Sugar Reduction Program for Preventing Obesity

(MAMITA Trial)

Overseen By Michael Goran

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Weight medications

Disqualifiers: Diabetes, Eating disorders, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if reducing sugar intake and providing bottled water can lower obesity risks in mothers and their infants. Participants will join one of three groups: a standard health education group (control health education program), a group focusing on sugar reduction (sugar reduction health education program), or a group focusing on sugar reduction plus home water delivery. It is designed for Hispanic mothers who regularly consume sugary drinks and have recently given birth to a single child. As an unphased trial, this study offers participants a unique opportunity to contribute to important research that could improve health outcomes for mothers and infants.

Will I have to stop taking my current medications?

The trial excludes participants who are on chronic medications that affect body weight, insulin resistance, or lipid profiles, so you may need to stop such medications to participate.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Research has shown that teaching people to eat less sugar is both effective and safe. Studies have found that these programs help people reduce sugar intake without harmful effects. For instance, one study found that participants who learned about nutrition reduced their sugar intake by 10% without negative side effects.

Regarding home water delivery, research suggests it is a safe and helpful way to lower obesity risk. Studies indicate that increased water availability can reduce the consumption of sugary drinks, often linked to weight gain. No evidence suggests any negative effects from providing more access to water.

These findings suggest that both the sugar reduction program and water delivery are safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they focus on reducing sugar intake, a novel approach in tackling obesity compared to standard methods like diet and exercise plans or medication. The Sugar Reduction Program is unique because it specifically educates participants on decreasing sugar consumption, which is a major contributor to obesity. Additionally, one of the treatment arms offers home bottled water delivery, which encourages replacing sugary drinks with water, potentially making it easier for participants to adopt healthier habits. This focus on sugar reduction and the convenience of water delivery could provide a practical, sustainable solution to preventing obesity, setting it apart from existing strategies.

What evidence suggests that this trial's treatments could be effective for preventing obesity?

Studies have shown that reducing sugar intake can help prevent obesity. For example, a program that taught people about nutrition helped them reduce their added sugar intake by 10%. In this trial, participants in the "Sugar Reduction Program Only" arm will receive a health education program focused on reducing sugar intake. Other research indicates that drinking fewer sugary drinks can lead to less sugar consumption, which is important for managing weight. Participants in the "Sugar Reduction Program & Water Delivery" arm will receive the same education program along with home bottled water delivery. Providing families with water deliveries at home has been linked to a significant drop in sugar intake from drinks and a lower risk of becoming overweight. These findings suggest that reducing sugar and drinking more water can effectively support weight management and prevent obesity. ^{3 6 7 8 9}

Who Is on the Research Team?

Michael I Goran

Principal Investigator

University of Southern California; Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

I regularly take medication that could affect my weight, insulin resistance, or lipid levels.

I have been diagnosed with a major illness or eating disorder.

You are currently smoking cigarettes or using recreational drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a health education program focused on sugar reduction and home bottled water delivery

24 months

In-person home visits or virtual visits via phone or video calls

Follow-up

Participants are monitored for changes in maternal and infant weight, diet, and other health metrics

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Control health education program
• Home water delivery
• Sugar reduction health education program

Trial Overview

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.

How Is the Trial Designed?

Group I: Sugar Reduction Program Only Experimental Treatment 1 Intervention

A health education program that focuses on sugar reduction

Group II: Sugar Reduction Program & Water Delivery Experimental Treatment 2 Interventions

A health education program that focuses on sugar reduction and provides home bottled water delivery

Group III: Control Active Control 1 Intervention

A control health education program to promote general health and safety

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

Obesity is a significant public health issue that increases the risk of serious health conditions like type 2 diabetes, hypertension, and heart disease, highlighting the importance of effective weight management.

A successful weight loss program should be personalized and may include dietary changes, physical activity, behavior modification, and, for some patients, medications or surgery to ensure safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and effective management of the obese patient. Collazo-Clavell, ML.[2022]

The adapted Diabetes Prevention Program (DPP) led to significant weight loss and improvements in A1C levels among incarcerated individuals, with the intervention group losing an average of 12 pounds compared to 5 pounds in the control group after 6 months.

Both the intervention and control groups showed significant decreases in BMI and A1C levels after 12 months, suggesting that even a delayed start to the program can yield beneficial cardiometabolic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention in Prison: The Diabetes Prevention Program in a Correctional Setting. Fine, A., Gallaway, MS., Dukate, A.[2022]

In a 10-week school-based program involving 63 obese children aged 5 to 12, 95% of participants lost weight, achieving an average weight loss of 4.4 kg and a 15.4% decrease in their percentage overweight.

The program was significantly more effective than no intervention, as only 21% of a control group of obese children lost weight, highlighting the importance of comprehensive behavior modification and support in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. Brownell, KD., Kaye, FS.[2018]

Citations

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At 15 months, there were smaller increases in overweight prevalence in intervention students = (0.5%) compared to control students (3.7%).

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pmc.ncbi.nlm.nih.gov

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Results from this study show an association between a relatively low-cost water availability intervention and decreased student weight.

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stanmed.stanford.edu

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Safe, free, appealing tap water can help combat childhood obesity and dental cavities because water can replace sugary drinks kids otherwise consume.

8.

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Researchers documented features of state school water quality testing programs and compared their methodologies to standard health surveillance element. The ...

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jamanetwork.com

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Effect of a Home-Visiting Intervention to Reduce Early ...

This randomized clinical trial assesses the impact of a brief home-visiting approach, Family Spirit Nurture, on sugar-sweetened beverage ...