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

Augusta University

Status: Completed

Conditions: Overweight and Obesity; Non-alcoholic Fatty Liver Disease

Treatments: Behavioral: Exercise; Behavioral: After-school program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02383485

R01HL087923-02S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 patients

Sex: All

Ages: 8 to 11 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

After-school exercise program

Experimental group

Description:

40 min/day vigorous aerobic games after school

Treatment:

Behavioral: After-school program

Behavioral: Exercise

Sedentary after-school program

Active Comparator group

Description:

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

Treatment:

Behavioral: After-school program