Toddler obesity study pulled before it even started
NCT ID NCT06768320
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to treat toddler obesity by improving the food environment at home. Parents would take part in a free online nutrition program and could also take weight-loss medication. The goal was to help both parent and child lose weight. However, the study was withdrawn before any participants were enrolled.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 months to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Loma Linda University
Loma Linda, California, 92350, United States
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Nutrition Research Center
Loma Linda, California, 92350, United States
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