NCT04434027 - The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development | Crick

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.

Time frame: Baseline

Maternal height at baseline

Height (cm) will be measured using a stadiometer.

Time frame: Baseline

Maternal height at 6 months

Height (cm) will be measured using a stadiometer.

Time frame: 6 months

Maternal height at 12 months

Height (cm) will be measured using a stadiometer.

Time frame: 12 months

Maternal height at 18 months

Height (cm) will be measured using a stadiometer.

Time frame: 18 months

Maternal height at 24 months

Height (cm) will be measured using a stadiometer.

Time frame: 24 months

Maternal weight at baseline

Weight (kg) will be measured using a portable digital scale.

Time frame: Baseline

Maternal weight at 6 months

Weight (kg) will be measured using a portable digital scale.

Time frame: 6 months

Maternal weight at 12 months

Weight (kg) will be measured using a portable digital scale.

Time frame: 12 months

Maternal weight at 18 months

Weight (kg) will be measured using a portable digital scale.

Time frame: 18 months

Maternal weight at 24 months

Weight (kg) will be measured using a portable digital scale.

Time frame: 24 months

Maternal BMI at baseline

Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.

Time frame: Baseline

Maternal BMI at 6 months

Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 24 months

Infant length at baseline

Infant length (cm) will be measured using an infant measure mat.

Time frame: Baseline

Infant length at 6 months

Infant length (cm) will be measured using an infant measure mat.

Time frame: 6 months

Infant length at 12 months

Infant length (cm) will be measured using an infant measure mat.

Time frame: 12 months

Infant length at 18 months

Infant length (cm) will be measured using an infant measure mat.

Time frame: 18 months

Infant length at 24 months

Infant length (cm) will be measured using an infant measure mat.

Time frame: 24 months

Infant length at 36 months

Infant length (cm) will be measured using an infant measure mat.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 24 months

Infant gut microbiome at baseline