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| ID | Type | Description | Link |
|---|---|---|---|
| USDA/ARS 6026-10700-001-000D | Other Grant/Funding Number | United States Department of Agriculture (USDA) - Agricultural Research Service (ARS) | |
| U1111-1339-4285 | Registry Identifier | World Health Organization (WHO) Universal Trial Number |
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The goal of this clinical trial is to learn how exercise and diet quality affect the health of adolescents with obesity. The main questions it aims to answer are:
Researchers will compare four groups to see how exercise and diet impact health:
During the 12-week study, participants will attend three study visits to:
The Level Up! study is a 12-week randomized controlled trial designed to investigate the independent and combined effects of exercise training and dietary enrichment on cardiometabolic health in adolescents with obesity. The study will enroll adolescents participating in an obesity treatment program. Participants will be randomly assigned to one of four groups: standard of care, exercise, dietary, or combined exercise and dietary intervention.
Each participant will attend three assessment visits at baseline, week 6, and week 12 at the Arkansas Children's Nutrition Center (ACNC). The following key measurements will be conducted:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants receive the standard of care for treating Class I and II obesity. | |
| Exercise intervention | Experimental | In addition to the standard of care, participants engage in exercise coaching and a 12-week exercise program, encompassing three 60-minute supervised sessions per week. |
|
| Nutritional Intervention | Experimental | In addition to the standard of care, participants receive dietary coaching and engage in a 12-week daily dietary program enriched with a blend of fruits and vegetables. |
|
| Exercise and Nutritional Intervention | Experimental | In addition to the standard of care, participants receive a combined exercise and dietary intervention, as described in the other two intervention arms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | In addition to the standard of care, participants engage in exercise coaching and a 12-week exercise program, encompassing three 60-minute supervised sessions per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Group differences in composite score of cardiometabolic health changes over time. | The primary outcome is a composite score of cardiometabolic health status. The score is calculated as the mean of specific z-scores for the following markers: fasting triglycerides (mg/dL), total cholesterol/HDL-cholesterol ratio, HOMA2-IR, systolic blood pressure (mmHg), fat-mass-index [whole-body fat mass (kg)/height² (m²)], and inverse peak oxygen uptake (mL O₂/kg/min). The composite score is computed as the mean of the standardized z-scores for each marker, providing an overall measure of cardiometabolic health status. | Baseline, 6 weeks, and 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Group differences in low-density lipoprotein (LDL) cholesterol (mg/dL) changes over time. | Baseline, 6 weeks, and 12 weeks. | |
| Group differences in fow-mediated dilation (%) changes over time. | Baseline, 6 weeks, and 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Aston, MPH | Contact | 501-364-3055 | AstonHJ@archildrens.org | |
| Florêncio Sousa, Ph.D. | Contact | JFDinizdesousa@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elisabet Borsheim, Ph.D | Arkansas Children's Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | 72202 | United States |
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| Nutritional Intervention | Behavioral | In addition to the standard of care, participants receive dietary coaching and engage in a 12-week daily dietary program enriched with a blend of fruits and vegetables. |
|
| Group differences in liver steatosis (dB/m) changes over time. | Baseline and 12 weeks. |
| Group differences in appendicular lean mass index changes over time. | Baseline, 6 weeks, and 12 weeks. |
| Arkansas Children's Nutrition Center | Little Rock | Arkansas | 72202 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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