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Completed

NCT Number: NCT02383485

Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children

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.

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Key information

Conditions

Overweight and Obesity Body Weight Digestive System Diseases Fatty Liver Liver Diseases Non-Alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

Heart rate monitors worn by each child at each session

Other names: Aerobic training

After-school program

Behavioral

Supervised recreational program with token economy

Primary outcomes

  1. Change in Liver Fat

    Time frame: Baseline, 8 Months

    Change in the proportion of liver fat via MRI

  2. Change in Arterial Stiffness

    Time frame: Baseline, 8 Months

    Change in carotid-femoral pulse wave velocity

Secondary outcomes

  1. Change in Liver Fibrosis

    Time frame: Baseline, 8 Months

    Change in Fibroscan transient elastography measure

  2. Change in Liver Inflammation

    Time frame: Baseline, 8 Months

    Change in ratio of aspartate aminotransferase to alanine aminotransferase (AST/ALT), C-reactive protein

  3. Change in Quality of Life

    Time frame: Baseline, 8 Months

    Change in PedsQL questionnaire responses

  4. Associations among Liver Fat, Fibrosis and Inflammation, Arterial Stiffness, and Other Cardiovascular Risk Indices

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Exercise and Overweight Children's Cognition (Supplement)

Acronym: SMART

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Mar 9, 2015
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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