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A Scalable Weight Control Intervention for Adolescents (TEEN JOIN)

20 de abril de 2017 actualizado por: Elissa Jelalian, The Miriam Hospital

TEEN JOIN: A Scalable Weight Control Intervention for Adolescents

Community-based programs are needed to improve dissemination of efficacious treatment for adolescent obesity. The current study aims to modify a community-based program, delivered through the YMCA, to increase its effectiveness with adolescents. Adolescents will be randomized to either a 16-week standard program (JOIN) or a targeted intervention tailored for adolescents (TEEN JOIN). Primary outcomes include changes in BMI, objectively measured physical activity, and self-efficacy, assessed at 4 months and 10 months following randomization.

Descripción general del estudio

Descripción detallada

In 2010, the U.S. Preventive Services Task Force (USPSTF) provided a Grade recommendation B (i.e. the service is recommended with moderate/high certainty of benefit) for clinicians to screen children ages 6-17 years for obesity and refer identified youth to comprehensive behavioral programs. The challenge in meeting this objective is the lack of community-based obesity treatments to which to refer, particularly for adolescents. The JOIN program, developed as a collaboration between United HealthGroup and Y-USA is a pediatric weight control intervention targeted toward a broad age range of youth from 6-17 years that is: 1) based on well established and evidence based principles; 2) delivered by YMCA facilitators within a community setting: and 3) potentially scalable nationally. Findings from a 6-month pilot study examining the effectiveness of JOIN demonstrated impressive changes in weight status for school age children, but more modest results for adolescents. The primary aim of this study is to modify the JOIN program to increase its effectiveness with adolescents while retaining its potential for scalability.

A total of 120 adolescents (ages 13-17) with BMI > 85th% and < 50 will be randomly assigned to a 16-week targeted program (TEEN JOIN), or the traditional JOIN intervention, followed by biweekly and monthly maintenance sessions. Evaluation of adolescent height, weight, objective physical activity and psychosocial outcomes will be obtained at baseline, 4 months, and 10 months. Additional outcomes will include treatment feasibility, including attendance, completion of diet and physical activity monitoring logs, and exit interviews with adolescents and parents regarding the intervention. The investigators will also obtain preliminary indicators of cost effectiveness. It is hypothesized that adolescents who are randomized to TEEN JOIN will demonstrate greater decrease in BMI at 4 and 10 months than those randomized to JOIN. It is further hypothesized that adolescents randomized to TEEN JOIN will demonstrate greater increases in participation in moderate-vigorous physical activity and greater improvements in self-concept, self-efficacy related to physical activity, and group cohesion than adolescents who receive the standard JOIN condition.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

120

Fase

  • Fase 2

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

    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Reclutamiento
        • Weight Management and Diabetes Research Center, The Miriam Hospital/Alpert Medical School of Brown University
        • Contacto:

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

13 años a 17 años (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 13 to 17 years
  • BMI > 85th percentile and absolute BMI < 50
  • have at least one parent available to provide consent and participate in sessions
  • speak English
  • agree to study participation and random assignment

Exclusion Criteria:

  • currently involved in another weight loss program
  • have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity
  • developmentally delayed such that the intervention materials will not be appropriate
  • in treatment for a major psychiatric disorder, including an eating disorder, or are diagnosed with a major psychiatric disorder at the time of screening.

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
Comparador activo: JOIN FOR ME
The JOIN for ME curriculum includes 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Weekly meetings are scheduled for 60 minutes and are facilitated by a YMCA coach. Interventions include behavioral weight control and parent-based incentives. Parents attend group at weeks 1, 2 and 16 with their teen.
Prescription of diet & physical activity and behavioral strategies for weight control
Adolescents earn reinforcements from their parents (outside of group)
Experimental: TEEN JOIN
Similar to the JOIN FOR ME condition, adolescents in the TEEN JOIN condition attend 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Interventions include behavioral weight control, group-based physical activity, and group-based incentives. Parents attend separate meetings at weeks 1, 2, and 16.
Prescription of diet & physical activity and behavioral strategies for weight control
Teens exercise for 60 minutes with their group
Adolescents earn reinforcements within group

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change in Body Mass Index (BMI, kg/m2)
Periodo de tiempo: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband
Periodo de tiempo: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Objectively-measured moderate and vigorous physical activity
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Self-Efficacy Questionnaire
Periodo de tiempo: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Adolescents' confidence in their ability to lose weight and engage in physical activity
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)

Colaboradores e Investigadores

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

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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

1 de septiembre de 2014

Finalización primaria (Anticipado)

1 de julio de 2017

Finalización del estudio (Anticipado)

1 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

21 de abril de 2015

Primero enviado que cumplió con los criterios de control de calidad

21 de abril de 2015

Publicado por primera vez (Estimar)

24 de abril de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de abril de 2017

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

20 de abril de 2017

Última verificación

1 de abril de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 1R34DK10098101A1

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. .

Ensayos clínicos sobre Behavioral weight control

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