<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04434027</url>
  </required_header>
  <id_info>
    <org_study_id>CHLA-18-00576</org_study_id>
    <nct_id>NCT04434027</nct_id>
  </id_info>
  <brief_title>The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development</brief_title>
  <official_title>Mother's Milk Study: Determining the Impact of Human Milk Oligosaccharides (HMOs) on Healthy Infant Growth and Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the effects of breastfeeding and breastmilk composition on infant&#xD;
      gut microbiome development as well as obesity and cognitive outcomes. Breast milk contains&#xD;
      certain natural sugars that can promote the growth of 'good' bacteria in the intestines and&#xD;
      reduce the growth of harmful bacteria. The purpose of this study is to look at the effects of&#xD;
      these natural sugars in breast milk on the infant's bacteria and the impact of this on&#xD;
      development of obesity and cognitive outcomes by 2 years of age with plans for longer term&#xD;
      follow up contingent upon funding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project will examine specific factors in breast milk that may impact infant's gut&#xD;
      microbiome development, and thereby impact their adiposity and weight gain in early life. An&#xD;
      important early-life experience that could meaningfully impact the development of the gut&#xD;
      microbiome, as well as future obesity risk, is breastfeeding. Breast milk has been shown to&#xD;
      contain certain macronutrients (human milk oligosaccharides; HMOs) that not only vary greatly&#xD;
      among women, but recent studies suggest that these factors are significant predictors of&#xD;
      infant weight gain and adiposity. Examining early onset obesity during infancy is important&#xD;
      because accelerated weight gain and adiposity in the first few years of life are major&#xD;
      predictors for later obesity, and because neuronal, metabolic, and gut microbiome systems are&#xD;
      especially vulnerable by programming from nutritional and maternal factors during this stage&#xD;
      of life.&#xD;
&#xD;
      This study will be conducted in Los Angeles. The investigators will recruit&#xD;
      two-hundred-and-forty mother-infant pairs. Mothers and infants will be monitored during the&#xD;
      first 36 months of life, with sampling of breast milk (while the mother is still breast&#xD;
      feeding) and infant and maternal stool at 1, 6, 12, 18, and 24 months of age (or as close as&#xD;
      possible to each month). Only an infant stool sample will be collected at 36 months of age.&#xD;
      The main outcomes of this study will be infant body weight-for-length growth during this&#xD;
      period, as well as body composition (fat and lean mass), which will be measured by skin-fold&#xD;
      thickness using a caliber, height, weight, and waist circumference measurements at 1, 6, 12,&#xD;
      18, 24, and 36 months of infant age (or as close as possible to each month). The&#xD;
      investigators will also assess maternal and infant diet using 24-hour recalls, and maternal&#xD;
      feeding style and infant eating behaviors using questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Infant weight z-scores at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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 &lt;24 mos.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant weight z-scores at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>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 &lt;24 mos.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant weight z-scores at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>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 &lt;24 mos.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant weight z-scores at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>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 &lt;24 mos.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant weight z-scores at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>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 &lt;24 mos.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant weight z-scores at 36 months</measure>
    <time_frame>36 months</time_frame>
    <description>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 &lt;24 mos.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant skinfold thickness at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant skinfold thickness at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant skinfold thickness at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant skinfold thickness at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant skinfold thickness at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant skinfold thickness at 36 months</measure>
    <time_frame>36 months</time_frame>
    <description>Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant body fat measured using an EchoMRI body composition analyzer at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant body fat measured using an EchoMRI body composition analyzer at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant body fat measured using an EchoMRI body composition analyzer at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant body fat measured using an EchoMRI body composition analyzer at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant body fat measured using an EchoMRI body composition analyzer at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant lean mass measured using an EchoMRI body composition analyzer at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant lean mass measured using an EchoMRI body composition analyzer at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant lean mass measured using an EchoMRI body composition analyzer at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant lean mass measured using an EchoMRI body composition analyzer at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant lean mass measured using an EchoMRI body composition analyzer at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant total body water measured using an EchoMRI body composition analyzer at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant total body water measured using an EchoMRI body composition analyzer at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant total body water measured using an EchoMRI body composition analyzer at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant total body water measured using an EchoMRI body composition analyzer at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant total body water measured using an EchoMRI body composition analyzer at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant free body water measured using an EchoMRI body composition analyzer at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant free body water measured using an EchoMRI body composition analyzer at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant free body water measured using an EchoMRI body composition analyzer at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant free body water measured using an EchoMRI body composition analyzer at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant free body water measured using an EchoMRI body composition analyzer at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal pregravid BMI</measure>
    <time_frame>Baseline</time_frame>
    <description>Maternal BMI prior to pregnancy will be derived from pregravid BMI (recall during pregnancy at baseline visit) using the equation (weight in kg)/(height in m)^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal height at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Height (cm) will be measured using a stadiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal height at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Height (cm) will be measured using a stadiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal height at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Height (cm) will be measured using a stadiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal height at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Height (cm) will be measured using a stadiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal height at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Height (cm) will be measured using a stadiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal weight at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Weight (kg) will be measured using a portable digital scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal weight at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Weight (kg) will be measured using a portable digital scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal weight at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Weight (kg) will be measured using a portable digital scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal weight at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Weight (kg) will be measured using a portable digital scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal weight at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Weight (kg) will be measured using a portable digital scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal BMI at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal BMI at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal BMI at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal BMI at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal BMI at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant length at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Infant length (cm) will be measured using an infant measure mat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant length at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Infant length (cm) will be measured using an infant measure mat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant length at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Infant length (cm) will be measured using an infant measure mat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant length at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Infant length (cm) will be measured using an infant measure mat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant length at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Infant length (cm) will be measured using an infant measure mat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant length at 36 months</measure>
    <time_frame>36 months</time_frame>
    <description>Infant length (cm) will be measured using an infant measure mat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant weight at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant weight at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant weight at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant weight at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant weight at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant weight at 36 months</measure>
    <time_frame>36 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal systolic and diastolic blood pressure at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Sitting systolic and diastolic 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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal systolic and diastolic blood pressure at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Sitting systolic and diastolic 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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal systolic and diastolic blood pressure at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Sitting systolic and diastolic 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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal systolic and diastolic blood pressure at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Sitting systolic and diastolic 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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal systolic and diastolic blood pressure at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Sitting systolic and diastolic 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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal resting heart rate at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal resting heart rate at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal resting heart rate at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal resting heart rate at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal resting heart rate at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diet at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diet at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diet at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diet at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diet at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet at 36 months</measure>
    <time_frame>36 months</time_frame>
    <description>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) which has been used extensively in Hispanic studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal beverage recall during last trimester of pregnancy</measure>
    <time_frame>Baseline</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for a typical week during the last trimester of pregnancy. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal beverage recall at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal beverage recall at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal beverage recall at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal beverage recall at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal beverage recall at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant beverage recall at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant beverage recall at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant beverage recall at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant beverage recall at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant beverage recall at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant beverage recall at 36 months</measure>
    <time_frame>36 months</time_frame>
    <description>Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant feeding score assessed by Infant Feeding Questionnaire at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant feeding score assessed by Infant Feeding Questionnaire at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant feeding score assessed by Infant Feeding Questionnaire at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant feeding score assessed by Infant Feeding Questionnaire at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant feeding score assessed by Infant Feeding Questionnaire at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant feeding style score assessed by Infant Feeding Style Questionnaire at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant feeding style score assessed by Infant Feeding Style Questionnaire at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant feeding style score assessed by Infant Feeding Style Questionnaire at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant behavior score assessed by Infant Behavior Questionnaire at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant behavior score assessed by Infant Behavior Questionnaire at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant behavior score assessed by Infant Behavior Questionnaire at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant behavior score assessed by Infant Behavior Questionnaire at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant behavior score assessed by Infant Behavior Questionnaire at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet score assessed by Infant Diet Questionnaire at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Infant diet will be assessed using a questionnaire which inquires about breastfeeding frequency and duration, formula type/brand/frequency, and consumption of fruit, vegetables, meat, fried foods, juice, and sweetened drinks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet score assessed by Infant Diet Questionnaire at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Infant diet will be assessed using a questionnaire which inquires about breastfeeding frequency and duration, formula type/brand/frequency, and consumption of fruit, vegetables, meat, fried foods, juice, and sweetened drinks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet score assessed by Infant Diet Questionnaire at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Infant diet will be assessed using a questionnaire which inquires about breastfeeding frequency and duration, formula type/brand/frequency, and consumption of fruit, vegetables, meat, fried foods, juice, and sweetened drinks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet score assessed by Infant Diet Questionnaire at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Infant diet will be assessed using a questionnaire which inquires about breastfeeding frequency and duration, formula type/brand/frequency, and consumption of fruit, vegetables, meat, fried foods, juice, and sweetened drinks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant diet score assessed by Infant Diet Questionnaire at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Infant diet will be assessed using a questionnaire which inquires about breastfeeding frequency and duration, formula type/brand/frequency, and consumption of fruit, vegetables, meat, fried foods, juice, and sweetened drinks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant development assessed by the Bayley Scales of Infant and Toddler Development at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Infant development will be assessed using the Bayley Scales of Infant and Toddler Development - Third Edition (BSID-3). This test is designed to assess cognitive, language, motor, social-emotional, and adaptive behavior development in infants and toddlers. This test will be administered and interpreted by trained research personnel. Subscale scores each range from 1 - 19, with higher scores indicating higher performance. Scores from 8 to 12 are considered average.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Magnetic Resonance Imaging (MRI) brain scan at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Infant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Magnetic Resonance Imaging (MRI) brain scan at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Infant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant development assessed by the Adaptive Behavior Assessment System at 36 months</measure>
    <time_frame>36 months</time_frame>
    <description>Infant emotional and adaptive development will be assessed using the Adaptive Behavior Assessment System (ABAS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast milk composition at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Breast milk will be collected from mothers at least 1½ 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast milk composition at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Breast milk will be collected from mothers at least 1½ 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast milk composition at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Breast milk will be collected from mothers at least 1½ 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast milk composition at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Breast milk will be collected from mothers at least 1½ 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast milk composition at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Breast milk will be collected from mothers at least 1½ 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant gut microbiome at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant gut microbiome at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant gut microbiome at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant gut microbiome at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant gut microbiome at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant gut microbiome at 36 months</measure>
    <time_frame>36 months</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal gut microbiome at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal gut microbiome at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal gut microbiome at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal gut microbiome at 18 months</measure>
    <time_frame>18 months</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal gut microbiome at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.</description>
  </secondary_outcome>
  <enrollment type="Actual">221</enrollment>
  <condition>Obesity</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Breast milk; Stool (mother and infant)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Normal, overweight or obese (&gt;25 BMI kg/m2) non-diabetic Hispanic mothers (18-59yrs) and&#xD;
        their infants (&lt;1-36 months) from Los Angeles, CA.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers who self-identify as Hispanic&#xD;
&#xD;
          -  Mothers who have or have had singleton births&#xD;
&#xD;
          -  Mothers will be recruited prior to their infant's birth or up to 1-month postpartum&#xD;
&#xD;
          -  Mothers must be able/willing to understand the procedures of the study, and must be&#xD;
             able to read English or Spanish at a 5th grade level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes)&#xD;
             or eating disorder in mothers&#xD;
&#xD;
          -  Physical, mental, or cognitive issues that prevent participation&#xD;
&#xD;
          -  Chronic use of any medication that may affect body weight or composition, insulin&#xD;
             resistance, or lipid profiles&#xD;
&#xD;
          -  Current smoking (more than 1 cigarette in the past week) or use of other recreational&#xD;
             drugs&#xD;
&#xD;
          -  Clinical diagnosis of gestational diabetes&#xD;
&#xD;
          -  Pre-term/low birth weight infants, or diagnosis of any fetal abnormalities&#xD;
&#xD;
          -  Mothers less than 18 years of age at the time of delivery will not be eligible as to&#xD;
             avoid potential confounding from those subjects who might still be completing&#xD;
             adolescent growth&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael I Goran, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California; Children's Hospital Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Michael I. Goran</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>microbiome</keyword>
  <keyword>nutrition</keyword>
  <keyword>obesity</keyword>
  <keyword>growth</keyword>
  <keyword>breastfeeding</keyword>
  <keyword>mother</keyword>
  <keyword>infant</keyword>
  <keyword>cognitive development</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434027
org study id: CHLA-18-00576
nct id: NCT04434027
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study will investigate the effects of breastfeeding and breastmilk composition on infant
      gut microbiome development as well as obesity and cognitive outcomes. Breast milk contains
      certain natural sugars that can promote the growth of 'good' bacteria in the intestines and
      reduce the growth of harmful bacteria. The purpose of this study is to look at the effects of
      these natural sugars in breast milk on the infant's bacteria and the impact of this on
      development of obesity and cognitive outcomes by 2 years of age with plans for longer term
      follow up contingent upon funding.
This project will examine specific factors in breast milk that may impact infant's gut
      microbiome development, and thereby impact their adiposity and weight gain in early life. An
      important early-life experience that could meaningfully impact the development of the gut
      microbiome, as well as future obesity risk, is breastfeeding. Breast milk has been shown to
      contain certain macronutrients (human milk oligosaccharides; HMOs) that not only vary greatly
      among women, but recent studies suggest that these factors are significant predictors of
      infant weight gain and adiposity. Examining early onset obesity during infancy is important
      because accelerated weight gain and adiposity in the first few years of life are major
      predictors for later obesity, and because neuronal, metabolic, and gut microbiome systems are
      especially vulnerable by programming from nutritional and maternal factors during this stage
      of life.

      This study will be conducted in Los Angeles. The investigators will recruit
      two-hundred-and-forty mother-infant pairs. Mothers and infants will be monitored during the
      first 36 months of life, with sampling of breast milk (while the mother is still breast
      feeding) and infant and maternal stool at 1, 6, 12, 18, and 24 months of age (or as close as
      possible to each month). Only an infant stool sample will be collected at 36 months of age.
      The main outcomes of this study will be infant body weight-for-length growth during this
      period, as well as body composition (fat and lean mass), which will be measured by skin-fold
      thickness using a caliber, height, weight, and waist circumference measurements at 1, 6, 12,
      18, 24, and 36 months of infant age (or as close as possible to each month). The
      investigators will also assess maternal and infant diet using 24-hour recalls, and maternal
      feeding style and infant eating behaviors using questionnaires.
observational model: Cohort
time perspective: Prospective
measure: Infant weight z-scores at baseline
time frame: Baseline
description: 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.
measure: Infant weight z-scores at 6 months
time frame: 6 months
description: 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.
measure: Infant weight z-scores at 12 months
time frame: 12 months
description: 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.
measure: Infant weight z-scores at 18 months
time frame: 18 months
description: 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.
measure: Infant weight z-scores at 24 months
time frame: 24 months
description: 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.
measure: Infant weight z-scores at 36 months
time frame: 36 months
description: 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.
measure: Infant skinfold thickness at baseline
time frame: Baseline
description: Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
measure: Infant skinfold thickness at 6 months
time frame: 6 months
description: Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
measure: Infant skinfold thickness at 12 months
time frame: 12 months
description: Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
measure: Infant skinfold thickness at 18 months
time frame: 18 months
description: Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
measure: Infant skinfold thickness at 24 months
time frame: 24 months
description: Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
measure: Infant skinfold thickness at 36 months
time frame: 36 months
description: Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
measure: Infant body fat measured using an EchoMRI body composition analyzer at baseline
time frame: Baseline
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
measure: Infant body fat measured using an EchoMRI body composition analyzer at 6 months
time frame: 6 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
measure: Infant body fat measured using an EchoMRI body composition analyzer at 12 months
time frame: 12 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
measure: Infant body fat measured using an EchoMRI body composition analyzer at 18 months
time frame: 18 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
measure: Infant body fat measured using an EchoMRI body composition analyzer at 24 months
time frame: 24 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
measure: Infant lean mass measured using an EchoMRI body composition analyzer at baseline
time frame: Baseline
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
time frame: 6 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 12 months
time frame: 12 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 18 months
time frame: 18 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 24 months
time frame: 24 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
measure: Infant total body water measured using an EchoMRI body composition analyzer at baseline
time frame: Baseline
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
measure: Infant total body water measured using an EchoMRI body composition analyzer at 6 months
time frame: 6 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
measure: Infant total body water measured using an EchoMRI body composition analyzer at 12 months
time frame: 12 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
measure: Infant total body water measured using an EchoMRI body composition analyzer at 18 months
time frame: 18 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
measure: Infant total body water measured using an EchoMRI body composition analyzer at 24 months
time frame: 24 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
measure: Infant free body water measured using an EchoMRI body composition analyzer at baseline
time frame: Baseline
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
measure: Infant free body water measured using an EchoMRI body composition analyzer at 6 months
time frame: 6 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
measure: Infant free body water measured using an EchoMRI body composition analyzer at 12 months
time frame: 12 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
measure: Infant free body water measured using an EchoMRI body composition analyzer at 18 months
time frame: 18 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
measure: Infant free body water measured using an EchoMRI body composition analyzer at 24 months
time frame: 24 months
description: An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
measure: Maternal pregravid BMI
time frame: Baseline
description: Maternal BMI prior to pregnancy will be derived from pregravid BMI (recall during pregnancy at baseline visit) using the equation (weight in kg)/(height in m)^2.
measure: Maternal height at baseline
time frame: Baseline
description: Height (cm) will be measured using a stadiometer.
measure: Maternal height at 6 months
time frame: 6 months
description: Height (cm) will be measured using a stadiometer.
measure: Maternal height at 12 months
time frame: 12 months
description: Height (cm) will be measured using a stadiometer.
measure: Maternal height at 18 months
time frame: 18 months
description: Height (cm) will be measured using a stadiometer.
measure: Maternal height at 24 months
time frame: 24 months
description: Height (cm) will be measured using a stadiometer.
measure: Maternal weight at baseline
time frame: Baseline
description: Weight (kg) will be measured using a portable digital scale.
measure: Maternal weight at 6 months
time frame: 6 months
description: Weight (kg) will be measured using a portable digital scale.
measure: Maternal weight at 12 months
time frame: 12 months
description: Weight (kg) will be measured using a portable digital scale.
measure: Maternal weight at 18 months
time frame: 18 months
description: Weight (kg) will be measured using a portable digital scale.
measure: Maternal weight at 24 months
time frame: 24 months
description: Weight (kg) will be measured using a portable digital scale.
measure: Maternal BMI at baseline
time frame: Baseline
description: Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
measure: Maternal BMI at 6 months
time frame: 6 months
description: Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
measure: Maternal BMI at 12 months
time frame: 12 months
description: Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
measure: Maternal BMI at 18 months
time frame: 18 months
description: Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
measure: Maternal BMI at 24 months
time frame: 24 months
description: Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
measure: Infant length at baseline
time frame: Baseline
description: Infant length (cm) will be measured using an infant measure mat.
measure: Infant length at 6 months
time frame: 6 months
description: Infant length (cm) will be measured using an infant measure mat.
measure: Infant length at 12 months
time frame: 12 months
description: Infant length (cm) will be measured using an infant measure mat.
measure: Infant length at 18 months
time frame: 18 months
description: Infant length (cm) will be measured using an infant measure mat.
measure: Infant length at 24 months
time frame: 24 months
description: Infant length (cm) will be measured using an infant measure mat.
measure: Infant length at 36 months
time frame: 36 months
description: Infant length (cm) will be measured using an infant measure mat.
measure: Infant weight at baseline
time frame: Baseline
description: 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).
measure: Infant weight at 6 months
time frame: 6 months
description: 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).
measure: Infant weight at 12 months
time frame: 12 months
description: 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).
measure: Infant weight at 18 months
time frame: 18 months
description: 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).
measure: Infant weight at 24 months
time frame: 24 months
description: 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).
measure: Infant weight at 36 months
time frame: 36 months
description: 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).
measure: Maternal systolic and diastolic blood pressure at baseline
time frame: Baseline
description: Sitting systolic and diastolic 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).
measure: Maternal systolic and diastolic blood pressure at 6 months
time frame: 6 months
description: Sitting systolic and diastolic 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).
measure: Maternal systolic and diastolic blood pressure at 12 months
time frame: 12 months
description: Sitting systolic and diastolic 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).
measure: Maternal systolic and diastolic blood pressure at 18 months
time frame: 18 months
description: Sitting systolic and diastolic 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).
measure: Maternal systolic and diastolic blood pressure at 24 months
time frame: 24 months
description: Sitting systolic and diastolic 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).
measure: Maternal resting heart rate at baseline
time frame: Baseline
description: 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).
measure: Maternal resting heart rate at 6 months
time frame: 6 months
description: 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).
measure: Maternal resting heart rate at 12 months
time frame: 12 months
description: 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).
measure: Maternal resting heart rate at 18 months
time frame: 18 months
description: 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).
measure: Maternal resting heart rate at 24 months
time frame: 24 months
description: 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).
measure: Maternal diet at baseline
time frame: Baseline
description: 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) which has been used extensively in Hispanic studies.
measure: Maternal diet at 6 months
time frame: 6 months
description: 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) which has been used extensively in Hispanic studies.
measure: Maternal diet at 12 months
time frame: 12 months
description: 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) which has been used extensively in Hispanic studies.
measure: Maternal diet at 18 months
time frame: 18 months
description: 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) which has been used extensively in Hispanic studies.
measure: Maternal diet at 24 months
time frame: 24 months
description: 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) which has been used extensively in Hispanic studies.
measure: Infant diet at baseline
time frame: Baseline
description: 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) which has been used extensively in Hispanic studies.
measure: Infant diet at 6 months
time frame: 6 months
description: 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) which has been used extensively in Hispanic studies.
measure: Infant diet at 12 months
time frame: 12 months
description: 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) which has been used extensively in Hispanic studies.
measure: Infant diet at 18 months
time frame: 18 months
description: 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) which has been used extensively in Hispanic studies.
measure: Infant diet at 24 months
time frame: 24 months
description: 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) which has been used extensively in Hispanic studies.
measure: Infant diet at 36 months
time frame: 36 months
description: 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) which has been used extensively in Hispanic studies.
measure: Maternal beverage recall during last trimester of pregnancy
time frame: Baseline
description: Beverage intake of sugar-sweetened beverages and water will be recalled for a typical week during the last trimester of pregnancy. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.
measure: Maternal beverage recall at baseline
time frame: Baseline
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.
measure: Maternal beverage recall at 6 months
time frame: 6 months
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.
measure: Maternal beverage recall at 12 months
time frame: 12 months
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.
measure: Maternal beverage recall at 18 months
time frame: 18 months
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.
measure: Maternal beverage recall at 24 months
time frame: 24 months
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day.
measure: Infant beverage recall at baseline
time frame: Baseline
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.
measure: Infant beverage recall at 6 months
time frame: 6 months
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.
measure: Infant beverage recall at 12 months
time frame: 12 months
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.
measure: Infant beverage recall at 18 months
time frame: 18 months
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.
measure: Infant beverage recall at 24 months
time frame: 24 months
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.
measure: Infant beverage recall at 36 months
time frame: 36 months
description: Beverage intake of sugar-sweetened beverages and water will be recalled for 1 week. Beverage recalls will indicate how many days each beverage was consumed, and how much was consumed each day. Mothers will be interviewed to report on their infant's beverage intake.
measure: Infant feeding score assessed by Infant Feeding Questionnaire at baseline
time frame: Baseline
description: 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.
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 6 months
time frame: 6 months
description: 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.
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 12 months
time frame: 12 months
description: 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.
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 18 months
time frame: 18 months
description: 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.
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 24 months
time frame: 24 months
description: 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.
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at baseline
time frame: Baseline
description: 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.
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months
time frame: 6 months
description: 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.
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months
time frame: 12 months
description: 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.
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 18 months
time frame: 18 months
description: 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.
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 24 months
time frame: 24 months
description: 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.
measure: Infant behavior score assessed by Infant Behavior Questionnaire at baseline
time frame: Baseline
description: 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.
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 6 months
time frame: 6 months
description: 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.
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 12 months
time frame: 12 months
description: 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.
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 18 months
time frame: 18 months
description: 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.
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 24 months
time frame: 24 months
description: 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.
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at baseline
time frame: Baseline
description: 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.
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months
time frame: 6 months
description: 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.
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 12 months
time frame: 12 months
description: 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.
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 18 months
time frame: 18 months
description: 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.
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 24 months
time frame: 24 months
description: 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.
measure: Infant diet score assessed by Infant Diet Questionnaire at baseline
time frame: Baseline
description: Infant diet will be assessed using a questionnaire which inquires about breastfeeding frequency and duration, formula type/brand/frequency, and consumption of fruit, vegetables, meat, fried foods, juice, and sweetened drinks.
measure: Infant diet score assessed by Infant Diet Questionnaire at 6 months
time frame: 6 months
description: Infant diet will be assessed using a questionnaire which inquires about breastfeeding frequency and duration, formula type/brand/frequency, and consumption of fruit, vegetables, meat, fried foods, juice, and sweetened drinks.
measure: Infant diet score assessed by Infant Diet Questionnaire at 12 months
time frame: 12 months
description: Infant diet will be assessed using a questionnaire which inquires about breastfeeding frequency and duration, formula type/brand/frequency, and consumption of fruit, vegetables, meat, fried foods, juice, and sweetened drinks.
measure: Infant diet score assessed by Infant Diet Questionnaire at 18 months
time frame: 18 months
description: Infant diet will be assessed using a questionnaire which inquires about breastfeeding frequency and duration, formula type/brand/frequency, and consumption of fruit, vegetables, meat, fried foods, juice, and sweetened drinks.
measure: Infant diet score assessed by Infant Diet Questionnaire at 24 months
time frame: 24 months
description: Infant diet will be assessed using a questionnaire which inquires about breastfeeding frequency and duration, formula type/brand/frequency, and consumption of fruit, vegetables, meat, fried foods, juice, and sweetened drinks.
measure: Infant development assessed by the Bayley Scales of Infant and Toddler Development at 24 months
time frame: 24 months
description: Infant development will be assessed using the Bayley Scales of Infant and Toddler Development - Third Edition (BSID-3). This test is designed to assess cognitive, language, motor, social-emotional, and adaptive behavior development in infants and toddlers. This test will be administered and interpreted by trained research personnel. Subscale scores each range from 1 - 19, with higher scores indicating higher performance. Scores from 8 to 12 are considered average.
measure: Infant Magnetic Resonance Imaging (MRI) brain scan at baseline
time frame: Baseline
description: Infant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.
measure: Infant Magnetic Resonance Imaging (MRI) brain scan at 6 months
time frame: 6 months
description: Infant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.
measure: Infant development assessed by the Adaptive Behavior Assessment System at 36 months
time frame: 36 months
description: Infant emotional and adaptive development will be assessed using the Adaptive Behavior Assessment System (ABAS).
measure: Breast milk composition at baseline
time frame: Baseline
description: Breast milk will be collected from mothers at least 1½ 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.
measure: Breast milk composition at 6 months
time frame: 6 months
description: Breast milk will be collected from mothers at least 1½ 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.
measure: Breast milk composition at 12 months
time frame: 12 months
description: Breast milk will be collected from mothers at least 1½ 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.
measure: Breast milk composition at 18 months
time frame: 18 months
description: Breast milk will be collected from mothers at least 1½ 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.
measure: Breast milk composition at 24 months
time frame: 24 months
description: Breast milk will be collected from mothers at least 1½ 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.
measure: Infant gut microbiome at baseline
time frame: Baseline
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
measure: Infant gut microbiome at 6 months
time frame: 6 months
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
measure: Infant gut microbiome at 12 months
time frame: 12 months
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
measure: Infant gut microbiome at 18 months
time frame: 18 months
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
measure: Infant gut microbiome at 24 months
time frame: 24 months
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
measure: Infant gut microbiome at 36 months
time frame: 36 months
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
measure: Maternal gut microbiome at baseline
time frame: Baseline
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
measure: Maternal gut microbiome at 6 months
time frame: 6 months
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
measure: Maternal gut microbiome at 12 months
time frame: 12 months
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
measure: Maternal gut microbiome at 18 months
time frame: 18 months
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
measure: Maternal gut microbiome at 24 months
time frame: 24 months
description: Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Breast milk; Stool (mother and infant)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael I Goran, PhD
role: Principal Investigator
affiliation: University of Southern California; Children's Hospital Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Michael I. Goran
investigator title: Principal Investigator
mesh term: Obesity