Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Hockey FIT Program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hockey FIT program<br>12-week active phase - exercise and healthy living program (1x/week; 90 minutes/session); 40-week maintenance phase (individualized approach) | Behavioral: Hockey FIT Program<br>* 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<br>* Other names: Hockey FIT;|
| No Intervention: Usual-care wait-list control<br>No active intervention (usual care) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss (absolute and percentage) | Measured using digital weight scale | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss (absolute and percentage) | Measured using digital weight scale | 12 months (Hockey FIT group only) | 
| Average steps per day using pedometer | Measured over a 7-day period using pedometers | 12 weeks (& 12 months - Hockey FIT group only) | 
| Total physical activity in MET-minutes/week using questionnaire | International Physical Activity Questionnaire - Short Version | 12 weeks (& 12 months - Hockey FIT group only) | 
| Time spent in sedentary activity using questionnaire | Measured by the International Physical Activity Questionnaire - Short Version | 12 weeks (& 12 months - Hockey FIT group only) | 
| Eating habits: Fatty food score using questionnaire | Measured by the modified Dietary Instrument for Nutrition Education | 12 weeks (& 12 months - Hockey FIT group only) | 
| Eating habits: fruit and vegetable score using questionnaire | Measured by the modified Dietary Instrument for Nutrition Education | 12 weeks (& 12 months - Hockey FIT group only) | 
| Eating habits: sugary food score using questionnaire | Measured by the modified Dietary Instrument for Nutrition Education | 12 weeks (& 12 months - Hockey FIT group only) | 
| Eating habits: Starting the conversation summary score using questionnaire | Measured by Starting the Conversation Dietary Assessment Tool | 12 weeks (& 12 months - Hockey FIT group only) | 
| Alcohol consumption using recall questionnaire | Measured by a 7-day alcohol recall (number of drinks in last 7 days) | 12 weeks (& 12 months - Hockey FIT group only) | 
| Resting systolic blood pressure | Measured using automated blood pressure monitor | 12 weeks (& 12 months - Hockey FIT group only) | 
| Resting diastolic blood pressure | Measured using automated blood pressure monitor | 12 weeks (& 12 months - Hockey FIT group only) | 
| Waist circumference | Measured using tape measure | 12 weeks (& 12 months - Hockey FIT group only) | 
| Body mass index using height and weight measures | Height will be measured with a portable stadiometer; weight will be measured with a digital weight scale | 12 weeks (& 12 months - Hockey FIT group only) | 
| Self-esteem summary score using questionnaire | Summary score from Rosenberg Self Esteem Scale | 12 weeks (& 12 months - Hockey FIT group only) | 
| Positive affect score using questionnaire | Measured by the International Positive and Negative Affect Schedule Short Form | 12 weeks (& 12 months - Hockey FIT group only) | 
| Negative affect score using questionnaire | Measured by the International Positive and Negative Affect Schedule Short Form | 12 weeks (& 12 months - Hockey FIT group only) | 
| Health-related quality of life: Descriptive health state using questionnaire | EQ-5D index measured by EQ-5D-3L | 12 weeks (& 12 months - Hockey FIT group only) | 
| Health-related quality of life: VAS using questionnaire | EQ VAS measured by EQ-5D-3L | 12 weeks (& 12 months - Hockey FIT group only) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Disease, Lifestyle Intervention, Health Promotion, Sport Mentorship, Men, Health Technology, Prevention, Exercise, Diet