ObesityNCT04674033
The Sweet PEA Study: Effects of Diet During Pregnancy on Infant Growth and Development.
An observational study of Obesity, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- Alcohol consumption during pregnancy (>1 drink per week)
- Infants:
- Presumed or known congenital birth defects
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
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
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.
Read the 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)
- Conditions
- Obesity
- Keywords
- Pregnancy, Nutrition, Obesity, Mother, Infant, Cognitive development, Growth
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Infant length at 1 Month
Infant length (cm) will be measured using an infant measure mat.
Measured: 1 month
Infant length at 6 Months
Infant length (cm) will be measured using an infant measure mat.
Measured: 6 months
Infant length at 12 Months
Infant length (cm) will be measured using an infant measure mat.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Infant body fat measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Measured: 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.
Measured: 12 months
Infant lean mass measured using an EchoMRI body composition analyzer at 1 month
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: 1 month
Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: 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.
Measured: 12 months
Infant total body water measured using an EchoMRI body composition analyzer at 1 month
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Infant free body water measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Measured: 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.
Measured: 12 months
Secondary outcomes (82)
Maternal height at 1 month
Height (cm) will be measured using a stadiometer.
Measured: 1 month
Maternal height at 6 months
Height (cm) will be measured using a stadiometer.
Measured: 6 months
Maternal height at 12 months
Height (cm) will be measured using a stadiometer.
Measured: 12 months
Maternal weight at 1 month
Weight (kg) will be measured using a portable digital scale.
Measured: 1 month
Maternal weight at 6 months
Weight (kg) will be measured using a portable digital scale.
Measured: 6 months
Maternal weight at 12 months
Weight (kg) will be measured using a portable digital scale.
Measured: 12 months
Maternal BMI at 1 Month
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
Measured: 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.
Measured: 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.
Measured: 12 months
Maternal blood glucose at Pregnancy visit 2
Mothers will self-report their most recent blood glucose levels.
Measured: ~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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 month
Maternal resting heart rate at 6 months
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Measured: 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).
Measured: 12 months
Maternal diet at Pregnancy visit 1
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR).
Measured: 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).
Measured: ~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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 1 month
Infant feeding score assessed by Infant Feeding Questionnaire at 6 months
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Measured: 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.
Measured: 12 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 1 month
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: 1 month
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: 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.
Measured: 12 months
Infant behavior score assessed by Infant Behavior Questionnaire at 1 month
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Measured: 1 month
Infant behavior score assessed by Infant Behavior Questionnaire at 6 months
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Measured: 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.
Measured: 12 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 1 month
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Measured: 1 month
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Measured: 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.
Measured: 12 months
Breast milk composition at 1 month
Breast milk will be collected from mothers at least 11⁄2 hours since the last feeding and while the mother has fasted at least 1 hour. Samples will be analyzed for glucose, fructose, galactose, lactose and sucrose by mass spectrometry. Samples will be available for analysis of insulin, leptin, and energy content.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Infant Magnetic Resonance Imaging (MRI) brain scan at 6 months
Infant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.
Measured: 6 months
Infant gut microbiome at 1 Month
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Maternal gut microbiome at 6 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 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.
Measured: 12 months
Infant Diet and Behavior Questionnaire at 1 month
Participants will report when they stopped breastfeeding/introduced formula or solid foods.
Measured: 1 month
Infant Diet and Behavior Questionnaire at 6 months
Participants will report when they stopped breastfeeding/introduced formula or solid foods.
Measured: 6 months
Infant Diet and Behavior Questionnaire at 12 months
Participants will report when they stopped breastfeeding/introduced formula or solid foods.
Measured: 12 months
CDC Infant Feeding Practices Survey II at 1 month
Participants will answer questions about their and their infant's diet.
Measured: 1 month
CDC Infant Feeding Practices Survey II at 6 months
Participants will answer questions about their and their infant's diet.
Measured: 6 months
CDC Infant Feeding Practices Survey II at 12 months
Participants will answer questions about their and their infant's diet.
Measured: 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.
Measured: 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.
Measured: ~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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: ~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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: ~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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: ~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.
Measured: 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.
Measured: 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.
Measured: 12 months
Pittsburgh Sleep Quality Index (PSQI) at Pregnancy visit 1
Participants will answer questions about their sleeping habits over the past week.
Measured: 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.
Measured: ~35 weeks' gestation
Pittsburgh Sleep Quality Index (PSQI) at 1 month
Participants will answer questions about their sleeping habits over the past week.
Measured: 1 month
Pittsburgh Sleep Quality Index (PSQI) at 6 months
Participants will answer questions about their sleeping habits over the past week.
Measured: 6 months
Pittsburgh Sleep Quality Index (PSQI) at 12 months
Participants will answer questions about their sleeping habits over the past week.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start18 Jan 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Michael I. Goran, University of Southern California
- Investigators
- Michael I Goran, Principal investigator, University of Southern California; Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674033
- Sponsor's protocol ID
- CHLA-18-00455
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04674033
- Acronym / sponsor ID
- CHLA-18-00455
- Conditions
- Obesity
- Keywords
- Pregnancy, Nutrition, Obesity, Mother, Infant, Cognitive development, Growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Sweet PEA Study is to determine whether diet during pregnancy has an effect on infant's growth, body composition, and brain development.
Detailed description
Rationale: Non-nutritive sweetener (NNS) consumption during pregnancy is prevalent, but effects on maternal and infant health are not well known. Intervention: None Objectives: To determine whether NNS consumption during pregnancy is associated with increased infant body fat, as well as differences in infant growth, brain structure/function, gut microbiota, and gestational diabetes. Study population: Women prior to 28 weeks' gestation, determined to have either low/no NNS consumption (control) or high NNS consumption (experimental), based on a pre-screening survey. Methodology: Identify two groups (low/high consumers) in early pregnancy, collect data during pregnancy remotely (telephone, internet, medical records) to determine diet and any link to pregnancy complications, have in-person visits with mothers/infants at 1, 6, and 12 months of age, collecting: body composition data (by EchoMRI), brain structure/connectivity (MRI), stool samples. Outcomes: Primary outcome is infant adiposity at 1, 6, and 12 months. Additional measures include infant growth, feeding behaviors, brain structure/ connectivity, gut microbiota, and maternal metabolic outcomes during routine gestational testing (fasting glucose, insulin, triglycerides, gestational diabetes diagnosis) Follow-up: This will operate as a small pilot study, and a larger study with more participants, a wider spectrum of NNS exposure, and longer follow up (into childhood and beyond) may follow. Statistics: Multivariate linear mixed effects examining maternal NNS intake and outcomes across time (repeated measures)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
82 secondary outcomes
Maternal height at 1 month
Time frame: 1 month
Maternal height at 6 months
Time frame: 6 months
Maternal height at 12 months
Time frame: 12 months
Maternal weight at 1 month
Time frame: 1 month
Maternal weight at 6 months
Time frame: 6 months
Maternal weight at 12 months
Time frame: 12 months
Maternal BMI at 1 Month
Time frame: 1 month
Maternal BMI at 6 Months
Time frame: 6 months
Maternal BMI at 12 Months
Time frame: 12 months
Maternal blood glucose at Pregnancy visit 2
Time frame: ~35 weeks' gestation
Maternal pregravid BMI
Time frame: 24-28 weeks' gestation
Maternal blood pressure at 1 month
Time frame: 1 month
Maternal blood pressure at 6 months
Time frame: 6 months
Maternal blood pressure at 12 months
Time frame: 12 months
Maternal resting heart rate at 1 month
Time frame: 1 month
Maternal resting heart rate at 6 months
Time frame: 6 months
Maternal resting heart rate at 12 months
Time frame: 12 months
Maternal diet at Pregnancy visit 1
Time frame: 24-28 weeks' gestation
Maternal diet at Pregnancy visit 2
Time frame: ~35 weeks' gestation
Maternal diet at 1 month
Time frame: 1 month
Maternal diet at 6 months
Time frame: 6 months
Maternal diet at 12 months
Time frame: 12 months
Infant diet at 1 month
Time frame: 1 month
Infant diet at 6 months
Time frame: 6 months
Infant diet at 12 months
Time frame: 12 months
Infant feeding score assessed by Infant Feeding Questionnaire at 1 month
Time frame: 1 month
Infant feeding score assessed by Infant Feeding Questionnaire at 6 months
Time frame: 6 months
Infant feeding score assessed by Infant Feeding Questionnaire at 12 months
Time frame: 12 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 1 month
Time frame: 1 month
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months
Time frame: 6 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months
Time frame: 12 months
Infant behavior score assessed by Infant Behavior Questionnaire at 1 month
Time frame: 1 month
Infant behavior score assessed by Infant Behavior Questionnaire at 6 months
Time frame: 6 months
Infant behavior score assessed by Infant Behavior Questionnaire at 12 months
Time frame: 12 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 1 month
Time frame: 1 month
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months
Time frame: 6 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 12 months
Time frame: 12 months
Breast milk composition at 1 month
Time frame: 1 month
Breast milk composition at 6 months
Time frame: 6 months
Breast milk composition at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael I Goran principal investigator
University of Southern California; Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant length at 1 Month (time frame: 1 month). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.