Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial
27 de setembro de 2017 atualizado por: Robert Petrella, Western University, Canada
Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial of an Exercise and Healthy Living Program for Middle-aged, Overweight and Obese Men
The Hockey Fans in Training (Hockey FIT) program aims to improve overweight men's physical fitness, eating habits and health-related lifestyle choices through a lifestyle modification program in collaboration with two Ontario Hockey League teams.
In this pilot pragmatic randomized controlled trial, the investigators plan to explore the potential for Hockey FIT to reduce a clinically important amount of weight, increase physical activity levels, and lead to improvements in other health-related outcomes.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
In the United Kingdom, the Football Fans in Training (FFIT) program was developed to encourage men to lead a healthier lifestyle through a sport-related medium. FFIT is a gender-sensitized, weight loss and healthy living program developed for delivery to overweight and obese men through professional football clubs. Published results from FFIT show that the program was able to actively recruit and engage men and for the men who participated, sustained weight loss and positive lifestyle change was observed (Hunt et al., 2014).
This study will use a two-arm, pilot pragmatic randomized controlled trial (RCT) design. The investigators will conduct the study in conjunction with two Ontario Junior A Hockey Clubs. Following assessment of eligibility and baseline measurements, men will be individually randomized (1:1; stratified by club) to either the intervention group (receiving the Hockey FIT program) or to the comparison group (usual care wait-list control). The comparison group will be offered to start the Hockey FIT program after a 12-week delay. All men (both intervention and comparison groups) will receive publicly available healthy eating and physical activity materials at baseline. Measurements will be taken at baseline and 12 weeks (both groups) and again at 12 months (intervention group only).
The results of this study will be used to inform a fully-powered RCT where the primary objective will be to determine whether, compared to the usual care wait-list control group, the Hockey FIT group will lose weight (at least 5% weight loss from baseline) at 12 months.
Tipo de estudo
Intervencional
Inscrição (Real)
80
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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London, Ontario, Canadá, N6A 6K1
- London Knights
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Sarnia, Ontario, Canadá, N7S 6K4
- Sarnia Sting
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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
35 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
- Objectively-measured body-mass index of at least 28 kg/m2
- Clear Physical Activity Readiness Questionnaire (PAR-Q) (i.e., either by answering "No" to all questions or receiving clearance from a health care provider)
Exclusion Criteria:
- Unable to comprehend letter of information and consent documentation
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: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Hockey FIT program
12-week active phase - exercise and healthy living program (1x/week; 90 minutes/session); 40-week maintenance phase (individualized approach)
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Active phase: a) Classroom-based education on successful weight management strategies and instruction on behaviour change techniques/dietary interventions; promote peer and other forms of social support; and b) Physical activity sessions in aerobic/strength/flexibility exercises.
Maintenance phase: Participants independently set new lifestyle prescriptions and goals and track their exercise, physical activity, and healthy eating with the support of a suite of free-of-charge health technology support tools
Outros nomes:
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Sem intervenção: Usual-care wait-list control
No active intervention (usual care)
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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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Weight loss (absolute and percentage)
Prazo: 12 weeks
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Measured using digital weight scale
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12 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Weight loss (absolute and percentage)
Prazo: 12 months (Hockey FIT group only)
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Measured using digital weight scale
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12 months (Hockey FIT group only)
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Average steps per day using pedometer
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured over a 7-day period using pedometers
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12 weeks (& 12 months - Hockey FIT group only)
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Total physical activity in MET-minutes/week using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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International Physical Activity Questionnaire - Short Version
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12 weeks (& 12 months - Hockey FIT group only)
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Time spent in sedentary activity using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the International Physical Activity Questionnaire - Short Version
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12 weeks (& 12 months - Hockey FIT group only)
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Eating habits: Fatty food score using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the modified Dietary Instrument for Nutrition Education
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12 weeks (& 12 months - Hockey FIT group only)
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Eating habits: fruit and vegetable score using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the modified Dietary Instrument for Nutrition Education
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12 weeks (& 12 months - Hockey FIT group only)
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Eating habits: sugary food score using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the modified Dietary Instrument for Nutrition Education
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12 weeks (& 12 months - Hockey FIT group only)
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Eating habits: Starting the conversation summary score using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by Starting the Conversation Dietary Assessment Tool
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12 weeks (& 12 months - Hockey FIT group only)
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Alcohol consumption using recall questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by a 7-day alcohol recall (number of drinks in last 7 days)
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12 weeks (& 12 months - Hockey FIT group only)
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Resting systolic blood pressure
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using automated blood pressure monitor
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12 weeks (& 12 months - Hockey FIT group only)
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Resting diastolic blood pressure
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using automated blood pressure monitor
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12 weeks (& 12 months - Hockey FIT group only)
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Waist circumference
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using tape measure
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12 weeks (& 12 months - Hockey FIT group only)
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Body mass index using height and weight measures
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Height will be measured with a portable stadiometer; weight will be measured with a digital weight scale
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12 weeks (& 12 months - Hockey FIT group only)
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Self-esteem summary score using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Summary score from Rosenberg Self Esteem Scale
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12 weeks (& 12 months - Hockey FIT group only)
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Positive affect score using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the International Positive and Negative Affect Schedule Short Form
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12 weeks (& 12 months - Hockey FIT group only)
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Negative affect score using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the International Positive and Negative Affect Schedule Short Form
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12 weeks (& 12 months - Hockey FIT group only)
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Health-related quality of life: Descriptive health state using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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EQ-5D index measured by EQ-5D-3L
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12 weeks (& 12 months - Hockey FIT group only)
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Health-related quality of life: VAS using questionnaire
Prazo: 12 weeks (& 12 months - Hockey FIT group only)
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EQ VAS measured by EQ-5D-3L
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12 weeks (& 12 months - Hockey FIT group only)
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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
- Blunt W, Gill DP, Sibbald SL, Riggin B, Pulford RW, Scott R, Danylchuk K, Gray CM, Wyke S, Bunn C, Petrella RJ. Optimization of the Hockey Fans in Training (Hockey FIT) weight loss and healthy lifestyle program for male hockey fans. BMC Public Health. 2017 Nov 28;17(1):916. doi: 10.1186/s12889-017-4926-z.
- Gill DP, Blunt W, De Cruz A, Riggin B, Hunt K, Zou G, Sibbald S, Danylchuk K, Zwarenstein M, Gray CM, Wyke S, Bunn C, Petrella RJ. Hockey Fans in Training (Hockey FIT) pilot study protocol: a gender-sensitized weight loss and healthy lifestyle program for overweight and obese male hockey fans. BMC Public Health. 2016 Oct 19;16(1):1096. doi: 10.1186/s12889-016-3730-5.
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
1 de abril de 2015
Conclusão Primária (Real)
1 de agosto de 2015
Conclusão do estudo (Real)
1 de junho de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
26 de fevereiro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de março de 2015
Primeira postagem (Estimativa)
24 de março de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de outubro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de setembro de 2017
Última verificação
1 de setembro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- pHFIT123
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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