Hockey Fans in Training (Hockey FIT): Improving Men's Health Through the Power of Sport

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hockey Fans in Training (Hockey FIT): A Pragmatic Cluster Randomized Controlled Trial to Improve Men's Health Through the Power of Sport

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Hockey FIT Program (Immediate Delivery)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male; 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]. Exclusion Criteria: 1) Advised by a health care provider to not participate in the program

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic cluster randomized controlled trial with 2 arms: intervention (immediate delivery of Hockey FIT program) and comparator (wait-list control/delayed delivery of Hockey FIT program)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hockey FIT Program (Immediate Delivery)<br>Hockey FIT Program: A gender-sensitized, weight loss and healthy lifestyle program that engages men using the power of being a sports fan. | Behavioral: Hockey FIT Program (Immediate Delivery)<br>* Hockey FIT is comprised of a 3-Month Active Phase and a 9-Month Minimally-Supported Phase. Active Phase: 12 weekly, 90-minute group-based sessions consisting of classroom-based education and exercise. Outside of sessions, participants follow their individualized lifestyle prescriptions for healthy eating, physical activity (steps), and exercise. Participants are encouraged to regularly use health technology support tools customized to Hockey FIT. Minimally-supported phase: Participants are encouraged to continue with their healthy lifestyle behaviour changes and to regularly use the health technology support tools.<br>|
| No Intervention: Wait-List Control (Delayed Delivery)<br>No intervention for 12 months. After 12 months, Hockey FIT program is offered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss (absolute) | Measured using a digital weight scale (in kg) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss (absolute) | Measured using a digital weight scale (in kg) | 3 months | 
| Weight loss (percent change) | Measured using a digital weight scale (% change from baseline) | 3 months & 12 months | 
| Predicted maximal oxygen uptake (VO2max) | Calculated from sub-maximal fitness test (in mL/kg/min) | 3 months & 12 months | 
| Systolic blood pressure | Measured using an automated blood pressure monitor (in mm Hg) | 3 months & 12 months | 
| Diastolic blood pressure | Measured using an automated blood pressure monitor (in mm Hg) | 3 months & 12 months | 
| Body mass index | Calculated from weight (digital weight scale) and height (portable stadiometer) (in kg/m2) | 3 months & 12 months | 
| Waist circumference | Measured using tape measure (in cm) | 3 months & 12 months | 
| Glycated hemoglobin (A1c) | Measured using a point-of-care analyzer (%) | 3 months & 12 months | 
| Daily steps | Measured using a waist-worn accelerometer-based step counter over 7 days (average steps/day) | 3 months & 12 months | 
| Total physical activity MET-minutes/week | Measured using the International Physical Activity Questionnaire (IPAQ) - Short Form (sum of Walking + Moderate + Vigorous MET-minutes/week) | 3 months & 12 months | 
| Vigorous physical activity MET-minutes/week | Measured using the International Physical Activity Questionnaire (IPAQ) - Short Form (calculated as 8.0 * vigorous-intensity activity minutes * vigorous-intensity days) | 3 months & 12 months | 
| Moderate physical activity MET-minutes/week | Measured using the International Physical Activity Questionnaire (IPAQ) - Short Form (calculated as 4.0 * moderate-intensity activity minutes * moderate-intensity days) | 3 months & 12 months | 
| Walking MET-minutes/week | Measured using the International Physical Activity Questionnaire (IPAQ) - Short Version (calculated as 3.3 * walking minutes * walking days) | 3 months & 12 months | 
| Total time spent sitting (on a week day) | Measured using the Marshall Questionnaire (in minutes) | 3 months & 12 months | 
| Healthful eating score | Measured using the Starting the Conversation (STC) Questionnaire (summary score of 8 items; score range, 0-16; lower score indicates more healthful eating) | 3 months & 12 months | 
| Fruit and vegetable intake | Measured using the Canadian Community Health Survey | 3 months & 12 months | 
| Sweetened sugary beverages intake | Measured using the Behavioral Risk Factor Surveillance System Questionnaire | 3 months & 12 months | 
| Total alcohol intake (weekly) | Measured using a 7-day recall diary | 3 months & 12 months | 
| Smoking status | Measured using questions adapted from the Canadian Community Health Survey | 3 months & 12 months | 
| Overall self-rated health status | Measured using the EQ-5D 5 level version, specifically using the EQ visual analogue scale (EQ-VAS; range, 0-100; higher score indicates better self-rated health where 100 = best imaginable health state) | 3 months & 12 months | 
| Well-being score | Measured using the World Health Organization (Five) Well-Being Index (raw score is calculated from totalling 5 items and is converted to a percentage score when multiplied by 4; percentage score range, 0-100; higher score indicates better better quality of life where 100 represents best possible quality of life) | 3 months & 12 months | 
| Social connectedness score | Measured using the Duke Social Support Index (total score range, 11-33; higher values indicate higher levels of support) | 3 months & 12 months | 
| Sleep quality global score | Measured using the Pittsburgh Sleep Quality Index (calculated by totalling the sum of 7 component scores; score range, 0-21; higher scores indicate worse sleep quality) | 3 months & 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic disease, Men's health, Health promotion, Exercise, Healthy diet, Health Technology, Weight loss, Hockey