Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving the Eating Habits of Mother and Her Infant Via Sugar Reduction (MAMITA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03141346
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Michael I. Goran, University of Southern California

Tracking Information
First Submitted Date  ICMJE May 1, 2017
First Posted Date  ICMJE May 5, 2017
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE September 21, 2017
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Maternal height at baseline [ Time Frame: Baseline ]
    Height (cm) will be measured using a stadiometer.
  • Maternal height at 6 months [ Time Frame: 6 months ]
    Height (cm) will be measured using a stadiometer.
  • Maternal height at 12 months [ Time Frame: 12 months ]
    Height (cm) will be measured using a stadiometer.
  • Maternal height at 24 months [ Time Frame: 24 months ]
    Height (cm) will be measured using a stadiometer.
  • Maternal weight at baseline [ Time Frame: Baseline ]
    Weight (kg) will be measured using a portable digital scale.
  • Maternal weight at 6 months [ Time Frame: 6 months ]
    Weight (kg) will be measured using a portable digital scale.
  • Maternal weight at 12 months [ Time Frame: 12 months ]
    Weight (kg) will be measured using a portable digital scale.
  • Maternal weight at 24 months [ Time Frame: 24 months ]
    Weight (kg) will be measured using a portable digital scale.
  • Maternal BMI at baseline [ Time Frame: Baseline ]
    Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
  • Maternal BMI at 6 months [ Time Frame: 6 months ]
    Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
  • Maternal BMI at 12 months [ Time Frame: 12 months ]
    Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
  • Maternal BMI at 24 months [ Time Frame: 24 months ]
    Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
  • Maternal body fat mass and soft lean tissue mass measured by dual-energy x-ray absorptiometry (DXA) at baseline [ Time Frame: Baseline ]
    Maternal body fat mass and soft lean tissue mass (grams) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal body fat mass and soft lean tissue mass measured by dual-energy x-ray absorptiometry (DXA) at 6 months [ Time Frame: 6 months ]
    Maternal body fat mass and soft lean tissue mass (grams) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal body fat mass and soft lean tissue mass measured by dual-energy x-ray absorptiometry (DXA) at 12 months [ Time Frame: 12 months ]
    Maternal body fat mass and soft lean tissue mass (grams) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal body fat mass and soft lean tissue mass measured by dual-energy x-ray absorptiometry (DXA) at 24 months [ Time Frame: 24 months ]
    Maternal body fat mass and soft lean tissue mass (grams) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal percent body fat measured by dual-energy x-ray absorptiometry (DXA) at baseline [ Time Frame: Baseline ]
    Maternal percent body fat (%) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal percent body fat measured by dual-energy x-ray absorptiometry (DXA) at 6 months [ Time Frame: 6 months ]
    Maternal percent body fat (%) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal percent body fat measured by dual-energy x-ray absorptiometry (DXA) at 12 months [ Time Frame: 12 months ]
    Maternal percent body fat (%) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal percent body fat measured by dual-energy x-ray absorptiometry (DXA) at 24 months [ Time Frame: 24 months ]
    Maternal percent body fat (%) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal bone mineral content measured by dual-energy x-ray absorptiometry (DXA) at baseline [ Time Frame: Baseline ]
    Bone mineral content (BMC) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal bone mineral content measured by dual-energy x-ray absorptiometry (DXA) at 6 months [ Time Frame: 6 months ]
    Bone mineral content (BMC) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal bone mineral content measured by dual-energy x-ray absorptiometry (DXA) at 12 months [ Time Frame: 12 months ]
    Bone mineral content (BMC) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Maternal bone mineral content measured by dual-energy x-ray absorptiometry (DXA) at 24 months [ Time Frame: 24 months ]
    Bone mineral content (BMC) will be measured by dual energy x-ray absorptiometry (DXA) using a Horizon-W densitometer (Hologic, Inc., Bedford, MA).
  • Infant length at baseline [ Time Frame: Baseline ]
    Infant length (cm) will be measured using an infant measure mat.
  • Infant length at 6 months [ Time Frame: 6 months ]
    Infant length (cm) will be measured using an infant measure mat.
  • Infant length at 12 months [ Time Frame: 12 months ]
    Infant length (cm) will be measured using an infant measure mat.
  • Infant length at 24 months [ Time Frame: 24 months ]
    Infant length (cm) will be measured using an infant measure mat.
  • Infant weight at baseline [ Time Frame: 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).
  • Infant weight at 6 months [ Time Frame: 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).
  • Infant weight at 12 months [ Time Frame: 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).
  • Infant weight at 24 months [ Time Frame: 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).
  • 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 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 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 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 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 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 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • Maternal BMI [ Time Frame: 24 months ]
    Change in maternal BMI
  • Infant weight-for-length [ Time Frame: 24 months ]
    Change in infant weight-for-length
Change History Complete list of historical versions of study NCT03141346 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Maternal blood glucose at baseline [ Time Frame: Baseline ]
    A fasting blood draw will be taken from mothers in the study to measure glucose levels in the blood.
  • Maternal blood glucose at 6 months [ Time Frame: 6 months ]
    A fasting blood draw will be taken from mothers in the study to measure glucose levels in the blood.
  • Maternal blood glucose at 12 months [ Time Frame: 12 months ]
    A fasting blood draw will be taken from mothers in the study to measure glucose levels in the blood.
  • Maternal blood glucose at 24 months [ Time Frame: 24 months ]
    A fasting blood draw will be taken from mothers in the study to measure glucose levels in the blood.
  • Maternal insulin at baseline [ Time Frame: Baseline ]
    A fasting blood draw will be taken from mothers in the study to measure insulin levels in the blood.
  • Maternal insulin at 6 months [ Time Frame: 6 months ]
    A fasting blood draw will be taken from mothers in the study to measure insulin levels in the blood.
  • Maternal insulin at 12 months [ Time Frame: 12 months ]
    A fasting blood draw will be taken from mothers in the study to measure insulin levels in the blood.
  • Maternal insulin at 24 months [ Time Frame: 24 months ]
    A fasting blood draw will be taken from mothers in the study to measure insulin levels in the blood.
  • Maternal adipokine and hormone concentration in the blood at baseline [ Time Frame: Baseline ]
    A fasting blood draw will be taken from mothers in the study to measure the concentration of a panel of adipokines and hormones in the blood: C-reactive protein, leptin, resistin, adiponectin, IL-6, TNF-alpha, MCP-1, and PAI-1.
  • Maternal adipokine and hormone concentration in the blood at 6 months [ Time Frame: 6 months ]
    A fasting blood draw will be taken from mothers in the study to measure the concentration of a panel of adipokines and hormones in the blood: C-reactive protein, leptin, resistin, adiponectin, IL-6, TNF-alpha, MCP-1, and PAI-1.
  • Maternal adipokine and hormone concentration in the blood at 12 months [ Time Frame: 12 months ]
    A fasting blood draw will be taken from mothers in the study to measure the concentration of a panel of adipokines and hormones in the blood: C-reactive protein, leptin, resistin, adiponectin, IL-6, TNF-alpha, MCP-1, and PAI-1.
  • Maternal adipokine and hormone concentration in the blood at 24 months [ Time Frame: 24 months ]
    A fasting blood draw will be taken from mothers in the study to measure the concentration of a panel of adipokines and hormones in the blood: C-reactive protein, leptin, resistin, adiponectin, IL-6, TNF-alpha, MCP-1, and PAI-1.
  • Maternal lipids at baseline [ Time Frame: Baseline ]
    A fasting blood draw will be taken from mothers in the study to measure lipid levels in the blood.
  • Maternal lipids at 6 months [ Time Frame: 6 months ]
    A fasting blood draw will be taken from mothers in the study to measure lipid levels in the blood.
  • Maternal lipids at 12 months [ Time Frame: 12 months ]
    A fasting blood draw will be taken from mothers in the study to measure lipid levels in the blood.
  • Maternal lipids at 24 months [ Time Frame: 24 months ]
    A fasting blood draw will be taken from mothers in the study to measure lipid levels in the blood.
  • Maternal pregravid BMI [ Time Frame: Baseline ]
    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.
  • Maternal blood pressure at baseline [ Time Frame: 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).
  • Maternal blood pressure at 6 months [ Time Frame: 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).
  • Maternal blood pressure at 12 months [ Time Frame: 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).
  • Maternal blood pressure at 24 months [ Time Frame: 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).
  • Maternal resting heart rate at baseline [ Time Frame: 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).
  • Maternal resting heart rate at 6 months [ Time Frame: 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).
  • Maternal resting heart rate at 12 months [ Time Frame: 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).
  • Maternal resting heart rate at 24 months [ Time Frame: 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).
  • Maternal diet at baseline [ Time Frame: 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.
  • Maternal diet at 6 months [ Time Frame: 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.
  • Maternal diet at 12 months [ Time Frame: 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.
  • Maternal diet at 24 months [ Time Frame: 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.
  • Infant diet at 6 months [ Time Frame: 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.
  • Infant diet at 12 months [ Time Frame: 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.
  • Infant diet at 24 months [ Time Frame: 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.
  • Infant feeding score assessed by Infant Feeding Questionnaire at baseline [ Time Frame: 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.
  • Infant feeding score assessed by Infant Feeding Questionnaire at 6 months [ Time Frame: 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.
  • Infant feeding score assessed by Infant Feeding Questionnaire at 12 months [ Time Frame: 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.
  • Infant feeding score assessed by Infant Feeding Questionnaire at 24 months [ Time Frame: 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.
  • Infant feeding style score assessed by Infant Feeding Style Questionnaire at baseline [ Time Frame: 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.
  • Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months [ Time Frame: 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.
  • Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months [ Time Frame: 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.
  • Infant feeding style score assessed by Infant Feeding Style Questionnaire at 24 months [ Time Frame: 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.
  • Infant behavior score assessed by Infant Behavior Questionnaire at baseline [ Time Frame: 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.
  • Infant behavior score assessed by Infant Behavior Questionnaire at 6 months [ Time Frame: 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.
  • Infant behavior score assessed by Early Child Behavior Questionnaire at 12 months [ Time Frame: 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.
  • Infant behavior score assessed by Early Child Behavior Questionnaire at 24 months [ Time Frame: 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.
  • Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at baseline [ Time Frame: 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.
  • Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months [ Time Frame: 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.
  • Infant eating behavior score assessed by Child Eating Behavior Questionnaire at 12 months [ Time Frame: 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.
  • Infant eating behavior score assessed by Child Eating Behavior Questionnaire at 24 months [ Time Frame: 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.
  • Breast milk composition at baseline [ Time Frame: 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.
  • Breast milk composition at 6 months [ Time Frame: 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.
  • Breast milk composition at 12 months [ Time Frame: 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.
  • Breast milk composition at 24 months [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving the Eating Habits of Mother and Her Infant Via Sugar Reduction
Official Title  ICMJE Home Intervention for Reducing Sugary Drinks and Obesity in Hispanic Women-infants
Brief Summary The purpose of this study is to determine whether a home visitation 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 home visitation program only; Group 2 (translation): home visitation program focused on sugar reduction; and Group 3 (efficacy): home visitation program focused on sugar reduction and bottled water delivery.
Detailed Description

This study will determine whether a home visitation 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 home visitation program only; group 2, a home visitation program that incorporates sugar reduction; and group 3, a home visitation program that incorporates sugar reduction with home bottled water delivery. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: Sugar reduction home visitation program
    A home visitation program incorporating sugar reduction education and monitoring provided by a trained health educator over 24 months
  • Behavioral: Control home visitation program
    Control home visitation program provided by a trained health educator over 24 months
  • Other: Home water delivery
    Home delivery of bottled water administered over 24 months
Study Arms  ICMJE
  • Active Comparator: Control
    A control home visitation program to promote general health and safety
    Intervention: Behavioral: Control home visitation program
  • Experimental: Sugar Reduction Program Only
    A home visitation program that focuses on sugar reduction
    Intervention: Behavioral: Sugar reduction home visitation program
  • Experimental: Sugar Reduction Program & Water Delivery
    A home visitation program that focuses on sugar reduction and provides home bottled water delivery
    Interventions:
    • Behavioral: Sugar reduction home visitation program
    • Other: Home water delivery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2017)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • Mothers who are habitual consumers of sugar sweetened beverages and juices

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michael I Goran 323-361-8571 goran@usc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03141346
Other Study ID Numbers  ICMJE CHLA-18-00571
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael I. Goran, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Children's Hospital Los Angeles
Investigators  ICMJE
Principal Investigator: Michael I Goran University of Southern California; Children's Hospital Los Angeles
PRS Account University of Southern California
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP