Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exercise and Overweight Children's Cognition (Supplement)

Conditions
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Overweight and Obesity, Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: After-school program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: After-school exercise program<br>40 min/day vigorous aerobic games after school | Behavioral: Exercise<br>* Heart rate monitors worn by each child at each session<br>* Other names: Aerobic training;Behavioral: After-school program<br>* Supervised recreational program with token economy<br>|
| Active Comparator: Sedentary after-school program<br>Attention-control condition similar to experimental condition with the exception of exercise | Behavioral: After-school program<br>* Supervised recreational program with token economy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Liver Fat | Change in the proportion of liver fat via MRI | Baseline, 8 Months | 
| Change in Arterial Stiffness | Change in carotid-femoral pulse wave velocity | Baseline, 8 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Liver Fibrosis | Change in Fibroscan transient elastography measure | Baseline, 8 Months | 
| Change in Liver Inflammation | Change in ratio of aspartate aminotransferase to alanine aminotransferase (AST/ALT), C-reactive protein | Baseline, 8 Months | 
| Change in Quality of Life | Change in PedsQL questionnaire responses | Baseline, 8 Months | 
| Associations among Liver Fat, Fibrosis and Inflammation, Arterial Stiffness, and Other Cardiovascular Risk Indices | 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). | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial stiffness