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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Weight loss (absolute and percentage)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Unable to comprehend letter of information and consent documentation
结局指标
主要结局
Weight loss (absolute and percentage)
时间窗: 12 weeks
Measured using digital weight scale
次要结局
- Time spent in sedentary activity using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Eating habits: sugary food score using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Alcohol consumption using recall questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Resting diastolic blood pressure(12 weeks (& 12 months - Hockey FIT group only))
- Weight loss (absolute and percentage)(12 months (Hockey FIT group only))
- Eating habits: Starting the conversation summary score using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Self-esteem summary score using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Negative affect score using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Health-related quality of life: VAS using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Body mass index using height and weight measures(12 weeks (& 12 months - Hockey FIT group only))
- Average steps per day using pedometer(12 weeks (& 12 months - Hockey FIT group only))
- Total physical activity in MET-minutes/week using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Eating habits: Fatty food score using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Eating habits: fruit and vegetable score using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Resting systolic blood pressure(12 weeks (& 12 months - Hockey FIT group only))
- Waist circumference(12 weeks (& 12 months - Hockey FIT group only))
- Health-related quality of life: Descriptive health state using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
- Positive affect score using questionnaire(12 weeks (& 12 months - Hockey FIT group only))
研究者
Robert Petrella
Dr. Robert J. Petrella
Western University, Canada