Clinical trial NCT03636282: Hockey Fans in Training (Hockey FIT): Improving Men's Health Through the Power of Sport
Official title: Hockey Fans in Training (Hockey FIT): A Pragmatic Cluster Randomized Controlled Trial to Improve Men's Health Through the Power of Sport
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Chronic disease
Men's health
Health promotion
Exercise
Healthy diet
Health Technology
Weight loss
Hockey
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Public Health Agency of Canada (PHAC)
First posted: 2018-08-17
Enrollment: 997
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss (absolute)
timeFrame: 12 months
Secondary outcomes:
measure: Weight loss (absolute)
timeFrame: 3 months
measure: Weight loss (percent change)
timeFrame: 3 months & 12 months
measure: Predicted maximal oxygen uptake (VO2max)
timeFrame: 3 months & 12 months
measure: Systolic blood pressure
timeFrame: 3 months & 12 months
measure: Diastolic blood pressure
timeFrame: 3 months & 12 months
measure: Body mass index
timeFrame: 3 months & 12 months
measure: Waist circumference
timeFrame: 3 months & 12 months
measure: Glycated hemoglobin (A1c)
timeFrame: 3 months & 12 months
measure: Daily steps
timeFrame: 3 months & 12 months
measure: Total physical activity MET-minutes/week
timeFrame: 3 months & 12 months
measure: Vigorous physical activity MET-minutes/week
timeFrame: 3 months & 12 months
measure: Moderate physical activity MET-minutes/week
timeFrame: 3 months & 12 months
measure: Walking MET-minutes/week
timeFrame: 3 months & 12 months
measure: Total time spent sitting (on a week day)
timeFrame: 3 months & 12 months
measure: Healthful eating score
timeFrame: 3 months & 12 months
measure: Fruit and vegetable intake
timeFrame: 3 months & 12 months
measure: Sweetened sugary beverages intake
timeFrame: 3 months & 12 months
measure: Total alcohol intake (weekly)
timeFrame: 3 months & 12 months
measure: Smoking status
timeFrame: 3 months & 12 months
measure: Overall self-rated health status
timeFrame: 3 months & 12 months
measure: Well-being score
timeFrame: 3 months & 12 months
measure: Social connectedness score
timeFrame: 3 months & 12 months
measure: Sleep quality global score
timeFrame: 3 months & 12 months
Other outcomes:
Locations:
city: Flint
country: United States
facility: Dort Federal Credit Union Event Center
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley State University
state: Michigan
city: Portland
country: United States
facility: Veterans Memorial Coliseum
state: Oregon
city: Brooks
country: Canada
facility: City of Brooks
state: Alberta
city: Calgary
country: Canada
facility: Mount Royal University
state: Alberta
city: Lethbridge
country: Canada
facility: University of Lethbridge
state: Alberta
city: Medicine Hat
country: Canada
facility: Downtown Medicine Hat YMCA
state: Alberta
city: Red Deer
country: Canada
facility: Northside Community Centre YMCA of Northern Alberta
state: Alberta
city: Chilliwack
country: Canada
facility: Club XO Fitness
state: British Columbia
city: Kamloops
country: Canada
facility: YMCA Kamloops
state: British Columbia
city: Kelowna
country: Canada
facility: YMCA Okanagan
state: British Columbia
city: Langford
country: Canada
facility: YMCA-YWCA Westhills
state: British Columbia
city: Langley
country: Canada
facility: Langley Events Centre
state: British Columbia
city: Penticton
country: Canada
facility: Penticton Community Centre
state: British Columbia
city: Prince George
country: Canada
facility: YMCA of Northern BC
state: British Columbia
city: Salmon Arm
country: Canada
facility: Shaw Centre
state: British Columbia
city: Moncton
country: Canada
facility: Avenir Centre
state: New Brunswick
city: Saint John
country: Canada
facility: Afterburn Performance
state: New Brunswick
city: Halifax
country: Canada
facility: YMCA of Halifax and Dartmouth
state: Nova Scotia
city: Barrie
country: Canada
facility: Barrie YMCA
state: Ontario
city: Belleville
country: Canada
facility: YMCA of Central Eastern Ontario - Belleville Branch
state: Ontario
city: Hamilton
country: Canada
facility: Les Chater Family YMCA
state: Ontario
city: Kingston
country: Canada
facility: YMCA of Kingston
state: Ontario
city: Kitchener
country: Canada
facility: A.R. Kaufman Family YMCA
state: Ontario
city: London
country: Canada
facility: Bostwick YMCA
state: Ontario
city: Mississauga
country: Canada
facility: Mississauga Burnhamthorpe Rd. YMCA Centre
state: Ontario
city: North Bay
country: Canada
facility: YMCA of North Bay
state: Ontario
city: Oshawa
country: Canada
facility: Oshawa Mary Street YMCA Centre
state: Ontario
city: Owen Sound
country: Canada
facility: YMCA of Owen Sound Grey Bruce
state: Ontario
city: Peterborough
country: Canada
facility: Balsillie Family YMCA
state: Ontario
city: Sarnia
country: Canada
facility: YMCA Jerry McCaw Family Centre
state: Ontario
city: Sault Ste Marie
country: Canada
facility: YMCA of Sault Ste Marie
state: Ontario
city: St. Catharines
country: Canada
facility: Walker Family YMCA
state: Ontario
city: Sudbury
country: Canada
facility: YMCA Sudbury
state: Ontario
city: Windsor
country: Canada
facility: YMCA at Central Park Athletics
state: Ontario
city: Charlottetown
country: Canada
facility: University of Prince Edward Island
state: Prince Edward Island
city: Prince Albert
country: Canada
facility: CBI Health Centre
state: Saskatchewan
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
city: Saskatoon
country: Canada
facility: YMCA of Saskatoon
state: Saskatchewan
city: Swift Current
country: Canada
facility: Lt. Colonel Clifton Centre
state: Saskatchewan
Study officials:
affiliation: Western University
name: Robert Petrella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: