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

211 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 the Sugar Reduction Program for Preventing Obesity safe for humans?

The Sugar Reduction Program, evaluated in various studies, appears to be safe for humans. In a study with Latino youth, reducing sugar intake did not cause any harmful effects and was associated with some health improvements. Another study showed that nutrition education programs, which may include sugar reduction, can positively impact health without adverse effects. ^{1 2 3 4 5}

How does the Sugar Reduction Program for Preventing Obesity differ from other treatments for obesity?

The Sugar Reduction Program is unique because it focuses specifically on reducing sugar intake through health education, unlike other programs that may emphasize general weight loss strategies or physical activity. This targeted approach aims to prevent obesity by addressing one of its key dietary contributors. ^{4 5 6 7 8}

What data supports the effectiveness of the Sugar Reduction Program for Preventing Obesity treatment?

Research shows that behavior modification and nutrition education, similar to the components of the Sugar Reduction Program, have been effective in helping children lose weight in school-based programs. Additionally, self-regulation techniques in dietary control have led to significant weight loss in adults, suggesting that structured programs focusing on behavior change and education can be effective in preventing obesity. ^{4 9 10 11 12}

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 have been diagnosed with a major illness or eating disorder.

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

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

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]

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]

Citations

1. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

[Self-regulation effect in dietary control of obesity]. [2011]

2. Italy pubmed.ncbi.nlm.nih.gov

[Obesity and health education in the hospital milieu]. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Weight reduction interventions for persons with a chronic illness: findings and factors for consideration. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Safe and effective management of the obese patient. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Reducing children's sugar intake through food reformulation: methods for estimating sugar reduction program targets, using New Zealand as a case study. [2023]

7. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of a program led by community workers to promote cardiometabolic health in adults in a highly marginalized Mexican municipality]. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Dietary Sugar Reduction on Biomarkers of Cardiometabolic Health in Latino Youth: Secondary Analyses from a Randomized Controlled Trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Mortality benefit of participation in BOOCS program: a follow-up study for 15 years in a Japanese working population. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Lay health educators translate a weight-loss intervention in senior centers: a randomized controlled trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Prevention in Prison: The Diabetes Prevention Program in a Correctional Setting. [2022]

12. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

[Obesity is a disease--the "School of Healthy Weight Loss" is therapeutic]. [2015]