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| Name | Class |
|---|---|
| Zeepreventorium | OTHER |
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The purpose of this study is to objectify the effect of diet and exercise on early markers of atherosclerosis in obese children.
The favorable responses of combined treatment strategies, consisting of exercise training and proper diet change, for childhood and adolescent obesity on vascular health are poorly understood. The overall objective of this research project is to investigate the underlying pathophysiological mechanisms that mediate these beneficial effects.
Particularly, the following aims are set forth:
This research knowledge will be instrumental for risk stratification and clinical management aimed to improve endothelial function by limiting damage and reinforcing regenerative mechanisms in obese adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training | Experimental | Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance |
|
| Usual Care | Other | Nutritional assessment and dietary advice by general practitioner, promotion of sports activities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Behavioral | Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months | Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function | Baseline - 5 months - 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Exercise Capacity at 5 and 10 Months | Exercise capacity will be assessed using bicycle ergometry at baseline and at 5 and 10 Months | Baseline - 5 months - 10 months |
| Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months |
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Inclusion Criteria: Children with severe obesity
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Viviane M Conraads, M.D., PhD | Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeepreventorium | De Haan | 8420 | Belgium | |||
| Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Training | Exercise training: Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance |
| FG001 | Usual Care | Usual care: Nutritional assessment and dietary advice by general practitioner, promotion of sports activities |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Training | Exercise training: Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months | Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function | this was an intention to treat analysis. Some participants ended the treatment. | Posted | Median | Inter-Quartile Range | arbitrary units | Baseline - 5 months - 10 months |
|
10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Training | Exercise training: Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr. Luc bruyndonckx | University of Antwerp/Antwerp University Hospital | 003238213000 | luc.bruyndonckx@uza.be |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050197 | Atherosclerosis |
| D050177 | Overweight |
| 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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| Usual care | Behavioral | Nutritional assessment and dietary advice by general practitioner, promotion of sports activities |
|
Weight and Length will be assessed to calculate Body Mass Index(BMI) at baseline and after 5 and 10 months |
| Baseline - 5 months - 10 months |
| Edegem |
| 2650 |
| Belgium |
| Dienst Pediatrie, Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
Usual care: Nutritional assessment and dietary advice by general practitioner, promotion of sports activities
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m² |
|
|
|
|
| Secondary | Change From Baseline in Exercise Capacity at 5 and 10 Months | Exercise capacity will be assessed using bicycle ergometry at baseline and at 5 and 10 Months | this an intention to treat analysis. Some participants ended the treatment | Posted | Median | Inter-Quartile Range | watt | Baseline - 5 months - 10 months |
|
|
|
| Secondary | Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months | Weight and Length will be assessed to calculate Body Mass Index(BMI) at baseline and after 5 and 10 months | this is an intention to treat analysis. Some participants ended treatment | Posted | Mean | Standard Deviation | kg/m² | Baseline - 5 months - 10 months |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Usual Care | Usual care: Nutritional assessment and dietary advice by general practitioner, promotion of sports activities | 0 | 28 | 0 | 28 | 0 | 28 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 5 months |
|
|
| 10 months |
|
|
| 5 months |
|
|
| 10 months |
|
|