Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- 1. At least one parent or the child self-identifies as Hispanic or Latino.
- 2. BMI ≥ 50th percentile for age and sex.
- 3. Age ≥ 6 years and ≤ 9 years
- 4. Tanner stage 1 by self and/or parental report
- 5. Normal ALT on screening labs (≤23 IU for girls, ≤26 IU for boys)
- 6. Written informed consent from parent or legal guardian, assent from child
- 1. Known diagnosis of chronic liver disease other than NAFLD and "fatty liver"
- 2. History of significant depression
- 3. Implanted metal or other implant (braces ok), or claustrophobia or other reason that contraindicates MRI
- 4. Type 2 diabetes (Hemoglobin A1c \> 6.4% on screening labs or chronic diagnosis)
- 5. Plans to move within the next 12 months
- 6. Current or previous participation in a weight loss program or obesity treatment program or clinic
- 7. Cancer or history of cancer
- 8. Recipient of a liver transplant
- 9. Chronic use (in the last year) of medications known to cause NAFLD or fatty liver (TPN, amiodarone, chronic oral steroids, etc.)
- 10. Intellectual disability or major psychiatric disorder limiting informed assent
- 11. At risk for eating disorder by screening instrument
- 12. Participants who are currently enrolled in a clinical trial or have received an investigational product within the last 60 days
- 13. Participants who are not able or willing to comply with the diet protocol or have any other condition or circumstance that would impede compliance or hinder completion of the study in the opinion of the investigator
- 14. Children who spend more than 1 night per week consistently in another household
Ages Eligible for Study
6 Years to 9 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
Yes