NCT02383485

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

5 years

First QC Date

March 4, 2015

Last Update Submit

March 4, 2015

Conditions

Overweight and ObesityNon-alcoholic Fatty Liver Disease

Keywords

arterial stiffness

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change in Liver Fibrosis

    Baseline, 8 Months

  • Change in Liver Inflammation

    Baseline, 8 Months

  • Change in Quality of Life

    Baseline, 8 Months

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

    Baseline

Study Arms (2)

After-school exercise program

EXPERIMENTAL

40 min/day vigorous aerobic games after school

Behavioral: ExerciseBehavioral: After-school program

Sedentary after-school program

ACTIVE COMPARATOR

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

Behavioral: After-school program

Interventions

ExerciseBEHAVIORAL

Heart rate monitors worn by each child at each session

Also known as: Aerobic training
After-school exercise program
After-school programBEHAVIORAL

Supervised recreational program with token economy

After-school exercise programSedentary after-school program

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • Overweight or obese (BMI-for-age \>= 85th percentile)
  • Able to participate in exercise testing and intervention
  • Participating in the SMART Study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

OverweightObesityNon-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Catherine L Davis, PhD

    706-721-9551

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics, Graduate Studies and Physiology

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 9, 2015

Study Start

May 1, 2008

Primary Completion

May 1, 2013

Study Completion

April 1, 2014

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

US(1)