search
Back to results

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

Primary Purpose

Overweight and Obesity, Non-alcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
After-school program
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring arterial stiffness

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Georgia Prevention Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

After-school exercise program

Sedentary after-school program

Arm Description

40 min/day vigorous aerobic games after school

Attention-control condition similar to experimental condition with the exception of exercise

Outcomes

Primary Outcome Measures

Change in Liver Fat
Change in the proportion of liver fat via MRI
Change in Arterial Stiffness
Change in carotid-femoral pulse wave velocity

Secondary Outcome Measures

Change in Liver Fibrosis
Change in Fibroscan transient elastography measure
Change in Liver Inflammation
Change in ratio of aspartate aminotransferase to alanine aminotransferase (AST/ALT), C-reactive protein
Change in Quality of Life
Change in PedsQL questionnaire responses
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).

Full Information

First Posted
March 4, 2015
Last Updated
March 4, 2015
Sponsor
Augusta University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT02383485
Brief Title
Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children
Acronym
SMART
Official Title
Exercise and Overweight Children's Cognition (Supplement)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Non-alcoholic Fatty Liver Disease
Keywords
arterial stiffness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
After-school exercise program
Arm Type
Experimental
Arm Description
40 min/day vigorous aerobic games after school
Arm Title
Sedentary after-school program
Arm Type
Active Comparator
Arm Description
Attention-control condition similar to experimental condition with the exception of exercise
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Aerobic training
Intervention Description
Heart rate monitors worn by each child at each session
Intervention Type
Behavioral
Intervention Name(s)
After-school program
Intervention Description
Supervised recreational program with token economy
Primary Outcome Measure Information:
Title
Change in Liver Fat
Description
Change in the proportion of liver fat via MRI
Time Frame
Baseline, 8 Months
Title
Change in Arterial Stiffness
Description
Change in carotid-femoral pulse wave velocity
Time Frame
Baseline, 8 Months
Secondary Outcome Measure Information:
Title
Change in Liver Fibrosis
Description
Change in Fibroscan transient elastography measure
Time Frame
Baseline, 8 Months
Title
Change in Liver Inflammation
Description
Change in ratio of aspartate aminotransferase to alanine aminotransferase (AST/ALT), C-reactive protein
Time Frame
Baseline, 8 Months
Title
Change in Quality of Life
Description
Change in PedsQL questionnaire responses
Time Frame
Baseline, 8 Months
Title
Associations among Liver Fat, Fibrosis and Inflammation, Arterial Stiffness, and Other Cardiovascular Risk Indices
Description
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).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine L Davis, PhD
Organizational Affiliation
706-721-9551
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Prevention Institute
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Links:
URL
http://projectreporter.nih.gov/project_info_description.cfm?aid=7880457&icde=20104167
Description
NIH Reporter page for the grant supplement

Learn more about this trial

Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children

We'll reach out to this number within 24 hrs