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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hockey FIT Program
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, Lifestyle Intervention, Health Promotion, Sport Mentorship, Men, Health Technology, Prevention, Exercise, Diet

Eligibility Criteria

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

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

Sites / Locations

  • London Knights
  • Sarnia Sting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hockey FIT program

Usual-care wait-list control

Arm Description

12-week active phase - exercise and healthy living program (1x/week; 90 minutes/session); 40-week maintenance phase (individualized approach)

No active intervention (usual care)

Outcomes

Primary Outcome Measures

Weight loss (absolute and percentage)
Measured using digital weight scale

Secondary Outcome Measures

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

Full Information

First Posted
February 26, 2015
Last Updated
September 27, 2017
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02396524
Brief Title
Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Chronic Disease, Lifestyle Intervention, Health Promotion, Sport Mentorship, Men, Health Technology, Prevention, Exercise, Diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hockey FIT program
Arm Type
Experimental
Arm Description
12-week active phase - exercise and healthy living program (1x/week; 90 minutes/session); 40-week maintenance phase (individualized approach)
Arm Title
Usual-care wait-list control
Arm Type
No Intervention
Arm Description
No active intervention (usual care)
Intervention Type
Behavioral
Intervention Name(s)
Hockey FIT Program
Other Intervention Name(s)
Hockey Fans in Training Program, Hockey Fans in Training, Hockey FIT
Intervention Description
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
Primary Outcome Measure Information:
Title
Weight loss (absolute and percentage)
Description
Measured using digital weight scale
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Weight loss (absolute and percentage)
Description
Measured using digital weight scale
Time Frame
12 months (Hockey FIT group only)
Title
Average steps per day using pedometer
Description
Measured over a 7-day period using pedometers
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Total physical activity in MET-minutes/week using questionnaire
Description
International Physical Activity Questionnaire - Short Version
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Time spent in sedentary activity using questionnaire
Description
Measured by the International Physical Activity Questionnaire - Short Version
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Eating habits: Fatty food score using questionnaire
Description
Measured by the modified Dietary Instrument for Nutrition Education
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Eating habits: fruit and vegetable score using questionnaire
Description
Measured by the modified Dietary Instrument for Nutrition Education
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Eating habits: sugary food score using questionnaire
Description
Measured by the modified Dietary Instrument for Nutrition Education
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Eating habits: Starting the conversation summary score using questionnaire
Description
Measured by Starting the Conversation Dietary Assessment Tool
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Alcohol consumption using recall questionnaire
Description
Measured by a 7-day alcohol recall (number of drinks in last 7 days)
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Resting systolic blood pressure
Description
Measured using automated blood pressure monitor
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Resting diastolic blood pressure
Description
Measured using automated blood pressure monitor
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Waist circumference
Description
Measured using tape measure
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Body mass index using height and weight measures
Description
Height will be measured with a portable stadiometer; weight will be measured with a digital weight scale
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Self-esteem summary score using questionnaire
Description
Summary score from Rosenberg Self Esteem Scale
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Positive affect score using questionnaire
Description
Measured by the International Positive and Negative Affect Schedule Short Form
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Negative affect score using questionnaire
Description
Measured by the International Positive and Negative Affect Schedule Short Form
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Health-related quality of life: Descriptive health state using questionnaire
Description
EQ-5D index measured by EQ-5D-3L
Time Frame
12 weeks (& 12 months - Hockey FIT group only)
Title
Health-related quality of life: VAS using questionnaire
Description
EQ VAS measured by EQ-5D-3L
Time Frame
12 weeks (& 12 months - Hockey FIT group only)

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Petrella, MD, PhD
Organizational Affiliation
University of Western Ontario, Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Knights
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 6K1
Country
Canada
Facility Name
Sarnia Sting
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7S 6K4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29183291
Citation
Blunt W, Gill DP, Sibbald SL, Riggin B, Pulford RW, Scott R, Danylchuk K, Gray CM, Wyke S, Bunn C, Petrella RJ. Optimization of the Hockey Fans in Training (Hockey FIT) weight loss and healthy lifestyle program for male hockey fans. BMC Public Health. 2017 Nov 28;17(1):916. doi: 10.1186/s12889-017-4926-z.
Results Reference
derived
PubMed Identifier
27756351
Citation
Gill DP, Blunt W, De Cruz A, Riggin B, Hunt K, Zou G, Sibbald S, Danylchuk K, Zwarenstein M, Gray CM, Wyke S, Bunn C, Petrella RJ. Hockey Fans in Training (Hockey FIT) pilot study protocol: a gender-sensitized weight loss and healthy lifestyle program for overweight and obese male hockey fans. BMC Public Health. 2016 Oct 19;16(1):1096. doi: 10.1186/s12889-016-3730-5.
Results Reference
derived

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

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