Status:
ACTIVE_NOT_RECRUITING
Prevention of NAFLD in Hispanic Children
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
6-9 years
Phase:
NA
Brief Summary
This is a 2 year clinical trial testing an intensive intervention to reduce dietary sugars as a means to prevent non-alcoholic fatty liver disease (NAFLD) in pre-pubertal Hispanic children.
Detailed Description
The number of children experiencing obesity and the chronic diseases associated with it have risen dramatically in recent decades. This includes non-alcoholic fatty liver disease (NAFLD). NAFLD is an ...
Eligibility Criteria
Inclusion
- At least one parent or the child self-identifies as Hispanic or Latino.
- BMI ≥ 50th percentile for age and sex.
- Age ≥ 6 years and ≤ 9 years
- Tanner stage 1 by self and/or parental report
- Normal ALT on screening labs (≤23 IU for girls, ≤26 IU for boys)
- Written informed consent from parent or legal guardian, assent from child
Exclusion
- Known diagnosis of chronic liver disease other than NAFLD and "fatty liver"
- History of significant depression
- Implanted metal or other implant (braces ok), or claustrophobia or other reason that contraindicates MRI
- Type 2 diabetes (Hemoglobin A1c \> 6.4% on screening labs or chronic diagnosis)
- Plans to move within the next 12 months
- Current or previous participation in a weight loss program or obesity treatment program or clinic
- Cancer or history of cancer
- Recipient of a liver transplant
- Chronic use (in the last year) of medications known to cause NAFLD or fatty liver (TPN, amiodarone, chronic oral steroids, etc.)
- Intellectual disability or major psychiatric disorder limiting informed assent
- At risk for eating disorder by screening instrument
- Participants who are currently enrolled in a clinical trial or have received an investigational product within the last 60 days
- 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
- Children who spend more than 1 night per week consistently in another household
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2027
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT05292352
Start Date
April 6 2022
End Date
January 31 2027
Last Update
November 18 2025
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30329