Lomaira for Childhood Obesity
(PTOS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByWarren C 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.

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.

+5 more

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

+7 more

Participant Groups

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.

2Treatment groups

Active Control

Group I: Active LomairaActive Control1 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: PlaceboActive Control1 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.