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The mFIT Study (Motivating Families With Interactive Technology) (mFIT)

16 de abril de 2019 actualizado por: Brie Turner-McGrievy, University of South Carolina

Enhancing Parent-Child Communication and Promoting Physical Activity and Healthy Eating Through Mobile Technology: the mFIT Study (Motivating Families With Interactive Technology)

The high rates of childhood obesity in the US demand innovative and cost-effective weight gain prevention tools; mobile applications (apps) represent one such solution. Using a randomized design, the mFIT study tests the effectiveness of using commercially available apps and a physical activity (PA) monitoring device (Tech, n=50 parent-child dyads) compared to the apps and PA device plus a mobile website and theory-based family intervention that encourages increased parent-child communication about PA and healthy eating as well as family behavior change (Tech+, n=50 parent-child dyads).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

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

Intervencionista

Inscripción (Actual)

200

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

    • South Carolina
      • Columbia, South Carolina, Estados Unidos, 29208
        • University of South Carolina

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

9 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

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

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: 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
Bouts of moderate-to-vigorous physical activity (via accelorometers)
Periodo de tiempo: 12 weeks
12 weeks

Colaboradores e Investigadores

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

Investigadores

  • Silla de estudio: Gabrielle Turner-McGrievy, PhD, MS, RD, University of South Carolina

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 febrero de 2015

Finalización primaria (Actual)

1 de agosto de 2015

Finalización del estudio (Actual)

1 de diciembre de 2015

Fechas de registro del estudio

Enviado por primera vez

3 de febrero de 2015

Primero enviado que cumplió con los criterios de control de calidad

5 de febrero de 2015

Publicado por primera vez (Estimar)

11 de febrero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de abril de 2019

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

16 de abril de 2019

Última verificación

1 de abril de 2019

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. .

Ensayos clínicos sobre TECH

3
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