Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT06768320
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
75 Years
Study:
NCT06768320
Study Brief:
Protocol Section:
NCT06768320