ObesityMAMITANCT03141346
Improving the Eating Habits of Mother and Her Infant Via Sugar Reduction
A study testing Sugar reduction health education program and Home water delivery in people with Obesity, run by Children's Hospital Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Sugar reduction health education program and Home water delivery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 21 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mothers who self-identify as Hispanic
- Mothers who have or have had singleton births
- Mothers will be recruited prior to their infant's birth or up to 1-month postpartum
- Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level
- Mothers who are habitual consumers of sugar sweetened beverages and juices
Who cannot join
- Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers
- Physical, mental, or cognitive issues that prevent participation
- Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles
- Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs
- Clinical diagnosis of gestational diabetes
- Pre-term/low birth weight infants, or diagnosis of any fetal abnormalities
- Mothers less than 18 years of age at the time of delivery will not be eligible as to avoid potential confounding from those subjects who might still be completing adolescent growth
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Home Intervention for Reducing Sugary Drinks and Obesity in Hispanic Women-infants
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.
Read the detailed 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.
- Conditions
- Obesity
- Being tested
- Sugar reduction health education program, Control health education program, Home water delivery
- Keywords
- mother, infant, nutrition, sugar, obesity, growth
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar reduction health education programBehavioural
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 programBehavioural
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 water deliveryOther
Home delivery of bottled water administered over 24 months
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | A control health education program to promote general health and safety Receives: Behavioral: Control health education program |
| Sugar Reduction Program Only | Experimental | A health education program that focuses on sugar reduction Receives: Behavioral: Sugar reduction health education program |
| Sugar Reduction Program & Water Delivery | Experimental | A health education program that focuses on sugar reduction and provides home bottled water delivery Receives: Behavioral: Sugar reduction health education program; Other: Home water delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal height at baseline
Height (cm) will be measured using a stadiometer.
Measured: Baseline
Maternal height at 6 months
Height (cm) will be measured using a stadiometer.
Measured: 6 months
Maternal height at 12 months
Height (cm) will be measured using a stadiometer.
Measured: 12 months
Maternal height at 24 months
Height (cm) will be measured using a stadiometer.
Measured: 24 months
Maternal weight at baseline
Weight (kg) will be measured using a portable digital scale.
Measured: Baseline
Maternal weight at 6 months
Weight (kg) will be measured using a portable digital scale.
Measured: 6 months
Maternal weight at 12 months
Weight (kg) will be measured using a portable digital scale.
Measured: 12 months
Maternal weight at 24 months
Weight (kg) will be measured using a portable digital scale.
Measured: 24 months
Maternal BMI at baseline
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
Measured: Baseline
Maternal BMI at 6 months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
Measured: 6 months
Maternal BMI at 12 months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
Measured: 12 months
Maternal BMI at 24 months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)^2.
Measured: 24 months
Infant length at baseline
Infant length (cm) will be measured using an infant measure mat.
Measured: Baseline
Infant length at 6 months
Infant length (cm) will be measured using an infant measure mat.
Measured: 6 months
Infant length at 12 months
Infant length (cm) will be measured using an infant measure mat.
Measured: 12 months
Infant length at 24 months
Infant length (cm) will be measured using an infant measure mat.
Measured: 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).
Measured: Baseline
Infant weight at 6 months
Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
Measured: 6 months
Infant weight at 12 months
Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
Measured: 12 months
Infant weight at 24 months
Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).
Measured: 24 months
Infant weight z-scores at baseline
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Measured: Baseline
Infant weight z-scores at 6 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Measured: 6 months
Infant weight z-scores at 12 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Measured: 12 months
Infant weight z-scores at 24 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children <24 mos.
Measured: 24 months
Infant body fat measured using an EchoMRI body composition analyzer at baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Measured: Baseline
Infant body fat measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Measured: 6 months
Infant body fat measured using an EchoMRI body composition analyzer at 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Measured: 12 months
Infant body fat measured using an EchoMRI body composition analyzer at 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Measured: 24 months
Infant lean mass measured using an EchoMRI body composition analyzer at baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: Baseline
Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: 6 months
Infant lean mass measured using an EchoMRI body composition analyzer at 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: 12 months
Infant lean mass measured using an EchoMRI body composition analyzer at 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Measured: 24 months
Infant total body water measured using an EchoMRI body composition analyzer at baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Measured: Baseline
Infant total body water measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Measured: 6 months
Infant total body water measured using an EchoMRI body composition analyzer at 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Measured: 12 months
Infant total body water measured using an EchoMRI body composition analyzer at 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Measured: 24 months
Infant free body water measured using an EchoMRI body composition analyzer at baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Measured: Baseline
Infant free body water measured using an EchoMRI body composition analyzer at 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Measured: 6 months
Infant free body water measured using an EchoMRI body composition analyzer at 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Measured: 12 months
Infant free body water measured using an EchoMRI body composition analyzer at 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Measured: 24 months
Secondary outcomes (36)
Maternal pregravid BMI
Maternal BMI prior to pregnancy will be derived from pregravid BMI (recall during pregnancy at baseline visit) using the equation (weight in kg)/(height in m)^2.
Measured: Baseline
Maternal 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 months
Maternal resting heart rate at baseline
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Measured: Baseline
Maternal resting heart rate at 6 months
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Measured: 6 months
Maternal resting heart rate at 12 months
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Measured: 12 months
Maternal resting heart rate at 24 months
Sitting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes using a digital blood pressure monitor (Omron 3-series).
Measured: 24 months
Maternal diet at baseline
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: Baseline
Maternal diet at 6 months
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 6 months
Maternal diet at 12 months
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 12 months
Maternal diet at 24 months
24-hour diet recalls will be conducted for one week day and one weekend day. Dietary intake will be collected and analyzed using the most current version of the Nutrition Data System for Research software (NDSR) which has been used extensively in Hispanic studies.
Measured: 24 months
Infant diet at 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.
Measured: 6 months
Infant diet at 12 months
24-hour diet recalls will be conducted for one week day and one weekend day. Mothers will be interviewed to report on their infant's food intake, 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Infant feeding score assessed by Infant Feeding Questionnaire at 6 months
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Measured: 6 months
Infant feeding score assessed by Infant Feeding Questionnaire at 12 months
Infant feeding score will be assessed using the Baughcum Infant Feeding Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: concern about the child undereating or becoming underweight; concern about infant's hunger; awareness of infant's cues; concern about the infant becoming overweight or overeating; feeding the infant on schedule; using food to calm the infant; social interaction during feeding.
Measured: 12 months
Infant feeding score assessed by Infant Feeding Questionnaire at 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.
Measured: 24 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at baseline
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: Baseline
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: 6 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: 12 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 24 months
Infant feeding style score will be assessed using the Thompson Infant Feeding Style Questionnaire. Questions are scored using the following scale: 1-5; disagree, slightly disagree, neutral, slightly agree, agree. Average scores will be used to determine the following constructs: laissez-faire; pressuring; restrictive; responsive; and indulgent.
Measured: 24 months
Infant behavior score assessed by Infant Behavior Questionnaire at baseline
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Measured: Baseline
Infant behavior score assessed by Infant Behavior Questionnaire at 6 months
Infant behavior score will be assessed using the Rothbart Infant Behavior Questionnaire. Questions are scored using the following scale: 1-7; never, very rarely, less than half the time, about half the time, more than half the time, almost always, always. Composite scores will be used to determine the following constructs: surgency/extroversion; negative affectivity; and orienting/regulation.
Measured: 6 months
Infant behavior score assessed by 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.
Measured: 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.
Measured: 24 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at baseline
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Measured: Baseline
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months
Infant eating behavior score will be assessed using the Llewellyn Baby Eating Behavior Questionnaire. Questions are scored using the following scale: 1-5; never, rarely, sometimes, often, always. Average scores will be used to determine the following constructs: food responsiveness; satiety responsiveness; slowness in eating; enjoyment of food; and general appetite.
Measured: 6 months
Infant eating behavior score assessed by 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Breast milk composition at 6 months
Breast milk will be collected from mothers at least 1½ hours since the last feeding and while the mother has fasted at least 1 hour. Samples will be analyzed for glucose, fructose, galactose, lactose and sucrose by mass spectrometry. Samples will be available for analysis of insulin, leptin, and energy content.
Measured: 6 months
Breast milk composition at 12 months
Breast milk will be collected from mothers at least 1½ hours since the last feeding and while the mother has fasted at least 1 hour. Samples will be analyzed for glucose, fructose, galactose, lactose and sucrose by mass spectrometry. Samples will be available for analysis of insulin, leptin, and energy content.
Measured: 12 months
Breast milk composition at 24 months
Breast milk will be collected from mothers at least 1½ hours since the last feeding and while the mother has fasted at least 1 hour. Samples will be analyzed for glucose, fructose, galactose, lactose and sucrose by mass spectrometry. Samples will be available for analysis of insulin, leptin, and energy content.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start21 Sep 2017
- Primary completion21 Oct 2023
- Study completion21 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Cedars-Sinai Medical Center, Johns Hopkins University, University of California, San Diego
- Responsible party
- Principal investigator, Michael Goran, Children's Hospital Los Angeles
- Investigators
- Michael I Goran, Principal investigator, University of Southern California; Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141346
- Sponsor's protocol ID
- CHLA-18-00571
- Other IDs
- R01DK109161
- Acronym
- MAMITA
- Status last verified
- Mar 2026
- First submitted
- 1 May 2017
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Machle CJ, Berger PK, Salvy SJ, Rios C, Durazo-Arvizu R, Goran MI. Efficacy of a 24-month behavioral intervention focused on sugary beverage reduction for Latino mother-infant dyads: evidence from a randomized controlled trial. Am J Clin Nutr. 2025 Feb;121(2):355-366. doi: 10.1016/j.ajcnut.2024.11.009. Epub 2025 Jan 9.
PubMed 39909707
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Intervention for Reducing Sugary Drinks and Obesity in Hispanic Women-infants
- ClinicalTrials.gov ID
- NCT03141346
- Acronym / sponsor ID
- MAMITA / CHLA-18-00571
- Conditions
- Obesity
- Keywords
- mother, infant, nutrition, sugar, obesity, growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Cedars-Sinai Medical Center, Johns Hopkins University, University of California, San Diego
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 21 Oct 2023 (actual)
- Study completion
- 21 Oct 2023 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Control health education programA control health education program to promote general health and safety |
| Sugar Reduction Program Only | Experimental | Behavioral: Sugar reduction health education programA health education program that focuses on sugar reduction |
| Sugar Reduction Program & Water Delivery | Experimental | Behavioral: Sugar reduction health education program, Other: Home water deliveryA health education program that focuses on sugar reduction and provides home bottled water delivery |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Mothers who self-identify as Hispanic
- Mothers who have or have had singleton births
- Mothers will be recruited prior to their infant's birth or up to 1-month postpartum
- Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level
- Mothers who are habitual consumers of sugar sweetened beverages and juices
Key exclusion criteria (7 listed)
- Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers
- Physical, mental, or cognitive issues that prevent participation
- Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles
- Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs
- Clinical diagnosis of gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar reduction health education programA 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. | Behavioural | Sugar Reduction Program & Water Delivery, Sugar Reduction Program Only |
| Control health education programControl 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. | Behavioural | Control |
| Home water deliveryHome delivery of bottled water administered over 24 months | Other | Sugar Reduction Program & Water Delivery |
Primary outcome
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.
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.
36 secondary outcomes
Maternal pregravid BMI
Time frame: Baseline
Maternal blood pressure at baseline
Time frame: Baseline
Maternal blood pressure at 6 months
Time frame: 6 months
Maternal blood pressure at 12 months
Time frame: 12 months
Maternal blood pressure at 24 months
Time frame: 24 months
Maternal resting heart rate at baseline
Time frame: Baseline
Maternal resting heart rate at 6 months
Time frame: 6 months
Maternal resting heart rate at 12 months
Time frame: 12 months
Maternal resting heart rate at 24 months
Time frame: 24 months
Maternal diet at baseline
Time frame: Baseline
Maternal diet at 6 months
Time frame: 6 months
Maternal diet at 12 months
Time frame: 12 months
Maternal diet at 24 months
Time frame: 24 months
Infant diet at 6 months
Time frame: 6 months
Infant diet at 12 months
Time frame: 12 months
Infant diet at 24 months
Time frame: 24 months
Infant feeding score assessed by Infant Feeding Questionnaire at baseline
Time frame: Baseline
Infant feeding score assessed by Infant Feeding Questionnaire at 6 months
Time frame: 6 months
Infant feeding score assessed by Infant Feeding Questionnaire at 12 months
Time frame: 12 months
Infant feeding score assessed by Infant Feeding Questionnaire at 24 months
Time frame: 24 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at baseline
Time frame: Baseline
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months
Time frame: 6 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months
Time frame: 12 months
Infant feeding style score assessed by Infant Feeding Style Questionnaire at 24 months
Time frame: 24 months
Infant behavior score assessed by Infant Behavior Questionnaire at baseline
Time frame: Baseline
Infant behavior score assessed by Infant Behavior Questionnaire at 6 months
Time frame: 6 months
Infant behavior score assessed by Early Child Behavior Questionnaire at 12 months
Time frame: 12 months
Infant behavior score assessed by Early Child Behavior Questionnaire at 24 months
Time frame: 24 months
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at baseline
Time frame: Baseline
Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months
Time frame: 6 months
Infant eating behavior score assessed by Child Eating Behavior Questionnaire at 12 months
Time frame: 12 months
Infant eating behavior score assessed by Child Eating Behavior Questionnaire at 24 months
Time frame: 24 months
Breast milk composition at baseline
Time frame: Baseline
Breast milk composition at 6 months
Time frame: 6 months
Breast milk composition at 12 months
Time frame: 12 months
Breast milk composition at 24 months
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Derived from this study: PubMed 39909707Machle CJ, Berger PK, Salvy SJ, Rios C, Durazo-Arvizu R, Goran MI. Efficacy of a 24-month behavioral intervention focused on sugary beverage reduction for Latino mother-infant dyads: evidence from a randomized controlled trial. Am J Clin Nutr. 2025 Feb;121(2):355-366. doi: 10.1016/j.ajcnut.2024.11.009. Epub 2025 Jan 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael I Goran principal investigator
University of Southern California; Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar reduction health education program and Home water delivery in people with Obesity, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal height at baseline (time frame: Baseline). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.