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

Launched by LOMA LINDA UNIVERSITY · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how helping parents or caregivers lose weight can also help their toddlers who are struggling with obesity. The study will provide parents with a free online nutrition program, and they may also have the option to take weight loss medications. By improving what parents eat and how they manage their own weight, the hope is that the environment for toddlers will also improve, making it easier for them to maintain a healthy weight.

To be eligible for this study, parents need to identify as Hispanic/Latino or African American, have a body mass index (BMI) of 30 or higher, and be stable in their weight for the last three months. They also need to be fluent in English. Toddlers must be between 12 and 36 months old, have a BMI that is in the 95th percentile or higher for their age and gender, and spend a lot of time with the participating parent. It’s important to note that there are certain health conditions and medications that might prevent both parents and toddlers from participating. If you qualify, you can expect to take part in a supportive program aimed at creating healthier habits for the whole family.

Gender

ALL

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