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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL087923-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| After-school exercise program | Experimental | 40 min/day vigorous aerobic games after school |
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| Sedentary after-school program | Active Comparator | Attention-control condition similar to experimental condition with the exception of exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Heart rate monitors worn by each child at each session |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Liver Fibrosis | Change in Fibroscan transient elastography measure | Baseline, 8 Months |
| Change in Liver Inflammation | Change in ratio of aspartate aminotransferase to alanine aminotransferase (AST/ALT), C-reactive protein |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine L Davis, PhD | 706-721-9551 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Prevention Institute | Augusta | Georgia | 30912 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| After-school program | Behavioral | Supervised recreational program with token economy |
|
| Baseline, 8 Months |
| Change in Quality of Life | Change in PedsQL questionnaire responses | Baseline, 8 Months |
| 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). | Baseline |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |