- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02361151
The mFIT Study (Motivating Families With Interactive Technology) (mFIT)
Enhancing Parent-Child Communication and Promoting Physical Activity and Healthy Eating Through Mobile Technology: the mFIT Study (Motivating Families With Interactive Technology)
Descripción general del estudio
Descripción detallada
Objectives and Significance. Finding scalable and engaging ways to disseminate obesity treatment and prevention for children has been challenging. Mobile applications (apps) are an engaging way to involve children in health behavior changes, capitalizing on the portability and affordability of delivering health information via mobile devices and the opportunity to use gaming to make health information entertaining. Previous research by our team, including a systematic review of commercially available mobile apps for family weight loss, physical activity, and healthy eating as well as a pilot test of commercially available apps and physical activity monitoring devices with parent-child dyads, revealed significant gaps in the available mobile tools. The proposed study will test the effectiveness of using commercially available apps and a physical activity monitoring device (Tech) compared to the apps and physical activity device plus a mobile website and theory-based family intervention that encourages increased parent-child communication about physical activity and healthy eating and family behavior change (Tech+). The two programs will be administered remotely via email, mobile apps, and a mobile website to parent-child dyads (child 9-12 years old), using over a 3-month intervention period. Parent-child dyads will be randomized to the two behavioral interventions: Tech (50 dyads) or Tech+ (50 dyads). Our proposed research has two aims:
Aim 1: Test the effectiveness of an evidence-based mobile intervention with enhanced parent/child communication (Tech+) versus commercially available products (physical activity and healthy eating apps, physical activity device) alone (Tech) for improvements in physical activity and healthy eating in parents and children.
Aim 2: Examine the impacts of evidence-based family intervention on parent-child relationship quality and communication about physical activity and healthy eating.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29208
- University of South Carolina
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participants must include 1 child (age 9-12) and their parent or guardian
- Parent not currently meeting physical activity guidelines (participants will be eligible if they currently engage in aerobic activities for less than 2 hours and 30 minutes/week and strength training <2 days/week)
- Own and use a smartphone and/or a tablet with a data plan (e.g., iPhone, iPad)
- Live in the same household as the child
- Are willing to be randomized to one of the two intervention groups
- Willing and able to be physically active
Exclusion Criteria:
- Has a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition
- Has an eating disorder
- Currently participating in a weight loss program or taking weight loss medications
- Has a major chronic diseases, including: heart disease, past incidence of stroke, uncontrolled diabetes
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 |
---|---|
Comparador activo: TECH (standard program)
Receive 3-month healthy eating and physical activity intervention delivered via email newsletters and mobile apps plus self-monitoring with paper records; based on standard behavior change recommendations and materials (e.g., Diabetes Prevention Program) Intervention: remotely-delivered evidence-based intervention to support healthy eating and physical activity; use of supporting app-based games and activities and self-monitoring. |
Weekly newsletter with health information, mobile apps, and self-monitoring materials
|
Experimental: TECH+ (enhanced program)
Receive 3-month family-based healthy eating and physical activity intervention delivered via email newsletters and mobile apps plus self-monitoring with special study website Intervention: remotely-delivered evidence-based intervention to support healthy eating and physical activity; use of supporting app-based games and activities; enhanced self-monitoring and family activities via special study website |
Weekly newsletter with health information, mobile apps, and self-monitoring materials along with theory-based mobile web intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Bouts of moderate-to-vigorous physical activity (via accelorometers)
Periodo de tiempo: 12 weeks
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12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Gabrielle Turner-McGrievy, PhD, MS, RD, University of South Carolina
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 (Actual)
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
- Pro00038855
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. .
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