Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial
2017年9月27日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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London、Ontario、加拿大、N6A 6K1
- London Knights
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Sarnia、Ontario、加拿大、N7S 6K4
- Sarnia Sting
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
男性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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
其他名称：
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无干预：Usual-care wait-list control
No active intervention (usual care)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Weight loss (absolute and percentage)
大体时间：12 weeks
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Measured using digital weight scale
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Weight loss (absolute and percentage)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年4月1日
初级完成 (实际的)
2015年8月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2015年2月26日
首先提交符合 QC 标准的
2015年3月18日
首次发布 (估计)
2015年3月24日
研究记录更新
最后更新发布 (实际的)
2017年10月2日
上次提交的符合 QC 标准的更新
2017年9月27日
最后验证
2017年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Hockey FIT Program的临床试验
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University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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Oregon Health and Science University招聘中肌萎缩侧索硬化症 | 肌肉萎缩症 | 脊髓损伤 | 多系统萎缩 | 帕金森病和帕金森综合症 | 成人脑肿瘤 | 闭锁综合症 | 脑干中风美国
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The University of Hong KongSydney Children's Hospitals Network; SAHK招聘中