The purpose of this study is to determine whether a health education program incorporating sugar sweetened beverage and juice (SSB/J) reduction and home water delivery affects maternal and infant risk for obesity by randomizing mother-infant dyads to one of three 24-month interventions: Group 1 (control): standard health education program only; Group 2 (translation): health education program focused on sugar reduction; and Group 3 (efficacy): health education program focused on sugar reduction and bottled water delivery. The intervention program will be delivered by trained health educators during in-person home visits, or virtually via phone or video calls.
This study will determine whether a health education program incorporating sugar sweetened beverage and juice (SSB/J) reduction and home water delivery affects maternal and infant risk for obesity. The postpartum period is a time of both opportunity and vulnerability for mothers and their infants to diminish risk for obesity and related health problems. This is particularly relevant in the context of Hispanic families. Hispanic mothers are at high-risk for excess gestational weight gain and postpartum weight retention, and their infants are at high-risk for rapid weight gain associated with early onset obesity. A contributing factor may be their intake of SSB/J. There is a high prevalence of reported SSB/J consumption in low-income Hispanic households, and Hispanic mothers are more likely to incorporate sweet foods during weaning. Because evidence suggests that obese Hispanic children are responsive to SSB/J reduction and substitution with non-caloric beverages, this may be a potential strategy for Hispanic mothers that may also be beneficial for their infants. This study will be conducted in Los Angeles. Two-hundred-and-forty Hispanic mothers and their infants will be recruited. They will be randomly assigned to: group 1, a standard health education program only; group 2, a health education program that incorporates sugar reduction; and group 3, a health education program that incorporates sugar reduction with home bottled water delivery. The intervention program will be delivered by trained health educators during in-person home visits, or virtually via phone or video calls. The main outcomes are maternal weight status and infant weight change. We will also assess maternal and infant diet using 24-hour recalls, and maternal feeding style and infant eating behaviors using questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
211
A health education program incorporating sugar reduction education and monitoring provided by a trained health educator over 24 months. The intervention program will be delivered by the health educator during in-person home visits, or virtually via phone or video calls.
Control health education program provided by a trained health educator over 24 months. The intervention program will be delivered by the health educator during in-person home visits, or virtually via phone or video calls.
Home delivery of bottled water administered over 24 months
Children's Hospital Los Angeles
Los Angeles, California, United States
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 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 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 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 24 months
Infant length (cm) will be measured using an infant measure mat.
Time frame: 24 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 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 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 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.
Time frame: 24 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 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.
Time frame: 24 months
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 blood pressure at baseline
Sitting blood pressure will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Time frame: Baseline
Maternal blood pressure at 6 months
Sitting blood pressure will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Time frame: 6 months
Maternal blood pressure at 12 months
Sitting blood pressure will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Time frame: 12 months
Maternal blood pressure at 24 months
Sitting blood pressure will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
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
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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 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 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 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, starting at the 6-month visit when infants are likely to be introduced to solid foods. 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, starting at the 6-month visit when infants are likely to be introduced to solid foods. 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 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, starting at the 6-month visit when infants are likely to be introduced to solid foods. 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 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 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; and 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 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 Early Child Behavior Questionnaire at 12 months
Infant behavior score will be assessed using the Rothbart Early Child 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: negative affectivity; surgency-extroversion; and effortful control.
Time frame: 12 months
Infant behavior score assessed by Early Child Behavior Questionnaire at 24 months
Infant behavior score will be assessed using the Rothbart Early Child 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: negative affectivity; surgency-extroversion; and effortful control.
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 Child Eating Behavior Questionnaire at 12 months
Infant eating behavior score will be assessed using the Wardle Child 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; enjoyment of food; emotional overeating; desire to drink; satiety responsiveness; slowness in eating; emotional undereating; and fussiness.
Time frame: 12 months
Infant eating behavior score assessed by Child Eating Behavior Questionnaire at 24 months
Infant eating behavior score will be assessed using the Wardle Child 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; enjoyment of food; emotional overeating; desire to drink; satiety responsiveness; slowness in eating; emotional undereating; and fussiness.
Time frame: 24 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 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