- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02031185
A Wearable mHealth Device to Promote Teenagers' Physical Activity
A Wearable mHealth Device to Promote Teenagers' Physical Activity: A Pilot RCT
Due to disparities in childhood obesity, interventions for physical activity promotion and obesity prevention for low socioeconomic and racial/ethnic minority children and adolescents are vital to address disparities across the lifespan. Mobile health applications (mHealth apps) are a rapidly growing and promising approach for interactive and individualized interventions for disease prevention. Smart phones are a promising platform to reach racial/ethnic minority and lower income groups due to high rates of adoption of smart phone usage among these groups When paired with wearable sensing devices, mHealth apps for smart phones can collect data and provide feedback to users in real time. In a study among university students regarding mHealth apps, participants expressed interest in the "ability to record and track behaviors and goals and the ability to acquire advice and information 'on the go'". For physical activity in particular, wearable physical activity monitors designed for consumers that objectively measure and display data related to an individual's physical activity on smart phones through mHealth apps have become widely available and affordable. These wearable devices wirelessly upload data and provide users with physical activity data visualization and goal setting features that can be customized for each user via internet-based applications for smart phones, tablets, and/or computers. While several internet-based behavioral programs to promote pediatric physical activity have been reported in a recent review, none examined wearable sensing devices coupled with mHealth apps. Similarly, a 2013 review on mHealth technologies for physical activity assessment and promotion reported no studies that used wearable sensing devices for intervention delivery and called for research to evaluate feasibility.
The Primary Goal is to conduct a pilot randomized controlled trial (RCT) of the FitBit Flex, a popular wearable physical activity sensing device that allows data visualization and goal setting on smart phones. The target population will be adolescents ages 14-18 years old in the Seattle-metro area (n=40) with approximately 50% from low income households or belonging to a racial/ethnic minority. We will target this older age group since they have the lowest levels of physical activity among the pediatric population. This pilot study will provide feasibility and preliminary data for a future R01-funded RCT of the Flex mHealth device and app.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98145-5005
- Seattle Children's Research Institute
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 14-18 years old
- lives in the Seattle-metro area
- able to complete forms in English
- no restrictions by a health care provider on physical activity or walking
- own a smart phone or similar FitBit compatible mobile device (e.g. iPod Touch)
- agree to install and share data from the FitBit Flex smart phone app with the investigators
- attends study high school or health clinic or receives and clicks on a Facebook advertisement for the study
Exclusion Criteria:
- has been restricted by a health care provider for physical activity or walking
- does not live in the Seattle-metro area
- does not attend a study school or clinic, or did not receive a Facebook advertisement for the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control de lista de espera
Sin intervención
|
|
|
Experimental: FitBit only
Participants will use the FitBit device
|
Participants will use the FitBit device
|
|
Experimental: FitBit and Text Messages
Participants will use the FitBit device and receive daily affective text messages
|
Participants will use the FitBit device and receive daily affective text messages
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Post-intervention daily steps
Periodo de tiempo: Measured during weeks 3-4 of the intervention
|
Measured during weeks 3-4 of the intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pre-intervention daily steps
Periodo de tiempo: Baseline
|
Baseline
|
|
|
Pre-intervention moderate-to-vigorous physical activity (MVPA)
Periodo de tiempo: Baseline
|
Accelerometry
|
Baseline
|
|
Post-intervention moderate-to-vigorous physical activity
Periodo de tiempo: During weeks 3-4 of the intervention
|
accelerometry
|
During weeks 3-4 of the intervention
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jason A Mendoza, MD, MPH, University of Washington
- Investigador principal: Megan Moreno, MD, MPH, University of Washington
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- SCRI-24100018
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. .