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An Integrated Closed-loop Feedback System for Pediatric Cardiometabolic Disease (STRIVE)

31 de agosto de 2017 actualizado por: Nicolas M. Oreskovic, MD, MPH, Massachusetts General Hospital
The high prevalence and burden of cardiometabolic disease underlie the urgent need to identify novel approaches to managing and preventing cardiometabolic disease and risk. This project will test an innovative use of mobile health technology to implement a closed-loop feedback system that collects objective patient-generated data and provides clinical recommendations to modify contributing health behaviors. In addition to improving care for cardiometabolic disease, the tools and methods developed by this study for collecting patient data and providing clinical feedback could also easily be adapted and applied to a range of other health conditions, and are thus highly relevant to public health.

Descripción general del estudio

Descripción detallada

Cardiometabolic disease - a clustering of medical conditions and risk factors which includes obesity, diabetes, impaired liver function, and an increased risk in children for adult-onset cardiovascular disease - represents a major population-wide health burden in the United States. Management of cardiometabolic disease also imposes a substantial financial burden on the economy and ties up significant healthcare resources. It is well-known that many of the lifestyle and health behaviors that contribute to cardiometabolic disease are difficult to modify once established, and childhood represents an opportune time for promoting healthy behaviors. Patient-centered outcomes research (PCOR) has identified certain health behaviors as important and actionable in modifying cardiometabolic risk, namely weight management, physical activity, screen-time, sleep, and consumption of sugar-sweetened beverages. Mobile health technology (mHealth) could be used to monitor and counsel on common health behaviors associated with cardiometabolic risk, which may facilitate the inclusion of PCOR evidence on cardiometabolic disease into clinical practice. The overall goal of this research is to use mHealth technology to accelerate the uptake of PCOR findings on treatment of cardiometabolic disease. To achieve our goal, this study will develop a novel set of mHealth tools capable of collecting health behavior information and determine to what extent providing clinical feedback on these health behaviors improves obesity and health behaviors among children ages 6-12 year and their families. In this study we will develop, implement, and test the comparative clinical effectiveness of a closed-loop feedback system for collecting patient data and providing recommendations. The specific aims of this study are: 1) to develop an integrated closed-loop feedback system that incorporates longitudinal mHealth data in managing cardiometabolic disease among at-risk families, and 2) to determine the extent to which an integrated closed-loop system that provides feedback on objective patient-generated data improves cardiometabolic risk, as measured by changes in body mass index and health behaviors including, physical activity, screen-time, sleep, and sugar-sweetened beverage consumption. This research will develop novel mHealth tools and approaches that will allow healthcare providers and patients to better understand disease risk and improve disease management by collecting patient data 1) repeatedly over time, 2) simultaneously, and 3) objectively. This study is innovative because it will use mHealth tools to simultaneously collect longitudinal data on multiple health behaviors known to be associated with cardiometabolic risk, and it will offer a new approach to implementing and disseminating PCOR findings via a novel closed-loop feedback system. The high prevalence of cardiometabolic disease makes this innovative closed-loop system very relevant to public health. The mHealth tools and methods developed by this study for collecting patient data and providing clinical feedback could also easily be adapted and applied to a range of other health conditions.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

68

Fase

  • Fase temprana 1

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.

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

6 años a 12 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • ages 6-12 years
  • body mass index categorized as overweight or obese
  • followed for obesity care
  • an adult household family member with one or more elevated cardiometabolic risk, as defined by established or documented increased risk of cardiometabolic disease (overweight, obesity, hypertension, coronary artery disease, diabetes or glucose intolerance, dyslipidemia, non-alcoholic fatty liver disease, cerebrovascular disease)
  • participating parent must own Android Smartphone
  • Wi-Fi access at home
  • speak and read English

Exclusion Criteria:

  • n/a

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: intervention
Intervention subjects will receive feedback on their health behaviors along with clinical recommendations.
A wristband containing several sensors worn by participants to collect daily objective patient-generated health behavior data on physical activity, sleep, and screen time
Otros nombres:
  • sensors
A wireless scale used by participants to measure and record daily weight.
Otros nombres:
  • wireless sscale
Self-reported information on sugar sweetened beverage consumption collected via mobile messaging
Otros nombres:
  • Sugar Sweetened Beverage Assessment
A mobile application that houses study data and provides two-way messaging between the study team and study participants.
Daily feedback and weekly e-report cards on patient-generated longitudinal health behaviors along with clinical recommendations via mobile messaging
Comparador activo: control
Control subjects will receive feedback on their health behaviors for self-guided care.
A wristband containing several sensors worn by participants to collect daily objective patient-generated health behavior data on physical activity, sleep, and screen time
Otros nombres:
  • sensors
A wireless scale used by participants to measure and record daily weight.
Otros nombres:
  • wireless sscale
Self-reported information on sugar sweetened beverage consumption collected via mobile messaging
Otros nombres:
  • Sugar Sweetened Beverage Assessment
A mobile application that houses study data and provides two-way messaging between the study team and study participants.
Provide feedback on patient-generated health behaviors data, along with standard of care recommendations, for self-guided

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
BMI, Child
Periodo de tiempo: 6 months
mean change in BMI z-score
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Health Behaviors Index, Child and Adult
Periodo de tiempo: 6 months
Cardiometabolic risk will be reported as an index score, a continuous variable calculated as the sum of Z-scores of mean daily moderate-to-vigorous physical activity (minutes), mean daily sleep (minutes), mean daily screen time (minutes), and mean weekly sugar sweetened beverage intake.
6 months
BMI, Adult
Periodo de tiempo: 6 months
mean change in BMI z-score
6 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Nicolas M Oreskovic, MD, MPH, Massachusetts General Hospital

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.

Enlaces Útiles

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 (Anticipado)

1 de octubre de 2017

Finalización primaria (Anticipado)

1 de octubre de 2018

Finalización del estudio (Anticipado)

1 de octubre de 2018

Fechas de registro del estudio

Enviado por primera vez

12 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

14 de enero de 2016

Publicado por primera vez (Estimar)

20 de enero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de septiembre de 2017

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

31 de agosto de 2017

Última verificación

1 de agosto de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • R21HS024001 (Subvención/Contrato de la AHRQ de EE. UU.)

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. .

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