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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636282
• Other study ID #: 111881
• Status: Completed
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: May 3, 2023

Study information

• Verified date: June 2023
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 997
• Est. completion date: May 3, 2023
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male;

2. Between 35 and 65 years of age;

3. Objectively-measured body-mass index of at least 27 kg/m2

4. 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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Hockey FIT Program (Immediate Delivery)
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.

Locations

Country	Name	City	State
Canada	Barrie YMCA	Barrie	Ontario
Canada	YMCA of Central Eastern Ontario - Belleville Branch	Belleville	Ontario
Canada	City of Brooks	Brooks	Alberta
Canada	Mount Royal University	Calgary	Alberta
Canada	University of Prince Edward Island	Charlottetown	Prince Edward Island
Canada	Club XO Fitness	Chilliwack	British Columbia
Canada	YMCA of Halifax and Dartmouth	Halifax	Nova Scotia
Canada	Les Chater Family YMCA	Hamilton	Ontario
Canada	YMCA Kamloops	Kamloops	British Columbia
Canada	YMCA Okanagan	Kelowna	British Columbia
Canada	YMCA of Kingston	Kingston	Ontario
Canada	A.R. Kaufman Family YMCA	Kitchener	Ontario
Canada	YMCA-YWCA Westhills	Langford	British Columbia
Canada	Langley Events Centre	Langley	British Columbia
Canada	University of Lethbridge	Lethbridge	Alberta
Canada	Bostwick YMCA	London	Ontario
Canada	Downtown Medicine Hat YMCA	Medicine Hat	Alberta
Canada	Mississauga Burnhamthorpe Rd. YMCA Centre	Mississauga	Ontario
Canada	Avenir Centre	Moncton	New Brunswick
Canada	YMCA of North Bay	North Bay	Ontario
Canada	Oshawa Mary Street YMCA Centre	Oshawa	Ontario
Canada	YMCA of Owen Sound Grey Bruce	Owen Sound	Ontario
Canada	Penticton Community Centre	Penticton	British Columbia
Canada	Balsillie Family YMCA	Peterborough	Ontario
Canada	CBI Health Centre	Prince Albert	Saskatchewan
Canada	YMCA of Northern BC	Prince George	British Columbia
Canada	Northside Community Centre YMCA of Northern Alberta	Red Deer	Alberta
Canada	University of Regina	Regina	Saskatchewan
Canada	Afterburn Performance	Saint John	New Brunswick
Canada	Shaw Centre	Salmon Arm	British Columbia
Canada	YMCA Jerry McCaw Family Centre	Sarnia	Ontario
Canada	YMCA of Saskatoon	Saskatoon	Saskatchewan
Canada	YMCA of Sault Ste Marie	Sault Ste Marie	Ontario
Canada	Walker Family YMCA	St. Catharines	Ontario
Canada	YMCA Sudbury	Sudbury	Ontario
Canada	Lt. Colonel Clifton Centre	Swift Current	Saskatchewan
Canada	YMCA at Central Park Athletics	Windsor	Ontario
United States	Dort Federal Credit Union Event Center	Flint	Michigan
United States	Veterans Memorial Coliseum	Portland	Oregon
United States	Saginaw Valley State University	Saginaw	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Western University, Canada	Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss (absolute)	Measured using a digital weight scale (in kg)	12 months
Secondary	Weight loss (absolute)	Measured using a digital weight scale (in kg)	3 months
Secondary	Weight loss (percent change)	Measured using a digital weight scale (% change from baseline)	3 months & 12 months
Secondary	Predicted maximal oxygen uptake (VO2max)	Calculated from sub-maximal fitness test (in mL/kg/min)	3 months & 12 months
Secondary	Systolic blood pressure	Measured using an automated blood pressure monitor (in mm Hg)	3 months & 12 months
Secondary	Diastolic blood pressure	Measured using an automated blood pressure monitor (in mm Hg)	3 months & 12 months
Secondary	Body mass index	Calculated from weight (digital weight scale) and height (portable stadiometer) (in kg/m2)	3 months & 12 months
Secondary	Waist circumference	Measured using tape measure (in cm)	3 months & 12 months
Secondary	Glycated hemoglobin (A1c)	Measured using a point-of-care analyzer (%)	3 months & 12 months
Secondary	Daily steps	Measured using a waist-worn accelerometer-based step counter over 7 days (average steps/day)	3 months & 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total time spent sitting (on a week day)	Measured using the Marshall Questionnaire (in minutes)	3 months & 12 months
Secondary	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
Secondary	Fruit and vegetable intake	Measured using the Canadian Community Health Survey	3 months & 12 months
Secondary	Sweetened sugary beverages intake	Measured using the Behavioral Risk Factor Surveillance System Questionnaire	3 months & 12 months
Secondary	Total alcohol intake (weekly)	Measured using a 7-day recall diary	3 months & 12 months
Secondary	Smoking status	Measured using questions adapted from the Canadian Community Health Survey	3 months & 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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