Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT06768320
Status:
WITHDRAWN
Last Update Posted:
2025-11-20
First Post:
2025-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treating Toddler Obesity by Treating the Parent/Caregiver Obesity With Weight Loss Medications
Sponsor:
Loma Linda University
Organization:
Study Overview
Official Title:
Parent Toddler Obesity Study (PTOS)
Status:
WITHDRAWN
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficult to recruit. an unexpected result is the easy availability of GLP 1 medication to the general public.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTOS
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: