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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD090448 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The study will compare the effects of High Intensity Interval Training (HIIT) with Moderate Intensity Continuous Training (CMIT) as part of a lifestyle intervention program on BMI change in adolescents age 12-16 with obesity.
Adolescents will be randomized to a 12-week lifestyle intervention including behavioral and dietary interventions, and one of two exercise training conditions, HIIT or CMIT). Adolescents in the HIIT treatment will participate in treadmill exercise in 1-minute intervals of challenging intensities with recovery periods in between, gradually increasing the number of intervals over the course of the study. Adolescents in the CMIT treatment will participate in a constant moderate intensity treadmill exercise, gradually increasing the duration of the exercise over the course of the study.
Both parents and teens will have height and weight measurements taken, complete behavior questionnaires and wear an activity monitor for one week at baseline, 12 weeks and 16 weeks.
Adolescents will have a physical exam by a study medical provider before starting the intervention. Adolescents will also have blood work, an oral glucose tolerance test, an electrocardiogram, body composition measurements and a maximal graded exercise test done at baseline, and again at one or more time points. Adolescents will also complete a detailed food log at those time points.
Adolescents will exercise at the study gym 3 evenings a week for 12 weeks. On one of those evenings teens will also attend a 60-minute individual behavioral weight management session. Nine of these are with a behavior coach, and 3 with a dietitian. Parents will also attend one introductory session with the behavior coach, join the teen for the 3 sessions with the dietitian, and review adolescent individual goals and identify parent support goals at the end of each behavior session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity Interval Training | Experimental | Brief periods of vigorous physical activity separated by short periods of rest. |
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| Moderate-Intensity Continuous Training | Active Comparator | Physical activity at a sustained moderate heart rate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Intensity Interval Training | Behavioral | Participants assigned to HIIT will participate in treadmill exercise in intervals consisting of 1 minute intervals of challenging intensities with recovery periods in between, gradually increasing the number of intervals over the course of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness | The two training methods will be compared for how they impact participants' fitness levels as assessed during a graded exercise tolerance test. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (BMI) | The two training methods will be compared for changes in participants' BMI in kg/m2 | 12 weeks |
| Change in Blood Lipid Levels | The two training methods will be compared for changes in fasting lipid levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edmond P Wickham, MD | VCU Departments of Pediatrics and Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Richmond at VCU Healthy Lifestyles Center | Henrico | Virginia | 23239 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2020 | Apr 5, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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2x3 repeated-measures randomized control trial.
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| Moderate-Intensity Continuous Training | Behavioral | Participants assigned to CMIT will participate in constant moderate intensity treadmill exercise, gradually increasing the duration of the exercise over the course of the study. |
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| 12 weeks |
| Change in Body Composition | The two training methods will be compared for differences in changes of percent body fat. | 12 weeks |
| Participant Attendance | The two training methods will be compared for differences in rates of participant attendance at intervention sessions. | 12 weeks |
| Achievement of Heart Rate Goals. | The two training methods will be compared for differences in rates of achievement of heart rate goals during exercise training sessions. | 12 weeks |
| Acceptability of exercise | The two training methods will be compared for differences in participants' reported enjoyment of the exercise session. | 12 weeks |
| Feasibility of Exercise | The two training methods will be compared for differences in participants' confidence in being able ability to continue to participate in the assigned type of exercise. | 12 weeks |
| Maintenance of lifestyle changes | The two training methods will be compared for participants' frequency of participation in physical activity 1 month after completion of the intervention. | 16 weeks |
| Weight loss maintenance | The two training methods will be compared for changes in BMI 1 month after completion of the intervention. | 16 weeks. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |