ACTIVE_NOT_RECRUITING

Prevention of NAFLD in Hispanic Children

Conditions

Non-Alcoholic Fatty Liver Disease Latino Children Pre-puberal Low Free sugar diet (LFSD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prevention of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanic Children

Quick Facts

Study Start:2022-04-06

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05292352

Participation Criteria

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.

Ages Eligible for Study:6 Years to 9 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Miriam Vos, MD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University

Atlanta, Georgia, 30329

United States

Collaborators and Investigators

Sponsor: Emory University

Miriam Vos, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-06

Study Completion Date2027-01

Study Record Updates

Study Start Date2022-04-06

Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

Latino Children
Pre-puberal
Low Free sugar diet (LFSD)

Additional Relevant MeSH Terms

Non-Alcoholic Fatty Liver Disease