- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03636282
Hockey Fans in Training (Hockey FIT): Improving Men's Health Through the Power of Sport
Hockey Fans in Training (Hockey FIT): A Pragmatic Cluster Randomized Controlled Trial to Improve Men's Health Through the Power of Sport
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Brooks, Alberta, Canada
- City of Brooks
-
Calgary, Alberta, Canada
- Mount Royal University
-
Lethbridge, Alberta, Canada, T1K 3M4
- University of Lethbridge
-
Medicine Hat, Alberta, Canada, T1A 3A9
- Downtown Medicine Hat YMCA
-
Red Deer, Alberta, Canada, T4P 3E9
- Northside Community Centre YMCA of Northern Alberta
-
-
British Columbia
-
Chilliwack, British Columbia, Canada, V2P 8G1
- Club XO Fitness
-
Kamloops, British Columbia, Canada, V2C 2L7
- YMCA Kamloops
-
Kelowna, British Columbia, Canada, V1Y 6V8
- YMCA Okanagan
-
Langford, British Columbia, Canada, V9B 0S2
- YMCA-YWCA Westhills
-
Langley, British Columbia, Canada, V2Y 3J4
- Langley Events Centre
-
Penticton, British Columbia, Canada, V2A 7K9
- Penticton Community Centre
-
Prince George, British Columbia, Canada, V2L 4V7
- YMCA of Northern BC
-
Salmon Arm, British Columbia, Canada, V1E 2S4
- Shaw Centre
-
-
New Brunswick
-
Moncton, New Brunswick, Canada, E1C 0V2
- Avenir Centre
-
Saint John, New Brunswick, Canada, E2J 1A2
- Afterburn Performance
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3J 1L2
- YMCA of Halifax and Dartmouth
-
-
Ontario
-
Barrie, Ontario, Canada, L4N 1M7
- Barrie YMCA
-
Belleville, Ontario, Canada, K8N 2G1
- YMCA of Central Eastern Ontario - Belleville Branch
-
Hamilton, Ontario, Canada, L8P 2Z1
- Les Chater Family YMCA
-
Kingston, Ontario, Canada, K7L 4T9
- YMCA of Kingston
-
Kitchener, Ontario, Canada, N2G 3C5
- A.R. Kaufman Family YMCA
-
London, Ontario, Canada, N6K 3X4
- Bostwick YMCA
-
Mississauga, Ontario, Canada, L5B 3R2
- Mississauga Burnhamthorpe Rd. YMCA Centre
-
North Bay, Ontario, Canada, P1B 6G2
- YMCA of North Bay
-
Oshawa, Ontario, Canada, L1G 8C1
- Oshawa Mary Street YMCA Centre
-
Owen Sound, Ontario, Canada, N4K 0C6
- YMCA of Owen Sound Grey Bruce
-
Peterborough, Ontario, Canada, K9J 3H8
- Balsillie Family YMCA
-
Sarnia, Ontario, Canada, N7S 6G5
- YMCA Jerry McCaw Family Centre
-
Sault Ste Marie, Ontario, Canada, P6B 1Y3
- YMCA of Sault Ste Marie
-
St. Catharines, Ontario, Canada, L2N 7P9
- Walker Family YMCA
-
Sudbury, Ontario, Canada, P3E 3M7
- YMCA Sudbury
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Windsor, Ontario, Canada, N7G 4H5
- YMCA at Central Park Athletics
-
-
Prince Edward Island
-
Charlottetown, Prince Edward Island, Canada, C1A 4P3
- University of Prince Edward Island
-
-
Saskatchewan
-
Prince Albert, Saskatchewan, Canada, S6W 1A1
- CBI Health Centre
-
Regina, Saskatchewan, Canada, S4S 0A2
- University of Regina
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Saskatoon, Saskatchewan, Canada, S7K 0C7
- YMCA of Saskatoon
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Swift Current, Saskatchewan, Canada, S9H 3W1
- Lt. Colonel Clifton Centre
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-
-
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Michigan
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Flint, Michigan, United States, 48503
- Dort Federal Credit Union Event Center
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Saginaw, Michigan, United States, 48710
- Saginaw Valley State University
-
-
Oregon
-
Portland, Oregon, United States, 97227
- Veterans Memorial Coliseum
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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. |
|
No Intervention: Wait-List Control (Delayed Delivery)
No intervention for 12 months.
After 12 months, Hockey FIT program is offered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss (absolute)
Time Frame: 12 months
|
Measured using a digital weight scale (in kg)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss (absolute)
Time Frame: 3 months
|
Measured using a digital weight scale (in kg)
|
3 months
|
|
Weight loss (percent change)
Time Frame: 3 months & 12 months
|
Measured using a digital weight scale (% change from baseline)
|
3 months & 12 months
|
|
Predicted maximal oxygen uptake (VO2max)
Time Frame: 3 months & 12 months
|
Calculated from sub-maximal fitness test (in mL/kg/min)
|
3 months & 12 months
|
|
Systolic blood pressure
Time Frame: 3 months & 12 months
|
Measured using an automated blood pressure monitor (in mm Hg)
|
3 months & 12 months
|
|
Diastolic blood pressure
Time Frame: 3 months & 12 months
|
Measured using an automated blood pressure monitor (in mm Hg)
|
3 months & 12 months
|
|
Body mass index
Time Frame: 3 months & 12 months
|
Calculated from weight (digital weight scale) and height (portable stadiometer) (in kg/m2)
|
3 months & 12 months
|
|
Waist circumference
Time Frame: 3 months & 12 months
|
Measured using tape measure (in cm)
|
3 months & 12 months
|
|
Glycated hemoglobin (A1c)
Time Frame: 3 months & 12 months
|
Measured using a point-of-care analyzer (%)
|
3 months & 12 months
|
|
Daily steps
Time Frame: 3 months & 12 months
|
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
Time Frame: 3 months & 12 months
|
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
Time Frame: 3 months & 12 months
|
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
Time Frame: 3 months & 12 months
|
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
Time Frame: 3 months & 12 months
|
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)
Time Frame: 3 months & 12 months
|
Measured using the Marshall Questionnaire (in minutes)
|
3 months & 12 months
|
|
Healthful eating score
Time Frame: 3 months & 12 months
|
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
Time Frame: 3 months & 12 months
|
Measured using the Canadian Community Health Survey
|
3 months & 12 months
|
|
Sweetened sugary beverages intake
Time Frame: 3 months & 12 months
|
Measured using the Behavioral Risk Factor Surveillance System Questionnaire
|
3 months & 12 months
|
|
Total alcohol intake (weekly)
Time Frame: 3 months & 12 months
|
Measured using a 7-day recall diary
|
3 months & 12 months
|
|
Smoking status
Time Frame: 3 months & 12 months
|
Measured using questions adapted from the Canadian Community Health Survey
|
3 months & 12 months
|
|
Overall self-rated health status
Time Frame: 3 months & 12 months
|
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
Time Frame: 3 months & 12 months
|
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
Time Frame: 3 months & 12 months
|
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
Time Frame: 3 months & 12 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Petrella, MD, PhD, Western University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111881
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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