NCT05292352

Prevention of NAFLD in Hispanic Children

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Accepted

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 has risen dramatically in recent decades. This includes non-alcoholic fatty liver disease (NAFLD). NAFLD is an excess accumulation of fat in the liver that results when children's diet and activity patterns compound the genetic risk they were born with. Excess fat in the liver increases the risk of diabetes and heart disease, as well as the chance that a liver transplant will be needed. Previous studies suggest that diets high in sugar, particularly during critical periods of development, increase children's risk of developing NAFLD. The study team has previously shown that reducing intake of free sugars (those used to sweeten foods and beverages and those found naturally in fruit juices) to very low levels reduces the amount of fat stored in the liver and improves the metabolic health of children with NAFLD. This single-site randomized clinical trial is designed to determine if following a diet very low in free sugars just before puberty, a time of increased metabolic disruption, can help to prevent NAFLD in children known to be at high risk. This trial will study free-living Hispanic children with overweight or obesity because their increased risk for NAFLD compared to non-Hispanic children has been well documented. Enrollment will include children ages 6-9 years and Tanner stage 1 living in the Atlanta metropolitan area. Recruitment is through local pediatric clinics and through parents attending diabetes and NAFLD clinics. Enrollment and informed consent are performed by members of the research team. The one-year dietary intervention will include a combination of evidence-based strategies: dietary counseling by a nutritionist using motivational interviewing and family-centered goal setting; a one-month provision of a low-free sugar diet for the entire family, and nutritionist-guided (and study-funded) grocery shopping trips every 3 months thereafter. The control group will follow their usual diet and receive similar study assessments and compensation. The primary outcome at year one is MRI-assessed change in the amount of liver fat from baseline. At 24 months, the incidence of NAFLD in the intervention group vs. the control group will be assessed (primary outcome of 24 month study). Other outcomes to be assessed at 12- and 24-months include changes in liver enzymes, glucose metabolism, dyslipidemia, body composition and metabolomics. These studies may inform the development of guidelines for clinicians, dietitians, parents, and others involved in counseling and caring for children at high risk of developing NAFLD.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
BEHAVIORAL	LFSD	Assessment of child's usual diet to assess sugar intake in relation to the total usual diet. Consultation with a nutritionist to help families identify foods high in sugar. Removal of foods and drinks high in free sugar from the home. Counseling using motivational interviewing, patient-centered goal setting to help parents and participating youth identify barriers to compliance with the intervention. Provision of a study provided LFSD with sufficient quantity to meet the needs and adapted to meet the preferences of the entire household for the first 4 weeks. Facilitated grocery shopping trips every 3 months during year 1.

Timeline

• Start date: 2022-04-06
• Primary completion: 2026-03-31
• Completion: 2027-03-31
• First posted: 2022-03-23
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States