Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity

5 de abril de 2021 actualizado por: Virginia Commonwealth University
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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Virginia
      • Henrico, Virginia, Estados Unidos, 23239
        • Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 16 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: High-Intensity Interval Training
Brief periods of vigorous physical activity separated by short periods of rest.
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.
Comparador activo: Moderate-Intensity Continuous Training
Physical activity at a sustained moderate heart rate.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cardiorespiratory fitness
Periodo de tiempo: 12 weeks
The two training methods will be compared for how they impact participants' fitness levels as assessed during a graded exercise tolerance test.
12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Body Mass Index (BMI)
Periodo de tiempo: 12 weeks
The two training methods will be compared for changes in participants' BMI in kg/m2
12 weeks
Change in Blood Lipid Levels
Periodo de tiempo: 12 weeks
The two training methods will be compared for changes in fasting lipid levels.
12 weeks
Change in Body Composition
Periodo de tiempo: 12 weeks
The two training methods will be compared for differences in changes of percent body fat.
12 weeks
Participant Attendance
Periodo de tiempo: 12 weeks
The two training methods will be compared for differences in rates of participant attendance at intervention sessions.
12 weeks
Achievement of Heart Rate Goals.
Periodo de tiempo: 12 weeks
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
Periodo de tiempo: 12 weeks
The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.
12 weeks
Feasibility of Exercise
Periodo de tiempo: 12 weeks
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
Periodo de tiempo: 16 weeks
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
Periodo de tiempo: 16 weeks.
The two training methods will be compared for changes in BMI 1 month after completion of the intervention.
16 weeks.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Edmond P Wickham, MD, VCU Departments of Pediatrics and Internal Medicine

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de febrero de 2018

Finalización primaria (Actual)

13 de enero de 2020

Finalización del estudio (Actual)

20 de febrero de 2020

Fechas de registro del estudio

Enviado por primera vez

17 de noviembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

28 de noviembre de 2017

Publicado por primera vez (Actual)

5 de diciembre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de abril de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

5 de abril de 2021

Última verificación

1 de abril de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HM20010365
  • R21HD090448 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir