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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Hockey FIT Program (Immediate Delivery)
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Chronic disease, Men's health, Health promotion, Exercise, Healthy diet, Health Technology, Weight loss, Hockey

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Dort Federal Credit Union Event Center
  • Saginaw Valley State University
  • Veterans Memorial Coliseum
  • City of Brooks
  • Mount Royal University
  • University of Lethbridge
  • Downtown Medicine Hat YMCA
  • Northside Community Centre YMCA of Northern Alberta
  • Club XO Fitness
  • YMCA Kamloops
  • YMCA Okanagan
  • YMCA-YWCA Westhills
  • Langley Events Centre
  • Penticton Community Centre
  • YMCA of Northern BC
  • Shaw Centre
  • Avenir Centre
  • Afterburn Performance
  • YMCA of Halifax and Dartmouth
  • Barrie YMCA
  • YMCA of Central Eastern Ontario - Belleville Branch
  • Les Chater Family YMCA
  • YMCA of Kingston
  • A.R. Kaufman Family YMCA
  • Bostwick YMCA
  • Mississauga Burnhamthorpe Rd. YMCA Centre
  • YMCA of North Bay
  • Oshawa Mary Street YMCA Centre
  • YMCA of Owen Sound Grey Bruce
  • Balsillie Family YMCA
  • YMCA Jerry McCaw Family Centre
  • YMCA of Sault Ste Marie
  • Walker Family YMCA
  • YMCA Sudbury
  • YMCA at Central Park Athletics
  • University of Prince Edward Island
  • CBI Health Centre
  • University of Regina
  • YMCA of Saskatoon
  • Lt. Colonel Clifton Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hockey FIT Program (Immediate Delivery)

Wait-List Control (Delayed Delivery)

Arm Description

Hockey FIT Program: A gender-sensitized, weight loss and healthy lifestyle program that engages men using the power of being a sports fan.

No intervention for 12 months. After 12 months, Hockey FIT program is offered.

Outcomes

Primary Outcome Measures

Weight loss (absolute)
Measured using a digital weight scale (in kg)

Secondary Outcome Measures

Weight loss (absolute)
Measured using a digital weight scale (in kg)
Weight loss (percent change)
Measured using a digital weight scale (% change from baseline)
Predicted maximal oxygen uptake (VO2max)
Calculated from sub-maximal fitness test (in mL/kg/min)
Systolic blood pressure
Measured using an automated blood pressure monitor (in mm Hg)
Diastolic blood pressure
Measured using an automated blood pressure monitor (in mm Hg)
Body mass index
Calculated from weight (digital weight scale) and height (portable stadiometer) (in kg/m2)
Waist circumference
Measured using tape measure (in cm)
Glycated hemoglobin (A1c)
Measured using a point-of-care analyzer (%)
Daily steps
Measured using a waist-worn accelerometer-based step counter over 7 days (average steps/day)
Total physical activity MET-minutes/week
Measured using the International Physical Activity Questionnaire (IPAQ) - Short Form (sum of Walking + Moderate + Vigorous MET-minutes/week)
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)
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)
Walking MET-minutes/week
Measured using the International Physical Activity Questionnaire (IPAQ) - Short Version (calculated as 3.3 * walking minutes * walking days)
Total time spent sitting (on a week day)
Measured using the Marshall Questionnaire (in minutes)
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)
Fruit and vegetable intake
Measured using the Canadian Community Health Survey
Sweetened sugary beverages intake
Measured using the Behavioral Risk Factor Surveillance System Questionnaire
Total alcohol intake (weekly)
Measured using a 7-day recall diary
Smoking status
Measured using questions adapted from the Canadian Community Health Survey
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)
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)
Social connectedness score
Measured using the Duke Social Support Index (total score range, 11-33; higher values indicate higher levels of support)
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)

Full Information

First Posted
July 25, 2018
Last Updated
June 2, 2023
Sponsor
Western University, Canada
Collaborators
Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC)
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1. Study Identification

Unique Protocol Identification Number
NCT03636282
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
November 28, 2022 (Actual)
Study Completion Date
May 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
Collaborators
Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Chronic disease, Men's health, Health promotion, Exercise, Healthy diet, Health Technology, Weight loss, Hockey

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Trained assessors conducting measurements are not blinded to study allocation in all instances. When a trained assessor is not blinded, potential bias related to measurement of the primary outcome (weight) is being addressed by the requirement of photos of weight (measured via an electronic scale) being taken alongside the study measurement form (including study ID), at all follow-up time points. Furthermore, a study team member will verify that all weights recorded on the study measurement form match what is shown in the photo.
Allocation
Randomized
Enrollment
997 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hockey FIT Program (Immediate Delivery)
Arm Type
Experimental
Arm Description
Hockey FIT Program: A gender-sensitized, weight loss and healthy lifestyle program that engages men using the power of being a sports fan.
Arm Title
Wait-List Control (Delayed Delivery)
Arm Type
No Intervention
Arm Description
No intervention for 12 months. After 12 months, Hockey FIT program is offered.
Intervention Type
Behavioral
Intervention Name(s)
Hockey FIT Program (Immediate Delivery)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss (absolute)
Description
Measured using a digital weight scale (in kg)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Weight loss (absolute)
Description
Measured using a digital weight scale (in kg)
Time Frame
3 months
Title
Weight loss (percent change)
Description
Measured using a digital weight scale (% change from baseline)
Time Frame
3 months & 12 months
Title
Predicted maximal oxygen uptake (VO2max)
Description
Calculated from sub-maximal fitness test (in mL/kg/min)
Time Frame
3 months & 12 months
Title
Systolic blood pressure
Description
Measured using an automated blood pressure monitor (in mm Hg)
Time Frame
3 months & 12 months
Title
Diastolic blood pressure
Description
Measured using an automated blood pressure monitor (in mm Hg)
Time Frame
3 months & 12 months
Title
Body mass index
Description
Calculated from weight (digital weight scale) and height (portable stadiometer) (in kg/m2)
Time Frame
3 months & 12 months
Title
Waist circumference
Description
Measured using tape measure (in cm)
Time Frame
3 months & 12 months
Title
Glycated hemoglobin (A1c)
Description
Measured using a point-of-care analyzer (%)
Time Frame
3 months & 12 months
Title
Daily steps
Description
Measured using a waist-worn accelerometer-based step counter over 7 days (average steps/day)
Time Frame
3 months & 12 months
Title
Total physical activity MET-minutes/week
Description
Measured using the International Physical Activity Questionnaire (IPAQ) - Short Form (sum of Walking + Moderate + Vigorous MET-minutes/week)
Time Frame
3 months & 12 months
Title
Vigorous physical activity MET-minutes/week
Description
Measured using the International Physical Activity Questionnaire (IPAQ) - Short Form (calculated as 8.0 * vigorous-intensity activity minutes * vigorous-intensity days)
Time Frame
3 months & 12 months
Title
Moderate physical activity MET-minutes/week
Description
Measured using the International Physical Activity Questionnaire (IPAQ) - Short Form (calculated as 4.0 * moderate-intensity activity minutes * moderate-intensity days)
Time Frame
3 months & 12 months
Title
Walking MET-minutes/week
Description
Measured using the International Physical Activity Questionnaire (IPAQ) - Short Version (calculated as 3.3 * walking minutes * walking days)
Time Frame
3 months & 12 months
Title
Total time spent sitting (on a week day)
Description
Measured using the Marshall Questionnaire (in minutes)
Time Frame
3 months & 12 months
Title
Healthful eating score
Description
Measured using the Starting the Conversation (STC) Questionnaire (summary score of 8 items; score range, 0-16; lower score indicates more healthful eating)
Time Frame
3 months & 12 months
Title
Fruit and vegetable intake
Description
Measured using the Canadian Community Health Survey
Time Frame
3 months & 12 months
Title
Sweetened sugary beverages intake
Description
Measured using the Behavioral Risk Factor Surveillance System Questionnaire
Time Frame
3 months & 12 months
Title
Total alcohol intake (weekly)
Description
Measured using a 7-day recall diary
Time Frame
3 months & 12 months
Title
Smoking status
Description
Measured using questions adapted from the Canadian Community Health Survey
Time Frame
3 months & 12 months
Title
Overall self-rated health status
Description
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)
Time Frame
3 months & 12 months
Title
Well-being score
Description
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)
Time Frame
3 months & 12 months
Title
Social connectedness score
Description
Measured using the Duke Social Support Index (total score range, 11-33; higher values indicate higher levels of support)
Time Frame
3 months & 12 months
Title
Sleep quality global score
Description
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)
Time Frame
3 months & 12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Petrella, MD, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dort Federal Credit Union Event Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Saginaw Valley State University
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48710
Country
United States
Facility Name
Veterans Memorial Coliseum
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
City of Brooks
City
Brooks
State/Province
Alberta
Country
Canada
Facility Name
Mount Royal University
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Lethbridge
City
Lethbridge
State/Province
Alberta
ZIP/Postal Code
T1K 3M4
Country
Canada
Facility Name
Downtown Medicine Hat YMCA
City
Medicine Hat
State/Province
Alberta
ZIP/Postal Code
T1A 3A9
Country
Canada
Facility Name
Northside Community Centre YMCA of Northern Alberta
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P 3E9
Country
Canada
Facility Name
Club XO Fitness
City
Chilliwack
State/Province
British Columbia
ZIP/Postal Code
V2P 8G1
Country
Canada
Facility Name
YMCA Kamloops
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C 2L7
Country
Canada
Facility Name
YMCA Okanagan
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 6V8
Country
Canada
Facility Name
YMCA-YWCA Westhills
City
Langford
State/Province
British Columbia
ZIP/Postal Code
V9B 0S2
Country
Canada
Facility Name
Langley Events Centre
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V2Y 3J4
Country
Canada
Facility Name
Penticton Community Centre
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 7K9
Country
Canada
Facility Name
YMCA of Northern BC
City
Prince George
State/Province
British Columbia
ZIP/Postal Code
V2L 4V7
Country
Canada
Facility Name
Shaw Centre
City
Salmon Arm
State/Province
British Columbia
ZIP/Postal Code
V1E 2S4
Country
Canada
Facility Name
Avenir Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 0V2
Country
Canada
Facility Name
Afterburn Performance
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2J 1A2
Country
Canada
Facility Name
YMCA of Halifax and Dartmouth
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 1L2
Country
Canada
Facility Name
Barrie YMCA
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4N 1M7
Country
Canada
Facility Name
YMCA of Central Eastern Ontario - Belleville Branch
City
Belleville
State/Province
Ontario
ZIP/Postal Code
K8N 2G1
Country
Canada
Facility Name
Les Chater Family YMCA
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 2Z1
Country
Canada
Facility Name
YMCA of Kingston
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 4T9
Country
Canada
Facility Name
A.R. Kaufman Family YMCA
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 3C5
Country
Canada
Facility Name
Bostwick YMCA
City
London
State/Province
Ontario
ZIP/Postal Code
N6K 3X4
Country
Canada
Facility Name
Mississauga Burnhamthorpe Rd. YMCA Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 3R2
Country
Canada
Facility Name
YMCA of North Bay
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 6G2
Country
Canada
Facility Name
Oshawa Mary Street YMCA Centre
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 8C1
Country
Canada
Facility Name
YMCA of Owen Sound Grey Bruce
City
Owen Sound
State/Province
Ontario
ZIP/Postal Code
N4K 0C6
Country
Canada
Facility Name
Balsillie Family YMCA
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 3H8
Country
Canada
Facility Name
YMCA Jerry McCaw Family Centre
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7S 6G5
Country
Canada
Facility Name
YMCA of Sault Ste Marie
City
Sault Ste Marie
State/Province
Ontario
ZIP/Postal Code
P6B 1Y3
Country
Canada
Facility Name
Walker Family YMCA
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2N 7P9
Country
Canada
Facility Name
YMCA Sudbury
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 3M7
Country
Canada
Facility Name
YMCA at Central Park Athletics
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N7G 4H5
Country
Canada
Facility Name
University of Prince Edward Island
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 4P3
Country
Canada
Facility Name
CBI Health Centre
City
Prince Albert
State/Province
Saskatchewan
ZIP/Postal Code
S6W 1A1
Country
Canada
Facility Name
University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
Facility Name
YMCA of Saskatoon
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0C7
Country
Canada
Facility Name
Lt. Colonel Clifton Centre
City
Swift Current
State/Province
Saskatchewan
ZIP/Postal Code
S9H 3W1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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