Obesity, Obesity, Childhood, Weight Loss
Conditions
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.
Interventions
DRUGLomaira 8Mg Tablet
8 mg tablet up to three times a day
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Toddler's Body Mass index (BMI) percentile at week 37 | Change between baseline visit and final study visit 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 in parent's Body Mass index (BMI) at week 37 | Change between baseline visit and final study visit 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. |
Countries
United States
Outcome results
None listed