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

27 de junho de 2017 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

19 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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 -

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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 Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Time spent in Moderate to Vigorous Physical Activity (MVPA), measured by SenseWear Mini accelerometer
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Time spent in sedentary behaviours, measured by SenseWear Mini accelerometer
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de fevereiro de 2015

Conclusão Primária (Real)

1 de maio de 2016

Conclusão do estudo (Real)

1 de junho de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

5 de janeiro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de janeiro de 2015

Primeira postagem (Estimativa)

13 de janeiro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de junho de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de junho de 2017

Última verificação

1 de junho de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • H12-02526

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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