- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03361644
The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity
Przegląd badań
Status
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Virginia
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Henrico, Virginia, Stany Zjednoczone, 23239
- Children's Hospital of Richmond at VCU Healthy Lifestyles Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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;
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Cardiorespiratory fitness
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Body Mass Index (BMI)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 12 weeks
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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
Ramy czasowe: 12 weeks
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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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Edmond P Wickham, MD, VCU Departments of Pediatrics and Internal Medicine
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HM20010365
- R21HD090448 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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