Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

PAthway To Health (PATH): Fostering Culturally Appropriate Physical Activities in Indigenous Communities (PATH)

27 de junio de 2017 actualizado por: Linda Li, University of British Columbia

PAthway To Health (PATH): Fostering Culturally Appropriate Physical Activities Using Digital Technology in Indigenous Communities

Being physically active is important for everyone's health, but it is often challenging for people to start and sustain an activity routine. The investigators will develop and pilot test the PATH (PAthway To Health) program with Indigenous communities served by the Kwakiutl District Council (KDC) Health on North Vancouver Island. The project idea was conceived through a partnership between the communities and University of British Columbia health researchers. The PATH program will include an education sessions on how to be active, physical activity coaching by community health workers, and the use of Fitbit Flex (a wearable activity tracker). The investigators will develop a culturally appropriate online application to pair with Fitbit, which will provide instant feedback to individuals about their activity level. 60 community members will be recruited to test the PATH program. Their physical activity level, health status and use of activity resources at KDC Health Centres will be assessed.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Background: Promoting an active lifestyle is a priority identified by the communities served by KDC Health. Statistics Canada estimates obesity in one in four adults based on 2007-2009 data, with higher prevalence among Indigenous people compared to non-Aboriginal population (between 26% and 36% among adults living off-reserve and on-reserve, respectively). Furthermore, Indigenous people also report higher prevalence of obesity associated complications, including diabetes, cardiovascular disease, and arthritis. The association between physical inactivity and obesity suggests that increasing physical activity is important.

KDC Health offers a variety of free programs to community members, however, the use of these services has been low. KDC Health has previously partnered with the CIHR-funded IMPAKT project, and has expressed a strong interest in developing an intervention to improve health and wellness in the communities.

Objectives:

  1. To determine whether the PATH program can improve physical activity participation in the communities served by KDC Health.
  2. To assess the effect of this program on reducing sedentary time, and increasing the use of health promotion and wellness services offered by KDC Health
  3. To assess the correlation of physical activity levels and the secondary outcome measures among individuals who are living in the same household.

Methods: The investigators will conduct a community-based proof-of-concept randomized controlled trial (RCT) with 60 eligible participants. Only 1 member per household will be enrolled. If more than 1 member is interested, they will select 1 person by consensus or by a random draw.

After obtaining the baseline measures, participants will be randomly assigned to the 'Now Group' (target=30) or 'Later Group' (target=30).

The Now Group will participate in a brief education session held at the KDC Health Centre, use a wearable physical activity tracker (Fitbit Flex), and physical activity mentoring by a KDC Health Staff (the Activity Mentors). The Activity Mentors have received training for the project from the Principal Investigator. In Month 1-2, participants will meet with their Activity Mentor once every 2 weeks to review their physical activity status, activity goals, and the health programs available at the Centre. In Month 3-4, they will continue to use Fitbit Flex but will no longer have regular meetings with the Activity Mentor.

The Later Group will receive intervention two months later (i.e., Month 3-4).

The primary outcome measure will be the time spent in moderate/vigorous physical activity. In addition, time spent in sedentary behaviours will be recorded. Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, 2 months, and 4 months. Secondary outcome measures include sedentary time measured with SenseWear Mini, health status that will be measured using the SF-36 (a generic measure of health-related quality of life), and body weight. Participants' use of KDC Health programs and their motivation to be physically active will also be recorded.

At the end of the program, participants will be interviewed for 30 minutes in person about their opinion on the intervention. Interviews will focus on 1) barriers/facilitators to being physically active, 2) their experience with the intervention, and 3) the nature of activities they engage in.

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

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

    • British Columbia
      • Richmond, British Columbia, Canadá, V6X 2C7
        • Arthritis Research Canada

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

19 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria: Participants are eligible if they:

  1. Are a person from KDC Health Member Nations
  2. Are 19 years or older
  3. Have no health condition that prevents them from being physically active
  4. Are able to participate in a 4-month project -

Exclusion Criteria: Participants are not eligible to participate if they:

  1. Do not meet the criteria above
  2. Use medication that may impair activity tolerance (e.g., beta blockers),
  3. Are unable to provide informed consent -

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: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Now Group - PATH Program
The Now Group will receive the PATH program. They will participate in a brief education session, use a wearable physical activity tracker, and physical activity mentoring by an Activity Mentors. In Month 1 and 2, participants will meet with their Activity Mentor once every 2 weeks to review their physical activity status, activity goals, and the health programs available at the Centre. In Month 3 and 4, they will continue to use physical activity tracker but will no longer have regular meetings with the Activity Mentor.
A brief education session, use of a wearable physical activity tracker, and physical activity mentoring by an Activity Mentor every 2 weeks.
Comparador activo: Later Group
The Later Group will receive the PATH program in Month 1-2. Intervention will be provided two months later (i.e., Month 3 and 4).
A brief education session, use of a wearable physical activity tracker, and physical activity mentoring by an Activity Mentor every 2 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time spent in Moderate to Vigorous Physical Activity (MVPA), measured by SenseWear Mini accelerometer
Periodo de tiempo: Change from baseline in Time spent in MVPA at 2 months and 4 months
Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and Months 2 and 4.
Change from baseline in Time spent in MVPA at 2 months and 4 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time spent in sedentary behaviours, measured by SenseWear Mini accelerometer
Periodo de tiempo: Change from baseline in time spent in sedentary behaviours at 2 months and 4 months
Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and Months 2 and 4.
Change from baseline in time spent in sedentary behaviours at 2 months and 4 months
Change in Health Status, measured by SF-36 Questionnaire
Periodo de tiempo: Change from baseline health status at 2 months and 4 months
SF-36 Questionnaire
Change from baseline health status at 2 months and 4 months
Change in Body weight, measured by measured with a calibrated scale
Periodo de tiempo: Change from baseline body weight at 2 months and 4 months
Measured with a calibrated scale
Change from baseline body weight at 2 months and 4 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Linda Li, PT, PhD, Arthritis Research Canada

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)

1 de febrero de 2015

Finalización primaria (Actual)

1 de mayo de 2016

Finalización del estudio (Actual)

1 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

5 de enero de 2015

Primero enviado que cumplió con los criterios de control de calidad

12 de enero de 2015

Publicado por primera vez (Estimar)

13 de enero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de junio de 2017

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

27 de junio de 2017

Última verificación

1 de junio de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • H12-02526

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

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. .

Suscribir