Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children

NCT ID: NCT02383485

Last Updated: 2015-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2014-04-30

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.

Conditions

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Overweight and Obesity Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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After-school exercise program

40 min/day vigorous aerobic games after school

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Heart rate monitors worn by each child at each session

After-school program

Intervention Type BEHAVIORAL

Supervised recreational program with token economy

Sedentary after-school program

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

Group Type ACTIVE_COMPARATOR

After-school program

Intervention Type BEHAVIORAL

Supervised recreational program with token economy

Interventions

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Exercise

Heart rate monitors worn by each child at each session

Intervention Type BEHAVIORAL

After-school program

Supervised recreational program with token economy

Intervention Type BEHAVIORAL

Other Intervention Names

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Aerobic training

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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Catherine Davis

Professor of Pediatrics, Graduate Studies and Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine L Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

706-721-9551

Locations

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Georgia Prevention Institute

Augusta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL087923-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL087923-02S1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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