Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children

Not Applicable

Completed

• Conditions: Overweight and Obesity; Non-alcoholic Fatty Liver Disease
• Interventions: Behavioral: Exercise; Behavioral: After-school program

• Registration Number: NCT02383485
• Lead Sponsor: Augusta University

Brief Summary

Nonalcoholic fatty liver disease is a serious health condition in overweight children which can lead to heart disease. This project will examine the links between liver health and cardiovascular risk factors in overweight and obese children, and will test the effect of a long-term after-school exercise program.

Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.

Detailed Description

This is an ancillary study adding cardiometabolic outcome measures to an ongoing NIH-funded randomized trial of exercise in overweight children ("SMART study," R01 HL087923, P.I. Davis, NCT02227095). This presents the opportunity to obtain detailed measures of liver and vascular health to provide information about the effects of exercise on these conditions.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2013-05
• Study Completion: 2014-04
• Status Verified: 2015-03
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-04
• Last Update Submitted: 2015-03-04
• Study First Posted: 2015-03-09
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• 8-11 years of age
• Overweight or obese (BMI-for-age >= 85th percentile)
• Able to participate in exercise testing and intervention
• Participating in the SMART Study

Exclusion Criteria

• Medical condition or medications that would interfere with measurements
• Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week
• T-score > 75 on the BRIEF Behavior Regulation scale to avoid program disruption
• Unable to complete magnetic resonance imaging.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
After-school exercise program	After-school program	40 min/day vigorous aerobic games after school
After-school exercise program	Exercise	40 min/day vigorous aerobic games after school
Sedentary after-school program	After-school program	Attention-control condition similar to experimental condition with the exception of exercise

Primary Outcome Measures

Name	Time	Method
Change in Liver Fat	Baseline, 8 Months	Change in the proportion of liver fat via MRI
Change in Arterial Stiffness	Baseline, 8 Months	Change in carotid-femoral pulse wave velocity

Secondary Outcome Measures

Name	Time	Method
Change in Liver Fibrosis	Baseline, 8 Months	Change in Fibroscan transient elastography measure
Change in Liver Inflammation	Baseline, 8 Months	Change in ratio of aspartate aminotransferase to alanine aminotransferase (AST/ALT), C-reactive protein
Change in Quality of Life	Baseline, 8 Months	Change in PedsQL questionnaire responses
Associations among Liver Fat, Fibrosis and Inflammation, Arterial Stiffness, and Other Cardiovascular Risk Indices	Baseline	At baseline, the proportion of liver fat (ascertained by MRI) will be closely related to indices of liver fibrosis (as detected by transient elastography) and inflammation (ratio of aspartate aminotransferase to alanine aminotransferase, AST/ALT; C-reactive protein, CRP), and to arterial stiffness and other indices of cardiovascular risk (body fat (DXA), visceral fat (MRI), aerobic fitness, insulin resistance, adiponectin, dyslipidemia).

Trial Locations

Locations (1)

Georgia Prevention Institute; 🇺🇸 Augusta, Georgia, United States