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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04674033
Enrollment
93
Registered
2020-12-17
Start date
2019-01-18
Completion date
2020-07-01
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Pregnancy, Nutrition, Obesity, Mother, Infant, Cognitive development, Growth

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

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)

Interventions

None listed

Sponsors

Children's Hospital Los Angeles
CollaboratorOTHER
University of Southern California
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Infant length at 12 Months12 monthsInfant length (cm) will be measured using an infant measure mat.
Infant length at 1 Month1 monthInfant length (cm) will be measured using an infant measure mat.
Infant length at 6 Months6 monthsInfant length (cm) will be measured using an infant measure mat.
Infant weight at 1 Month1 monthInfant 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 Months6 monthsInfant 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 Months12 monthsInfant 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 Month1 monthWeight 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 Months6 monthsWeight 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 Months12 monthsWeight 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 month1 monthAn 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 months6 monthsAn 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 months12 monthsAn 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 month1 monthAn 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 months6 monthsAn 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 months12 monthsAn 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 month1 monthAn 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 months6 monthAn 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 months12 monthAn 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 month1 monthAn 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 months6 monthsAn 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 months12 monthsAn EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

Secondary

MeasureTime frameDescription
Maternal diet at 12 months12 months24-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 month1 month24-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 months6 months24-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 months12 months24-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 month1 monthInfant 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 months6 monthsInfant 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 months12 monthsInfant 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 month1 monthInfant 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 months6 monthsInfant 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 months12 monthsInfant 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 month1 monthInfant 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 months6 monthsInfant 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 months12 monthsInfant 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 month1 monthInfant 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 months6 monthsInfant 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 months12 monthsInfant 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 month1 monthBreast 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 months6 monthsBreast 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 months12 monthsBreast 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 month1 monthInfant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.
Infant Magnetic Resonance Imaging (MRI) brain scan at 6 months6 monthsInfant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.
Infant gut microbiome at 1 Month1 monthStool 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 Months6 monthsStool 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 Months12 monthsStool 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 month1 monthStool 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 months6 monthsStool 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 months12 monthsStool 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 month1 monthParticipants will report when they stopped breastfeeding/introduced formula or solid foods.
Infant Diet and Behavior Questionnaire at 6 months6 monthsParticipants will report when they stopped breastfeeding/introduced formula or solid foods.
Infant Diet and Behavior Questionnaire at 12 months12 monthsParticipants will report when they stopped breastfeeding/introduced formula or solid foods.
CDC Infant Feeding Practices Survey II at 1 month1 monthParticipants will answer questions about their and their infant's diet.
CDC Infant Feeding Practices Survey II at 6 months6 monthsParticipants will answer questions about their and their infant's diet.
CDC Infant Feeding Practices Survey II at 12 months12 monthsParticipants will answer questions about their and their infant's diet.
Maternal Beverage Recall at Pregnancy visit 124-28 weeks' gestationParticipants 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 2~35 weeks' gestationParticipants 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 month1 monthParticipants 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 months6 monthsParticipants 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 months12 monthsParticipants 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 month1 monthMother'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 months6 monthsMother'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 months12 monthsMother'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 124-28 weeks' gestationParticipants will answer questions regarding their stress levels during and after pregnancy. Minimum = 0; maximum = 93. Higher scores represent worse outcomes.
Maternal height at 1 month1 monthHeight (cm) will be measured using a stadiometer.
Perinatal Anxiety Screening Scale (PASS) at 1 month1 monthParticipants 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 months6 monthsParticipants 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 months12 monthsParticipants 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 124-28 weeks' gestationParticipants 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 2~35 weeks' gestationParticipants will answer questions regarding their feelings and mood. Minimum = 0, maximum = 30. Higher scores represent worse outcomes.
Edinburgh Postnatal Depression Scale (EPDS) at 1 month1 monthParticipants will answer questions regarding their feelings and mood. Minimum = 0, maximum = 30. Higher scores represent worse outcomes.
Edinburgh Postnatal Depression Scale (EPDS) at 6 months6 monthsParticipants will answer questions regarding their feelings and mood. Minimum = 0, maximum = 30. Higher scores represent worse outcomes.
Edinburgh Postnatal Depression Scale (EPDS) at 12 months12 monthsParticipants will answer questions regarding their feelings and mood. Minimum = 0, maximum = 30. Higher scores represent worse outcomes.
Pregnancy Physical Activity Questionnaire at Pregnancy visit 124-28 weeks' gestationParticipants 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 2~35 weeks' gestationParticipants 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 month1 monthParticipants 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 months6 monthsParticipants 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 months12 monthsParticipants 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 124-28 weeks' gestationParticipants will answer questions about their sleeping habits over the past week.
Pittsburgh Sleep Quality Index (PSQI) at Pregnancy visit 2~35 weeks' gestationParticipants will answer questions about their sleeping habits over the past week.
Pittsburgh Sleep Quality Index (PSQI) at 1 month1 monthParticipants will answer questions about their sleeping habits over the past week.
Pittsburgh Sleep Quality Index (PSQI) at 6 months6 monthsParticipants will answer questions about their sleeping habits over the past week.
Pittsburgh Sleep Quality Index (PSQI) at 12 months12 monthsParticipants will answer questions about their sleeping habits over the past week.
Perinatal Anxiety Screening Scale (PASS) at Pregnancy visit 2~35 weeks' gestationParticipants will answer questions regarding their stress levels during and after pregnancy. Minimum = 0; maximum = 93. Higher scores represent worse outcomes.
Maternal height at 6 months6 monthsHeight (cm) will be measured using a stadiometer.
Maternal height at 12 months12 monthsHeight (cm) will be measured using a stadiometer.
Maternal weight at 1 month1 monthWeight (kg) will be measured using a portable digital scale.
Maternal weight at 6 months6 monthsWeight (kg) will be measured using a portable digital scale.
Maternal weight at 12 months12 monthsWeight (kg) will be measured using a portable digital scale.
Maternal BMI at 1 Month1 monthBody Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.
Maternal BMI at 6 Months6 monthsBody Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.
Maternal BMI at 12 Months12 monthsBody Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.
Maternal blood glucose at Pregnancy visit 2~35 weeks' gestationMothers will self-report their most recent blood glucose levels.
Maternal pregravid BMI24-28 weeks' gestationMaternal 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 month1 monthSitting 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 months6 monthsSitting 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 months12 monthsSitting 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 month1 monthSitting 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 months6 monthsSitting 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 months12 monthsSitting 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 124-28 weeks' gestation24-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 2~35 weeks' gestation24-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 month1 month24-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 months6 months24-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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026