NCT06768320

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

Parent Toddler Obesity Study (PTOS)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 12 Months – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Weight Loss
• Obesity, Childhood
• Obesity

Interventions

Type	Name	Description
DRUG	Lomaira 8Mg Tablet	8 mg tablet up to three times a day

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-01-01
• Completion: 2027-11-01
• First posted: 2025-01-10
• Last updated: 2025-11-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study