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Behavioral Intervention

LFSD for Preventing Fatty Liver Disease in Children

N/A
Recruiting
Led By Miriam Vos, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI ≥ 50th percentile for age and sex
Tanner stage 1 by self and/or parental report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, month 12, month 18 and month 24
Awards & highlights

Study Summary

This trial is testing if reducing dietary sugar intake can prevent NAFLD in Hispanic children before they reach puberty.

Who is the study for?
This trial is for pre-pubertal Hispanic children aged 6-9 with a BMI ≥ 50th percentile, normal liver enzymes, and no significant health issues like cancer or chronic liver diseases other than NAFLD. They must not be on certain medications, planning to move soon, or have conditions that prevent MRI scans.Check my eligibility
What is being tested?
The study tests an intensive diet intervention focused on reducing dietary sugars to prevent non-alcoholic fatty liver disease (NAFLD) in children. It's a two-year trial where the effectiveness of this Low Free Sugar Diet (LFSD) will be monitored.See study design
What are the potential side effects?
Since the intervention involves dietary changes rather than medication, side effects may include changes in bowel habits or food cravings. However, serious side effects are unlikely with diet modification.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is in the top 50% for my age and gender.
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My physical development is at the earliest puberty stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6, month 12, month 18 and month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6, month 12, month 18 and month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Percent Hepatic Steatosis by MRI-PDFF
Onset of NAFLD
Secondary outcome measures
Changes Oral Glucose tolerance test (OGTT)
Changes in BMI
Changes in Fasting insulin
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low Free Sugar Diet (LFSD) InterventionExperimental Treatment1 Intervention
The 1-year dietary intervention will be accomplished by adapting and extending a Social Cognitive Theory (SCT) guided low sugar intervention. SCT is a framework that helps explain how people regulate their behavior through control and reinforcement to achieve goal-directed behavior that can be maintained over time.
Group II: Usual Care ControlActive Control1 Intervention
Usual Care (Control group): Parents of enrolled children in the usual care group will be provided printed material on healthy family lifestyle at the beginning of the study. The control group will complete all of the same research visits and assessments as the intervention group.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,634 Previous Clinical Trials
2,559,873 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
2,607 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institute of Nursing Research (NINR)NIH
577 Previous Clinical Trials
10,375,507 Total Patients Enrolled
Miriam Vos, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
240 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
240 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

LFSD (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05292352 — N/A
Non-alcoholic Fatty Liver Disease Research Study Groups: Usual Care Control, Low Free Sugar Diet (LFSD) Intervention
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: LFSD Highlights & Side Effects. Trial Name: NCT05292352 — N/A
LFSD (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05292352 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this clinical experiment commenced?

"As displayed on clinicaltrials.gov, this medical trial is currently recruiting volunteers and has been since April 6th 2022. The details of the study have been recently modified as of April 12th 2022."

Answered by AI

What is the current enrollment of this clinical experiment?

"That is accurate. Per the information on clinicaltrials.gov, this medical trial commenced recruitment efforts on April 6th 2022 and has recently been updated as of April 12th 2022. 200 individuals are needed from one site in particular."

Answered by AI

What are the criteria for entry into this medical trial?

"This experiment seeks out 200 young individuals between the ages of 6 and 9, who have some form of liver illness. Applicants must be Hispanic or Latino (as reported by at least one parent or the child), with a BMI that is above the 85th percentile for their sex and age, Tanner stage 1 developmentally, normal ALT levels on screening labs, parental/legal guardian consent as well as assent from the child."

Answered by AI

What are the main aims of this clinical experiment?

"This clinical trial has been designed to measure the progression of hepatic steatosis for 24 months since the start of intervention. Secondary objectives include alterations in GGT, HDL, and triglyceride levels which will be determined through laboratory testing."

Answered by AI

Are individuals over 35 years of age being included in the trial?

"As detailed by the study's inclusion criteria, participants must fall between 6 and 9 years old. For younger individuals there are 33 clinical trials available while those aged 65+ have access to 320 different studies."

Answered by AI
~159 spots leftby Jun 2026