Lomaira for Childhood Obesity

(PTOS Trial)

Recruiting at 1 trial location

Overseen By Warren Peters, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Loma Linda University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to treat toddler obesity by improving the toddler nutritional environment. Parents will participate in a free internet nutrition program and may also take obesity medication. These measures may improve the parental nutritional environment and in turn, improve the toddler nutritional environment as well.

Research Team

Warren C Peters, MD

Principal Investigator

Loma Linda University (School of Public Health)

Eligibility Criteria

This trial is for parents or caregivers of toddlers who are dealing with obesity. Participants should be interested in improving their own and their toddler's nutritional environment through an online nutrition program. Some will also take a weight loss medication called Lomaira.

Inclusion Criteria

Adults self-identifying as Hispanic/Latino or African American ethnicity

Toddlers self-identifying as Hispanic/Latino or African American ethnicity

My child is between 1 and 3 years old.

Exclusion Criteria

My toddler is on medication that may cause weight gain and cannot be stopped.

I am currently receiving treatment for cancer.

Adults with a history of drug or alcohol abuse

Treatment Details

Interventions

• Lomaira (Anti-obesity Medication)

Trial Overview The study is testing whether parents taking the Lomaira 8Mg Tablet, along with participating in a free internet nutrition program, can positively influence their toddler's nutritional environment and potentially reduce toddler obesity.

Participant Groups

Group I: Active Lomaira Active Control 1 Intervention

Participants will receive Lomaira 8mg for 12 weeks and off 12 weeks, will restart at week 24 for 12 weeks one tablet per day 30 minutes before a meal.

Group II: Placebo Active Control 1 Intervention

Participants will receive Placebo for 12 weeks and off 12 weeks, will restart at week 24 for 12 weeks one tablet per day 30 minutes before a meal.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+