ObesityNCT04434027
The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development
An observational study of Obesity, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Normal, overweight or obese (>25 BMI kg/m2) non-diabetic Hispanic mothers (18-59yrs) and their infants (<1-36 months) from Los Angeles, CA.
Who may be able to join
- Mothers who self-identify as Hispanic
- Mothers who have or have had singleton births
- Mothers will be recruited prior to their infant's birth or up to 1-month postpartum
- Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level
Who cannot join
- Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers
- Physical, mental, or cognitive issues that prevent participation
- Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles
- Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs
- Clinical diagnosis of gestational diabetes
- Pre-term/low birth weight infants, or diagnosis of any fetal abnormalities
- Mothers less than 18 years of age at the time of delivery will not be eligible as to avoid potential confounding from those subjects who might still be completing adolescent growth
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Mother's Milk Study: Determining the Impact of Human Milk Oligosaccharides (HMOs) on Healthy Infant Growth and Development
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.
Read the detailed description
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.
- Conditions
- Obesity
- Keywords
- microbiome, nutrition, obesity, growth, breastfeeding, mother, infant, cognitive development
- Medical subject headings
- Obesity, Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant weight z-scores at baseline
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Measured: Baseline
Infant weight z-scores at 6 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Measured: 6 months
Infant weight z-scores at 12 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Measured: 12 months
Infant weight z-scores at 18 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Measured: 18 months
Infant weight z-scores at 24 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Measured: 24 months
Infant weight z-scores at 36 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Measured: 36 months
Infant skinfold thickness at baseline
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Measured: Baseline
Infant skinfold thickness at 6 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Measured: 6 months
Infant skinfold thickness at 12 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Measured: 12 months
Infant skinfold thickness at 18 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Measured: 18 months
Infant skinfold thickness at 24 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Measured: 24 months
Infant skinfold thickness at 36 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Measured: 36 months
Infant body fat measured using an EchoMRI body composition analyzer at baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Measured: Baseline
Infant body fat measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Measured: 6 months
Infant body fat measured using an EchoMRI body composition analyzer at 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Measured: 12 months
Infant body fat measured using an EchoMRI body composition analyzer at 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Measured: 18 months
Infant body fat measured using an EchoMRI body composition analyzer at 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Measured: 24 months
Infant lean mass measured using an EchoMRI body composition analyzer at baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: Baseline
Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: 6 months
Infant lean mass measured using an EchoMRI body composition analyzer at 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: 12 months
Infant lean mass measured using an EchoMRI body composition analyzer at 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: 18 months
Infant lean mass measured using an EchoMRI body composition analyzer at 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: 24 months
Infant total body water measured using an EchoMRI body composition analyzer at baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Measured: Baseline
Infant total body water measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Measured: 6 months
Infant total body water measured using an EchoMRI body composition analyzer at 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Measured: 12 months
Infant total body water measured using an EchoMRI body composition analyzer at 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Measured: 18 months
Infant total body water measured using an EchoMRI body composition analyzer at 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Measured: 24 months
Infant free body water measured using an EchoMRI body composition analyzer at baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Measured: Baseline
Infant free body water measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Measured: 6 months
Infant free body water measured using an EchoMRI body composition analyzer at 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Measured: 12 months
Infant free body water measured using an EchoMRI body composition analyzer at 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Measured: 18 months
Infant free body water measured using an EchoMRI body composition analyzer at 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Measured: 24 months
Secondary outcomes (106)
Maternal pregravid BMI
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.
Measured: Baseline
Maternal height at baseline
Height (cm) will be measured using a stadiometer.
Measured: Baseline
Maternal height at 6 months
Height (cm) will be measured using a stadiometer.
Measured: 6 months
Maternal height at 12 months
Height (cm) will be measured using a stadiometer.
Measured: 12 months
Maternal height at 18 months
Height (cm) will be measured using a stadiometer.
Measured: 18 months
Maternal height at 24 months
Height (cm) will be measured using a stadiometer.
Measured: 24 months
Maternal weight at baseline
Weight (kg) will be measured using a portable digital scale.
Measured: Baseline
Maternal weight at 6 months
Weight (kg) will be measured using a portable digital scale.
Measured: 6 months
Maternal weight at 12 months
Weight (kg) will be measured using a portable digital scale.
Measured: 12 months
Maternal weight at 18 months
Weight (kg) will be measured using a portable digital scale.
Measured: 18 months
Maternal weight at 24 months
Weight (kg) will be measured using a portable digital scale.
Measured: 24 months
Maternal BMI at baseline
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
Measured: Baseline
Maternal BMI at 6 months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
Measured: 6 months
Maternal BMI at 12 months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
Measured: 12 months
Maternal BMI at 18 months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
Measured: 18 months
Maternal BMI at 24 months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
Measured: 24 months
Infant length at baseline
Infant length (cm) will be measured using an infant measure mat.
Measured: Baseline
Infant length at 6 months
Infant length (cm) will be measured using an infant measure mat.
Measured: 6 months
Infant length at 12 months
Infant length (cm) will be measured using an infant measure mat.
Measured: 12 months
Infant length at 18 months
Infant length (cm) will be measured using an infant measure mat.
Measured: 18 months
Infant length at 24 months
Infant length (cm) will be measured using an infant measure mat.
Measured: 24 months
Infant length at 36 months
Infant length (cm) will be measured using an infant measure mat.
Measured: 36 months
Infant weight at baseline
Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
Measured: Baseline
Infant weight at 6 months
Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
Measured: 6 months
Infant weight at 12 months
Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
Measured: 12 months
Infant weight at 18 months
Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
Measured: 18 months
Infant weight at 24 months
Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
Measured: 24 months
Infant weight at 36 months
Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
Measured: 36 months
Maternal systolic and diastolic blood pressure at baseline
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).
Measured: Baseline
Maternal systolic and diastolic blood pressure at 6 months
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).
Measured: 6 months
Maternal systolic and diastolic blood pressure at 12 months
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).
Measured: 12 months
Maternal systolic and diastolic blood pressure at 18 months
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).
Measured: 18 months
Maternal systolic and diastolic blood pressure at 24 months
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).
Measured: 24 months
Maternal resting heart rate at baseline
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Measured: Baseline
Maternal resting heart rate at 6 months
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Measured: 6 months
Maternal resting heart rate at 12 months
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Measured: 12 months
Maternal resting heart rate at 18 months
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Measured: 18 months
Maternal resting heart rate at 24 months
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Measured: 24 months
Maternal diet at baseline
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.
Measured: Baseline
Maternal diet at 6 months
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 6 months
Maternal diet at 12 months
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 12 months
Maternal diet at 18 months
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 18 months
Maternal diet at 24 months
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 24 months
Infant diet at baseline
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.
Measured: Baseline
Infant diet at 6 months
24-hour diet recalls will be conducted for one week day and one weekend day. Mothers will be interviewed to report on their infant's food intake. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 6 months
Infant diet at 12 months
24-hour diet recalls will be conducted for one week day and one weekend day. Mothers will be interviewed to report on their infant's food intake. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 12 months
Infant diet at 18 months
24-hour diet recalls will be conducted for one week day and one weekend day. Mothers will be interviewed to report on their infant's food intake. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 18 months
Infant diet at 24 months
24-hour diet recalls will be conducted for one week day and one weekend day. Mothers will be interviewed to report on their infant's food intake. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 24 months
Infant diet at 36 months
24-hour diet recalls will be conducted for one week day and one weekend day. Mothers will be interviewed to report on their infant's food intake. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 36 months
Maternal beverage recall during last trimester of pregnancy
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.
Measured: Baseline
Maternal beverage recall at baseline
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.
Measured: Baseline
Maternal beverage recall at 6 months
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.
Measured: 6 months
Maternal beverage recall at 12 months
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.
Measured: 12 months
Maternal beverage recall at 18 months
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.
Measured: 18 months
Maternal beverage recall at 24 months
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.
Measured: 24 months
Infant beverage recall at baseline
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.
Measured: Baseline
Infant beverage recall at 6 months
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.
Measured: 6 months
Infant beverage recall at 12 months
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.
Measured: 12 months
Infant beverage recall at 18 months
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.
Measured: 18 months
Infant beverage recall at 24 months
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.
Measured: 24 months
Infant beverage recall at 36 months
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.
Measured: 36 months
Infant feeding score assessed by Infant Feeding Questionnaire at baseline
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Measured: Baseline
Infant feeding score assessed by Infant Feeding Questionnaire at 6 months
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Measured: 6 months
Infant feeding score assessed by Infant Feeding Questionnaire at 12 months
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Measured: 12 months
Infant feeding score assessed by Infant Feeding Questionnaire at 18 months
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Measured: 18 months
Infant feeding score assessed by Infant Feeding Questionnaire at 24 months
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Measured: 24 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at baseline
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: Baseline
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: 6 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: 12 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 18 months
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: 18 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 24 months
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: 24 months
Infant behavior score assessed by Infant Behavior Questionnaire at baseline
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Measured: Baseline
Infant behavior score assessed by Infant Behavior Questionnaire at 6 months
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Measured: 6 months
Infant behavior score assessed by Infant Behavior Questionnaire at 12 months
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Measured: 12 months
Infant behavior score assessed by Infant Behavior Questionnaire at 18 months
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Measured: 18 months
Infant behavior score assessed by Infant Behavior Questionnaire at 24 months
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Measured: 24 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at baseline
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Measured: Baseline
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Measured: 6 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 12 months
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Measured: 12 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 18 months
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Measured: 18 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 24 months
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Measured: 24 months
Infant diet score assessed by Infant Diet Questionnaire at baseline
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.
Measured: Baseline
Infant diet score assessed by Infant Diet Questionnaire at 6 months
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.
Measured: 6 months
Infant diet score assessed by Infant Diet Questionnaire at 12 months
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.
Measured: 12 months
Infant diet score assessed by Infant Diet Questionnaire at 18 months
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.
Measured: 18 months
Infant diet score assessed by Infant Diet Questionnaire at 24 months
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.
Measured: 24 months
Infant development assessed by the Bayley Scales of Infant and Toddler Development at 24 months
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.
Measured: 24 months
Infant Magnetic Resonance Imaging (MRI) brain scan at baseline
Infant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.
Measured: Baseline
Infant Magnetic Resonance Imaging (MRI) brain scan at 6 months
Infant brain will be scanned using Magnetic Resonance Imaging (MRI) to measure structure and function.
Measured: 6 months
Infant development assessed by the Adaptive Behavior Assessment System at 36 months
Infant emotional and adaptive development will be assessed using the Adaptive Behavior Assessment System (ABAS).
Measured: 36 months
Breast milk composition at baseline
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.
Measured: Baseline
Breast milk composition at 6 months
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.
Measured: 6 months
Breast milk composition at 12 months
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.
Measured: 12 months
Breast milk composition at 18 months
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.
Measured: 18 months
Breast milk composition at 24 months
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.
Measured: 24 months
Infant gut microbiome at baseline
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: Baseline
Infant gut microbiome at 6 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 6 months
Infant gut microbiome at 12 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 12 months
Infant gut microbiome at 18 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 18 months
Infant gut microbiome at 24 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 24 months
Infant gut microbiome at 36 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 36 months
Maternal gut microbiome at baseline
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: Baseline
Maternal gut microbiome at 6 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 6 months
Maternal gut microbiome at 12 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 12 months
Maternal gut microbiome at 18 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 18 months
Maternal gut microbiome at 24 months
Stool samples will be collected in OmniGUT gene kits and aliquoted to be stored at -80oC. Gut microbes will be analyzed using 16S sequencing.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study startJul 2016
- Primary completionAug 2022
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael I. Goran, University of Southern California
- Investigators
- Michael I Goran, PhD, Principal investigator, University of Southern California; Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434027
- Sponsor's protocol ID
- CHLA-18-00576
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother's Milk Study: Determining the Impact of Human Milk Oligosaccharides (HMOs) on Healthy Infant Growth and Development
- ClinicalTrials.gov ID
- NCT04434027
- Acronym / sponsor ID
- CHLA-18-00576
- Conditions
- Obesity
- Keywords
- microbiome, nutrition, obesity, growth, breastfeeding, mother, infant, cognitive development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles, University of California, San Diego
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normal, overweight or obese (>25 BMI kg/m2) non-diabetic Hispanic mothers (18-59yrs) and their infants (<1-36 months) from Los Angeles, CA.
Key inclusion criteria (4 listed)
- Mothers who self-identify as Hispanic
- Mothers who have or have had singleton births
- Mothers will be recruited prior to their infant's birth or up to 1-month postpartum
- Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level
Key exclusion criteria (7 listed)
- Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers
- Physical, mental, or cognitive issues that prevent participation
- Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles
- Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs
- Clinical diagnosis of gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infant weight z-scores at baseline
Time frame: Baseline
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Infant weight z-scores at 6 months
Time frame: 6 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Infant weight z-scores at 12 months
Time frame: 12 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Infant weight z-scores at 18 months
Time frame: 18 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Infant weight z-scores at 24 months
Time frame: 24 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Infant weight z-scores at 36 months
Time frame: 36 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Infant skinfold thickness at baseline
Time frame: Baseline
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant skinfold thickness at 6 months
Time frame: 6 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant skinfold thickness at 12 months
Time frame: 12 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant skinfold thickness at 18 months
Time frame: 18 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant skinfold thickness at 24 months
Time frame: 24 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant skinfold thickness at 36 months
Time frame: 36 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant body fat measured using an EchoMRI body composition analyzer at baseline
Time frame: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant body fat measured using an EchoMRI body composition analyzer at 6 months
Time frame: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant body fat measured using an EchoMRI body composition analyzer at 12 months
Time frame: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant body fat measured using an EchoMRI body composition analyzer at 18 months
Time frame: 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant body fat measured using an EchoMRI body composition analyzer at 24 months
Time frame: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at baseline
Time frame: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
Time frame: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 12 months
Time frame: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 18 months
Time frame: 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 24 months
Time frame: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant total body water measured using an EchoMRI body composition analyzer at baseline
Time frame: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 6 months
Time frame: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 12 months
Time frame: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 18 months
Time frame: 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 24 months
Time frame: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at baseline
Time frame: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 6 months
Time frame: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 12 months
Time frame: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 18 months
Time frame: 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 24 months
Time frame: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
106 secondary outcomes
Maternal pregravid BMI
Time frame: Baseline
Maternal height at baseline
Time frame: Baseline
Maternal height at 6 months
Time frame: 6 months
Maternal height at 12 months
Time frame: 12 months
Maternal height at 18 months
Time frame: 18 months
Maternal height at 24 months
Time frame: 24 months
Maternal weight at baseline
Time frame: Baseline
Maternal weight at 6 months
Time frame: 6 months
Maternal weight at 12 months
Time frame: 12 months
Maternal weight at 18 months
Time frame: 18 months
Maternal weight at 24 months
Time frame: 24 months
Maternal BMI at baseline
Time frame: Baseline
Maternal BMI at 6 months
Time frame: 6 months
Maternal BMI at 12 months
Time frame: 12 months
Maternal BMI at 18 months
Time frame: 18 months
Maternal BMI at 24 months
Time frame: 24 months
Infant length at baseline
Time frame: Baseline
Infant length at 6 months
Time frame: 6 months
Infant length at 12 months
Time frame: 12 months
Infant length at 18 months
Time frame: 18 months
Infant length at 24 months
Time frame: 24 months
Infant length at 36 months
Time frame: 36 months
Infant weight at baseline
Time frame: Baseline
Infant weight at 6 months
Time frame: 6 months
Infant weight at 12 months
Time frame: 12 months
Infant weight at 18 months
Time frame: 18 months
Infant weight at 24 months
Time frame: 24 months
Infant weight at 36 months
Time frame: 36 months
Maternal systolic and diastolic blood pressure at baseline
Time frame: Baseline
Maternal systolic and diastolic blood pressure at 6 months
Time frame: 6 months
Maternal systolic and diastolic blood pressure at 12 months
Time frame: 12 months
Maternal systolic and diastolic blood pressure at 18 months
Time frame: 18 months
Maternal systolic and diastolic blood pressure at 24 months
Time frame: 24 months
Maternal resting heart rate at baseline
Time frame: Baseline
Maternal resting heart rate at 6 months
Time frame: 6 months
Maternal resting heart rate at 12 months
Time frame: 12 months
Maternal resting heart rate at 18 months
Time frame: 18 months
Maternal resting heart rate at 24 months
Time frame: 24 months
Maternal diet at baseline
Time frame: Baseline
Maternal diet at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael I Goran, PhD principal investigator
University of Southern California; Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant weight z-scores at baseline (time frame: Baseline). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.