Clinical trial NCT06768320: Treating Toddler Obesity by Treating the Parent/Caregiver Obesity With Weight Loss Medications
Official title: Parent Toddler Obesity Study (PTOS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Weight Loss
Obesity, Childhood
Obesity
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Toddler's Body Mass index (BMI) percentile at week 37
timeFrame: Change between baseline visit and final study visit at week 37
measure: Change in parent's Body Mass index (BMI) at week 37
timeFrame: Change between baseline visit and final study visit at week 37
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Loma Linda
country: United States
facility: Nutrition Research Center
state: California
Study officials:
affiliation: Loma Linda University (School of Public Health)
name: Warren C Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: