits over the past week.
  • Pittsburgh Sleep Quality Index (PSQI) at 12 months [ Time Frame: 12 months ]
    Participants will answer questions about their sleeping habits over the past week.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Sweet PEA Study: Effects of Diet During Pregnancy on Infant Growth and Development.
Official Title The Sweet PEA Study: a Pilot Study of the Impact of Non-nutritive Sweetener Consumption During Pregnancy on Maternal and Infant Metabolic Health
Brief Summary The purpose of the Sweet PEA Study is to determine whether diet during pregnancy has an effect on infant's growth, body composition, and brain development.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Breast milk; Stool
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.
Condition Obesity
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 14, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Mothers:

  • Pregnant women prior to 28 weeks gestation
  • Report the least NNS consumption of pre-screened participants (0 servings per week - representing the control group) and most NNS consumption of pre-screened participants (≥ 5 servings per week - representing the experimental group).
  • 18-40 years of age
  • Singleton pregnancy
  • Be able/willing to understand the procedures of the study
  • Be able to read English at a 5th grade level (materials also available in Spanish, if required)

Infants:

  • Infant's mother must be enrolled in the study and provide infant assent to participate

Exclusion Criteria:

Mothers:

  • Physician diagnosis of a major medical illness
  • Pre-existing diabetes (type 1 or type 2), or GDM in a previous pregnancy
  • Physical, mental, or cognitive issues preventing participation
  • Medications that may affect body weight, body composition, insulin resistance, or lipid profiles
  • Tobacco or drug use (any current use or quitting during pregnancy)
  • Alcohol consumption during pregnancy (>1 drink per week)

Infants:

  • Presumed or known congenital birth defects
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Michael I Goran 323-361-8571 goran@usc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04674033
Other Study ID Numbers CHLA-18-00455
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Michael I. Goran, University of Southern California
Study 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
PRS Account University of Southern California
Verification Date December 2020