Hockey Fans in Training (Hockey FIT): A Pragmatic Cluster Randomized Controlled Trial to Improve Men's Health Through the Power of Sport
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 997
- 试验地点
- 40
- 主要终点
- Weight loss (absolute)
研究概览
简要总结
Hockey Fans in Training (Hockey FIT) is a 12-month (3-month active phase and 9-month minimally-supported phase) weight loss and healthy lifestyle program for middle-aged, male hockey fans with overweight or obesity, delivered by trained coaches in collaboration with major junior or professional hockey teams and implementation partners (e.g., YMCAs, local fitness facilities, and universities) in Canada and the United States.
In the proposed study, a minimum of 32 sites (affiliated with hockey teams and local implementation partners) will be randomly assigned to either immediate delivery (Hockey FIT program) or delayed delivery (wait-list control). At each site, male hockey fans at risk for chronic diseases will be recruited to take part in the study (note: the goal is to recruit approximately 40 men/site). Sites assigned to the delayed delivery group will offer the Hockey FIT program to their enrolled participants after 12 months.
Through the Hockey FIT program, the investigators aim to promote weight loss, increase physical activity levels, and improve other health measures through a cost-effective solution that is acceptable and appealing to men who have overweight or obesity.
详细描述
The overall goal of this study is to reduce preventable chronic diseases in men by improving health behaviours and health indicators. To achieve this goal, following a successful pilot study providing strong evidence to proceed with a definitive trial, the investigators are conducting a pragmatic, cluster randomized controlled trial (RCT) of the Hockey FIT program.
The primary specific aim is to conduct an outcome evaluation to evaluate the effectiveness of Hockey FIT in middle-aged men who have overweight or obesity. Specifically, the investigators will: examine whether Hockey FIT (vs. wait-list control) leads to: greater weight loss at 12 months (primary outcome), as well as improved health behaviours (physical activity; sedentary time; eating habits) and health indicators (physiological measures; health & psychosocial measures) at 3 and 12 months.
Following the pilot study, the investigators will use the affiliation of being a fan of hockey as a powerful draw to engage men. Sites will be selected based on availability of both a major junior (or professional) hockey team and an implementation partner (e.g., YMCA branch, fitness facility, University) located in the city. A minimum of 32 sites in Canada and the United States will be randomized to the intervention (Hockey FIT program: immediately delivery) or comparator (wait-list control: delayed delivery); at each site, men will be recruited to participate (with the goal of recruiting approximately 40 men/site). Intervention sites will begin Hockey FIT immediately while comparator sites will offer Hockey FIT after a 12-month delay. The measurement sessions involving both groups will take place at 0 (baseline), 3 and 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 (Outcomes Assessor)
盲法说明
Trained assessors conducting measurements are not blinded to study allocation in all instances. When a trained assessor is not blinded, potential bias related to measurement of the primary outcome (weight) is being addressed by the requirement of photos of weight (measured via an electronic scale) being taken alongside the study measurement form (including study ID), at all follow-up time points. Furthermore, a study team member will verify that all weights recorded on the study measurement form match what is shown in the photo.
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
- •Between 35 and 65 years of age;
- •Objectively-measured body-mass index of at least 27 kg/m2
- •Deemed safe to participate in physical activity [i.e., clear the 2018 Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) or receive written clearance from a health care provider].
排除标准
- •1) Advised by a health care provider to not participate in the program
研究组 & 干预措施
Hockey FIT Program (Immediate Delivery)
Hockey FIT Program: A gender-sensitized, weight loss and healthy lifestyle program that engages men using the power of being a sports fan.
干预措施: Hockey FIT Program (Immediate Delivery) (Behavioral)
Wait-List Control (Delayed Delivery)
No intervention for 12 months. After 12 months, Hockey FIT program is offered.
结局指标
主要结局
Weight loss (absolute)
时间窗: 12 months
Measured using a digital weight scale (in kg)
次要结局
- Vigorous physical activity MET-minutes/week(3 months & 12 months)
- Moderate physical activity MET-minutes/week(3 months & 12 months)
- Total physical activity MET-minutes/week(3 months & 12 months)
- Weight loss (percent change)(3 months & 12 months)
- Body mass index(3 months & 12 months)
- Daily steps(3 months & 12 months)
- Sweetened sugary beverages intake(3 months & 12 months)
- Waist circumference(3 months & 12 months)
- Walking MET-minutes/week(3 months & 12 months)
- Total time spent sitting (on a week day)(3 months & 12 months)
- Weight loss (absolute)(3 months)
- Predicted maximal oxygen uptake (VO2max)(3 months & 12 months)
- Systolic blood pressure(3 months & 12 months)
- Diastolic blood pressure(3 months & 12 months)
- Glycated hemoglobin (A1c)(3 months & 12 months)
- Healthful eating score(3 months & 12 months)
- Fruit and vegetable intake(3 months & 12 months)
- Smoking status(3 months & 12 months)
- Overall self-rated health status(3 months & 12 months)
- Well-being score(3 months & 12 months)
- Social connectedness score(3 months & 12 months)
- Sleep quality global score(3 months & 12 months)
- Total alcohol intake (weekly)(3 months & 12 months)
研究者
Robert Petrella
Professor
Western University, Canada