Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
17 de diciembre de 2019 actualizado por: VA Office of Research and Development
This project is Project three of a four project Prevention Coaching Lab CREATE grant entitled "Transforming Prevention into Action" aimed at effectively engaging patients and their families to improve their health and medical care.
This project will test the feasibility and effectiveness of the prevention focused, internet mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Veterans from Afghanistan and Iraq (OEF/OIF/OND) are at high risk for becoming overweight and obese.
However, existing VA programs are not designed for younger Veterans who are comfortable with technology-mediated interventions, may not yet have developed obesity-related illnesses, and contain a relatively high percentage of women compared to previous Veteran cohorts.
Technology-mediated lifestyle interventions that include continuous, objective home monitoring of physical activity, automated internet mediated feedback, and e-coaching increase physical activity and improve weight loss in non-Veteran populations.
When delivered on a large scale, such interventions represent low cost but effective alternatives to face-to-face lifestyle change interventions that can be implemented widely in the VA health care system.
Thus, this project will test the feasibility and effectiveness of the prevention focused, internet-mediated healthy lifestyle physical activity program, Stay Strong w/coaching, tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans.
Specifically, Stay Strong w/coaching relies on use of a wearable device, the Fitbit Charge 2, and incorporates coaching support, tailored messages, and personalized physical activity goals.
Stay Strong w/coaching will be compared to the use of the Fitbit Charge 2 with standard online support (Stay Strong).
Tipo de estudio
Intervencionista
Inscripción (Actual)
465
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
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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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
18 años a 64 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- OEF/OIF/OND Veteran
- Can identify a VA Medical Center and VA Health Care Provider responsible for his/her care in the system
- Interested in starting a physical activity program in the next 30 days
- Access to a computer with an internet connection and a working USB port.
- A smartphone running a compatible iOS or Android operating system.
- Younger than Age 65
Exclusion Criteria:
- Veteran self-reports that a health care provider has told the patient that it is currently unsafe to exercise in an unsupervised or unmonitored setting. (Can become eligible with written medical clearance).
- History of eating disorders or a BMI < 20
- Not competent to consent to a research study by self-reporting a legal guardian who makes medical decisions for the Veteran.
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 |
|---|---|
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Experimental: Stay Strong w/coaching
participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
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Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention.
Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study.
Pts will be asked to upload the device data at least weekly and will receive tailored push notifications.
Each week the pt will receive a new automatically calculated personalized physical activity goal.
Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support.
Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
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Comparador activo: Stay Strong
participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
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Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study.
Pts will be asked to upload the device data at least weekly.
Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device
Periodo de tiempo: Change from Baseline in objectively monitored physical activity at one year after randomization
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Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available.
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Change from Baseline in objectively monitored physical activity at one year after randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Weight as Measured From VA Medical Record
Periodo de tiempo: Change from Baseline in weight at one year after randomization
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Weights were extracted from VHA's Corporate Data Warehouse, vital signs package due to the high number of missing weights from the study provided blue tooth scale.
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Change from Baseline in weight at one year after randomization
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Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8)
Periodo de tiempo: Change from Baseline Depression score at one year after randomization
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The Personal Health Questionnaire Depression Scale (PHQ) will be administered via online survey.
Personal Health Questionnaire (8 item version),Reporting Scores on a Scale Lower Scores Indicate a Better Outcome, Range: 0-24
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Change from Baseline Depression score at one year after randomization
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Change in Pain Measures as Assessed by the VA Pain Intensity
Periodo de tiempo: Change from Baseline in Pain measures at one year after randomization
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Pain intensity will be elicited via online survey.
Neuropathic Pain in Past Week Reporting Scores on a Scale, Lower Scores Indicate a Better Outcome, Range: 0-10
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Change from Baseline in Pain measures at one year after randomization
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Laura J. Damschroder, MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI
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.
Publicaciones Generales
- Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Aug 13;19:100631. doi: 10.1016/j.conctc.2020.100631. eCollection 2020 Sep.
- Buis LR, McCant FA, Gierisch JM, Bastian LA, Oddone EZ, Richardson CR, Kim HM, Evans R, Hooks G, Kadri R, White-Clark C, Damschroder LJ. Understanding the Effect of Adding Automated and Human Coaching to a Mobile Health Physical Activity App for Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention. JMIR Res Protoc. 2019 Jan 29;8(1):e12526. doi: 10.2196/12526.
- Damschroder LJ, Buis LR, McCant FA, Kim HM, Evans R, Oddone EZ, Bastian LA, Hooks G, Kadri R, White-Clark C, Richardson CR, Gierisch JM. Effect of Adding Telephone-Based Brief Coaching to an mHealth App (Stay Strong) for Promoting Physical Activity Among Veterans: Randomized Controlled Trial. J Med Internet Res. 2020 Aug 4;22(8):e19216. doi: 10.2196/19216.
- Buis LR, Dawood K, Kadri R, Dawood R, Richardson CR, Djuric Z, Sen A, Plegue M, Hutton D, Brody A, McNaughton CD, Brook RD, Levy P. Improving Blood Pressure Among African Americans With Hypertension Using a Mobile Health Approach (the MI-BP App): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 25;8(1):e12601. doi: 10.2196/12601.
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 (Actual)
25 de septiembre de 2017
Finalización primaria (Actual)
31 de mayo de 2019
Finalización del estudio (Actual)
30 de septiembre de 2019
Fechas de registro del estudio
Enviado por primera vez
14 de enero de 2015
Primero enviado que cumplió con los criterios de control de calidad
4 de febrero de 2015
Publicado por primera vez (Estimar)
10 de febrero de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de enero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
17 de diciembre de 2019
Última verificación
1 de diciembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CRE 12-305
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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
producto fabricado y exportado desde los 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. .