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

Obesity Clinical Trial

— MAMITA  

Official title:

Home Intervention for Reducing Sugary Drinks and Obesity in Hispanic Women-infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03141346
• Other study ID #: CHLA-18-00571
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 211
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Sugar reduction health education program
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
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.

Other:
• Home water delivery
Home delivery of bottled water administered over 24 months

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal height at baseline	Height (cm) will be measured using a stadiometer.	Baseline
Primary	Maternal height at 6 months	Height (cm) will be measured using a stadiometer.	6 months
Primary	Maternal height at 12 months	Height (cm) will be measured using a stadiometer.	12 months
Primary	Maternal height at 24 months	Height (cm) will be measured using a stadiometer.	24 months
Primary	Maternal weight at baseline	Weight (kg) will be measured using a portable digital scale.	Baseline
Primary	Maternal weight at 6 months	Weight (kg) will be measured using a portable digital scale.	6 months
Primary	Maternal weight at 12 months	Weight (kg) will be measured using a portable digital scale.	12 months
Primary	Maternal weight at 24 months	Weight (kg) will be measured using a portable digital scale.	24 months
Primary	Maternal BMI at baseline	Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.	Baseline
Primary	Maternal BMI at 6 months	Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.	6 months
Primary	Maternal BMI at 12 months	Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.	12 months
Primary	Maternal BMI at 24 months	Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.	24 months
Primary	Infant length at baseline	Infant length (cm) will be measured using an infant measure mat.	Baseline
Primary	Infant length at 6 months	Infant length (cm) will be measured using an infant measure mat.	6 months
Primary	Infant length at 12 months	Infant length (cm) will be measured using an infant measure mat.	12 months
Primary	Infant length at 24 months	Infant length (cm) will be measured using an infant measure mat.	24 months
Primary	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).	Baseline
Primary	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).	6 months
Primary	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).	12 months
Primary	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).	24 months
Primary	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.	Baseline
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	24 months
Primary	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.	Baseline
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	24 months
Primary	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.	Baseline
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	24 months
Primary	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.	Baseline
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	24 months
Primary	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.	Baseline
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	24 months
Secondary	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.	Baseline
Secondary	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).	Baseline
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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).	24 months
Secondary	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).	Baseline
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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).	24 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	24 months