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Sugar Reduction Program for Preventing Obesity (MAMITA Trial)
N/A
Waitlist Available
Led By Michael I Goran
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Clinical diagnosis of gestational diabetes
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Summary
This trial will test whether a health education program focused on reducing sugar intake and delivering bottled water to homes can help mothers and infants avoid obesity.
Who is the study for?
This trial is for mothers who often drink sugary beverages and juices, can understand study procedures in English or Spanish at a 5th grade level, have had a single birth up to one month postpartum, and identify as Hispanic. It excludes those with major illnesses like diabetes, on weight-affecting meds, smokers or drug users, with pre-term infants or fetal abnormalities.
What is being tested?
The study tests if educating mothers about reducing sugar intake and providing home water delivery can lower obesity risk in them and their babies. Mothers-infant pairs will be randomly assigned to either standard health education (control), sugar reduction education (translation), or sugar reduction plus bottled water delivery (efficacy) over two years.
What are the potential side effects?
There are no direct medical side effects from participating in this educational program; however, changes in diet may lead to temporary adjustments such as cravings or changes in energy levels.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with gestational diabetes.
Select...
I was 18 or older when I gave birth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Infant body fat measured using an EchoMRI body composition analyzer at 12 months
Infant body fat measured using an EchoMRI body composition analyzer at 24 months
Infant body fat measured using an EchoMRI body composition analyzer at 6 months
+37 moreSecondary study objectives
Breast milk composition at 12 months
Breast milk composition at 24 months
Breast milk composition at 6 months
+33 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Sugar Reduction Program OnlyExperimental Treatment1 Intervention
A health education program that focuses on sugar reduction
Group II: Sugar Reduction Program & Water DeliveryExperimental Treatment2 Interventions
A health education program that focuses on sugar reduction and provides home bottled water delivery
Group III: ControlActive Control1 Intervention
A control health education program to promote general health and safety
Find a Location
Who is running the clinical trial?
Children's Hospital Los AngelesOTHER
244 Previous Clinical Trials
5,072,855 Total Patients Enrolled
9 Trials studying Obesity
5,096 Patients Enrolled for Obesity
University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,270 Total Patients Enrolled
33 Trials studying Obesity
12,423 Patients Enrolled for Obesity
Michael I GoranPrincipal InvestigatorUniversity of Southern California; Children's Hospital Los Angeles
2 Previous Clinical Trials
206 Total Patients Enrolled
1 Trials studying Obesity
93 Patients Enrolled for Obesity
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