Treating Toddler Obesity by Treating the Parent/Caregiver Obesity With Weight Loss Medications (PTOS)

Parent Toddler Obesity Study (PTOS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Weight Loss; Obesity, Childhood
• Intervention / Treatment: Drug: Lomaira 8Mg Tablet

Detailed Description

Fifty parent or caregiver and toddler teams will be enrolled in a 37 week study in which the parents or caregivers will be randomized to receive either an obesity drug or a placebo, while simultaneously enrolled in the Full Plate Living lifestyle program. Study eligibility and ongoing participation will be assessed by lab results, biometric measurements and nutrition questionnaires to monitor the impact of diet and medication on the parental dietary environment. Toddler body mass index (BMI) will be calculated at study inception and completion to assess potential impact on the toddler dietary environment. Teaching will be provided to parents on healthy dietary choices, adequate sleep and stress control.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University
    • Loma Linda, California, United States, 92350
      • Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Adults

• Self-identify as being of Hispanic/Latino or African American ethnicity
• BMI ≥30 with a stable weight (no more than 5% variation during the previous 3 months) and an agreement not to initiate any other weight loss
• HbAlc ≤ 6.4
• Fluent in written and spoken English

Exclusion Criteria: Adult

• Current cancer treatment
• Have been treated with prescription drugs that promote weight loss (for example, liraglutide [Saxenda™], orlistat [Xenical®], phentermine Adipex®], phentermine/topiramate [Qsymia™], semaglutide 2.4 mg [Wegovy™], tirzepatide [Zepbound™], bupropion/naltrexone [Contrave™], phentermine [Lomaira™] or similar other weight loss medications including over-the-counter (OTC) medications (for example, Alli®). Use of obesogenic medications (including but not limited to steroids, haloperidol, clozapine, risperidone, olanzapine, amitriptyline, imipramine, paroxetine, and lithium) which cannot be substituted or stopped
• History of drug or alcohol abuse
• Nursing or planning to become pregnant in the next 10 months
• Unwilling to use accepted standards of birth control if female and before menopause age. (i.e. IUD, birth control pills/injections, tubal or vas deferens ligation) during the study and for 30 days after the study is completed. Condoms or rhythm methods are not sufficient.

Inclusion Criteria: (Toddler)

• Self-identify as being of Hispanic/Latino or African American ethnicity
• BMI ≥ 95th percentile for age, gender and height
• Age 12 to 36 months of age
• Spends at least half of its awake time per day with the P/OCG who is the consenting adult and who provides at least half of the toddler's diet on that day

Exclusion Criteria (Toddler)

• Current cancer treatment
• Use of obesogenic medications (including but not limited to steroids, haloperidol, clozapine, risperidone, olanzapine, amitriptyline, imipramine, paroxetine, and lithium) which cannot be substituted or stopped
• Genetic disorders and/or physical or mental handicaps that would limit participation in the study and/or the lifestyle intervention
• Any special dietary or exercise requirements
• Any established chromosome abnormalities that might be associated with obesity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Lomaira; 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.	Drug: Lomaira 8Mg Tablet; 8 mg tablet up to three times a day
No Intervention: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Toddler's Body Mass index (BMI) percentile at week 37	Toddler BMI will be measured at enrollment and at final study visit week 37. BMI will be calculated using the InBody Scale. This is a composite measurement consisting of height and weight.	Change between baseline visit and final study visit at week 37
Change in parent's Body Mass index (BMI) at week 37	Adults BMI will be measured at enrollment and at final study visit week 37. BMI will be calculated using the InBody Scale. This is a composite measurement consisting of height and weight.	Change between baseline visit and final study visit at week 37

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Warren C Peters, MD, Loma Linda University (School of Public Health)

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss; Pediatric Obesity; Organic Chemicals; Pharmaceutical Preparations; Dosage Forms; Amines; Phenethylamines; Ethylamines; Amphetamines; Phentermine; Tablets
• Other Study ID Numbers: IRB 5240207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No formal plans

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No