- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03691545
Making Healthy Choices: Does Having an Online Health Coach Help?
6 de março de 2020 atualizado por: Jennifer Brunet, University of Ottawa
Helping Rural-living Young Adult Cancer Survivors Make Healthy Lifestyle Choices: Does Having a Telehealth Personal Health Coach Help?
Participating in regular physical activity and consuming a diet high in fruits and vegetables can aid in the management of various acute and chronic side effects of cancer treatment; however, few rural-dwelling young adult cancer survivors are active enough and consume enough fruits and vegetables to accrue benefits.
Telehealth interventions show promise for helping these young adults increase their motivation to participate in these behaviours by addressing barriers associated with accessing face-to-face behaviour counselling services (e.g., time commitment, travel distance).
Yet, few researchers have examined the feasibility and acceptability of a telehealth intervention that provides motivational support grounded in self-determination theory for these health behaviours in rural-dwelling young adult cancer survivors.
Based on previous research, the researchers reasoned that rural-dwelling young adult cancer survivors' physical activity and fruit and vegetable consumption would be more likely to increase if they participated in a telehealth intervention therefore, the researchers aim to test the feasibility, acceptability, and preliminary efficacy of the intervention.
The researchers also aim to assess if changes in perceived basic psychological need satisfaction, behaviour regulation, and perceived autonomy support are associated with changes in physical activity and fruit and vegetable consumption.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
7
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
-
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Ontario
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Ottawa, Ontario, Canadá, K1N6N5
- University of Ottawa
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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
20 anos a 39 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Are between the ages of 20-39 years
- Live in a rural area (i.e., areas with <35,000 inhabitants)
- Have completed primary treatment for non-metastatic cancer
- Are not currently meeting the American Cancer Society guidelines for physical activity and fruit and vegetable consumption
- Have access to the Internet and to audio-visual devices
- Are willing to provide informed consent to participate in this study and willing to follow study protocol
- Able to read and understand English
- Are ambulatory
Exclusion Criteria:
- Have a serious condition that precludes safe participation in physical activity
- Have symptomatic heart or vascular diseases (angina, peripheral vascular disease, congestive heart failure)
- Have severe hypertension
- Have had a recent stroke
- Have a chronic obstructive pulmonary disease
- Have severe insulin-dependent diabetes mellitus
- Have renal disease
- Have liver disease
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: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention Group
(1) 12 weekly interactive sessions with a health coach to help them set goals and make changes toward becoming physically active and consuming the recommended number of fruits and vegetables.
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This arm will receive personalized health coaching (behaviour change counseling)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000).
Prazo: Baseline (week 0) and post-intervention (week 12)
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Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Fruit and vegetable intake behaviour: Behavioural Risk Factor Surveillance System Fruit and Vegetable section (BRFSS-FV; Trowbridge, Wong, Byers, & Serdula, 1990)
Prazo: Baseline (week 0) and post-intervention (week 12)
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Change in self-reported fruit and vegetable intake (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Basic psychological needs satisfaction for physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)
Prazo: Baseline (week 0) and post-intervention (week 12)
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Change in basic psychological need satisfaction for physical activity from baseline to post-intervention, using a 1 (false) to 6 (true) scale with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Basic psychological need satisfaction for fruit and vegetable consumption: Psychological Need Satisfaction questionnaire (PNS; Deci, Ryan, Gagne, Leone, Usunov, & Kornazheva, 2001)
Prazo: Baseline (week 0) and post-intervention (week 12)
|
Change in basic psychological need satisfaction for fruit and vegetable consumption from baseline to post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Motivational regulations for physical activity: Exercise Treatment Self-Regulation Questionnaire (TSRQ-E; Williams, Deci, & Ryan, 1998)
Prazo: Baseline (week 0) and post-intervention (week 12)
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Change in motivational regulations for physical activity from baseline to post-intervention, using a 1 (not at all true) to 7 (very true) scale with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Motivational regulations for fruit and vegetable consumption: Dietary Self-Regulation questionnaire (DSR; Williams, Deci, & Ryan, 1998)
Prazo: Baseline (week 0) and post-intervention (week 12)
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Change in motivational regulations for fruit and vegetable consumption from baseline to post-intervention, using a 1 (not at all true) to 7 (very true) scale with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Perceived autonomy support: Health Care Climate Questionnaire (HCCQ; Williams, Grow, Freedman, Ryan, & Deci, 1996)
Prazo: Post-intervention (week 12)
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Level of perceived autonomy support for health behaviours post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.
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Post-intervention (week 12)
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Recruitment rates
Prazo: Duration of recruitment and intervention phase (12 weeks)
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The number of eligible participants who enrol in the study out of the number assessed for eligibility
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Duration of recruitment and intervention phase (12 weeks)
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Retention rates for intervention
Prazo: Duration of recruitment and intervention phase (12 weeks)
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The number of participants completing the 12-week intervention.
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Duration of recruitment and intervention phase (12 weeks)
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Adherence rates for intervention
Prazo: Duration of recruitment and intervention phase (12 weeks)
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The number of eligible participants completing ≥ 70% of the intervention sessions (i.e., 8/12)
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Duration of recruitment and intervention phase (12 weeks)
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Acceptability of intervention: Semi-structured interviews
Prazo: Post-intervention (12 weeks)
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Participants will be asked what they liked, disliked, and experienced during the intervention
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Post-intervention (12 weeks)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.
- Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
- Deci, E. L., Ryan, R.M., Gagne, M., Leone, D.R., Usunov, J., & Kornazheva, B.P. (2001). Need satisfaction, motivation, and well-being in the work organizations of a former eastern bloc country: A cross-sectional study of self-determination. Journal of Personality and Social Psychology, 27(8), 930-942.
- Trowbridge FL, Wong FL, Byers TE, Serdula MK. Methodological issues in nutrition surveillance: the CDC experience. J Nutr. 1990 Nov;120 Suppl 11:1512-8. doi: 10.1093/jn/120.suppl_11.1512.
- Williams, G. C., Deci, E. L., & Ryan, R. M. (1998). Building health-care partnerships by supporting autonomy: Promoting maintained behavior change and positive health outcomes. In A. L. Suchman, P. Hinton-Walker, & R. Botelho (Ed.), Partnerships in healthcare: Transforming relational process (pp. 67-87). Rochester, NY: University of Rochester Press.
- Wilson, P. M., Rogers, W. T., Rodgers, W. M., & Wild, T. C. (2006). Psychological need satisfaction in exercise scale. Journal of Sport & Exercise Psychology, 28, 231-251.
- Price J, Brunet J. Feasibility and acceptability of a telehealth behavior change intervention for promoting physical activity and fruit and vegetable consumption among rural-living young adult cancer survivors. J Psychosoc Oncol. 2021;39(6):715-733. doi: 10.1080/07347332.2021.1896616. Epub 2021 Apr 2.
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 outubro de 2018
Conclusão Primária (Real)
30 de setembro de 2019
Conclusão do estudo (Real)
30 de setembro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
27 de setembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de setembro de 2018
Primeira postagem (Real)
1 de outubro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de março de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de março de 2020
Última verificação
1 de março de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- H08-18-882
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
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