- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03361644
The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Virginia
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Henrico, Virginia, Spojené státy, 23239
- Children's Hospital of Richmond at VCU Healthy Lifestyles Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age of 12 to 16 years with obesity (BMI ≥95% percentile for age and gender according to the CDC Growth Charts).
- Have a parent (or legal guardian) who is willing to provide basic demographic information, complete required surveys, and attend portions of the weekly adolescent-focused behavioral weight management sessions.
- Participating parent must reside with the adolescent within a 30-mile distance of the study site.
Exclusion Criteria:
- Non-English speaking;
- Weight >300 lbs;
- Medical condition(s) that may be associated with unintentional weight change (e.g., hypothalamic injury, Prader-Willi, untreated thyroid disease or malignancy);
- Diabetes mellitus diagnosed by history or a fasting glucose ≥126 mg/dl (subjects with glucose intolerance or "prediabetes" will eligible for study participation);
- Use of insulin sensitizing agents (e.g. metformin), antihypertensive medications, medications for treatment of hyperlipidemia, oral contraceptives, oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation;
- Medical condition(s) that may be negatively impacted by high-intensity exercise training;
- Psychiatric, cognitive, developmental or physical conditions that would impair the adolescent's ability to complete assessments, participate in behavioral weight management sessions, or conduct physical activity;
- Reports of compensatory behaviors (i.e., vomiting, laxative abuse, excessive exercise) in the past 3 months;
- Current pregnancy or plan to become pregnant during study period;
- Previous participation in the TEENS study at Virginia Commonwealth University;
- Current participation in another weight loss program; or
- Personal history of weight loss surgery;
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: High-Intensity Interval Training
Brief periods of vigorous physical activity separated by short periods of rest.
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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.
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Aktivní komparátor: Moderate-Intensity Continuous Training
Physical activity at a sustained moderate heart rate.
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cardiorespiratory fitness
Časové okno: 12 weeks
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The two training methods will be compared for how they impact participants' fitness levels as assessed during a graded exercise tolerance test.
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12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Body Mass Index (BMI)
Časové okno: 12 weeks
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The two training methods will be compared for changes in participants' BMI in kg/m2
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12 weeks
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Change in Blood Lipid Levels
Časové okno: 12 weeks
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The two training methods will be compared for changes in fasting lipid levels.
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12 weeks
|
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Change in Body Composition
Časové okno: 12 weeks
|
The two training methods will be compared for differences in changes of percent body fat.
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12 weeks
|
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Participant Attendance
Časové okno: 12 weeks
|
The two training methods will be compared for differences in rates of participant attendance at intervention sessions.
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12 weeks
|
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Achievement of Heart Rate Goals.
Časové okno: 12 weeks
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The two training methods will be compared for differences in rates of achievement of heart rate goals during exercise training sessions.
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12 weeks
|
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Acceptability of exercise
Časové okno: 12 weeks
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The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.
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12 weeks
|
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Feasibility of Exercise
Časové okno: 12 weeks
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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.
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12 weeks
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Maintenance of lifestyle changes
Časové okno: 16 weeks
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The two training methods will be compared for participants' frequency of participation in physical activity 1 month after completion of the intervention.
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16 weeks
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Weight loss maintenance
Časové okno: 16 weeks.
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The two training methods will be compared for changes in BMI 1 month after completion of the intervention.
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16 weeks.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Edmond P Wickham, MD, VCU Departments of Pediatrics and Internal Medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HM20010365
- R21HD090448 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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