Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children (SMART)

Exercise and Overweight Children's Cognition (Supplement)

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.

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Fatty Liver Disease; Overweight and Obesity
• Intervention / Treatment: Behavioral: Exercise; Behavioral: After-school program

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 Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Prevention Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Augusta University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Catherine L Davis, PhD, 706-721-9551

Publications and helpful links

Helpful Links

• NIH Reporter page for the grant supplement

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 9, 2015

Study Record Updates

• Last Update Posted (Estimate): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: arterial stiffness
• Additional Relevant MeSH Terms: Digestive System Diseases; Body Weight; Liver Diseases; Fatty Liver; Overweight; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: R01HL087923-02S1 (U.S. NIH Grant/Contract)