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

• ClinicalTrials.gov Identifier: NCT02396524
• Recruitment Status: Completed
• First Posted: March 24, 2015
• Last Update Posted: October 2, 2017
• Sponsor: Western University, Canada
• Information provided by (Responsible Party): Robert Petrella, Western University, Canada

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.

Condition or disease	Intervention/treatment	Phase
Overweight; Obesity	Behavioral: Hockey FIT Program	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• 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 Start Date: April 2015
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hockey FIT program; 12-week active phase - exercise and healthy living program (1x/week; 90 minutes/session); 40-week maintenance phase (individualized approach)	Behavioral: Hockey FIT Program; 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; Other Names: Hockey Fans in Training Program; Hockey Fans in Training; Hockey FIT
No Intervention: Usual-care wait-list control; No active intervention (usual care)

Outcome Measures

Primary Outcome Measures :

1. Weight loss (absolute and percentage) [ Time Frame: 12 weeks ]
   Measured using digital weight scale

Secondary Outcome Measures :

1. Weight loss (absolute and percentage) [ Time Frame: 12 months (Hockey FIT group only) ]
   Measured using digital weight scale
2. Average steps per day using pedometer [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
   Measured over a 7-day period using pedometers
3. Total physical activity in MET-minutes/week using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
   International Physical Activity Questionnaire - Short Version
4. Time spent in sedentary activity using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
   Measured by the International Physical Activity Questionnaire - Short Version
5. Eating habits: Fatty food score using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
   Measured by the modified Dietary Instrument for Nutrition Education
6. Eating habits: fruit and vegetable score using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
   Measured by the modified Dietary Instrument for Nutrition Education
7. Eating habits: sugary food score using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
   Measured by the modified Dietary Instrument for Nutrition Education
8. Eating habits: Starting the conversation summary score using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
   Measured by Starting the Conversation Dietary Assessment Tool
9. Alcohol consumption using recall questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
   Measured by a 7-day alcohol recall (number of drinks in last 7 days)
10. Resting systolic blood pressure [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
    Measured using automated blood pressure monitor
11. Resting diastolic blood pressure [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
    Measured using automated blood pressure monitor
12. Waist circumference [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
    Measured using tape measure
13. Body mass index using height and weight measures [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
    Height will be measured with a portable stadiometer; weight will be measured with a digital weight scale
14. Self-esteem summary score using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
    Summary score from Rosenberg Self Esteem Scale
15. Positive affect score using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
    Measured by the International Positive and Negative Affect Schedule Short Form
16. Negative affect score using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
    Measured by the International Positive and Negative Affect Schedule Short Form
17. Health-related quality of life: Descriptive health state using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
    EQ-5D index measured by EQ-5D-3L
18. Health-related quality of life: VAS using questionnaire [ Time Frame: 12 weeks (& 12 months - Hockey FIT group only) ]
    EQ VAS measured by EQ-5D-3L

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Canada, Ontario

London Knights

London, Ontario, Canada, N6A 6K1

Sarnia Sting

Sarnia, Ontario, Canada, N7S 6K4

Sponsors and Collaborators

Western University, Canada

Investigators

• Principal Investigator: Robert J Petrella, MD, PhD; University of Western Ontario, Lawson Health Research Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Robert Petrella, Dr. Robert J. Petrella, Western University, Canada
• ClinicalTrials.gov Identifier: NCT02396524
• Other Study ID Numbers: pHFIT123
• First Posted: March 24, 2015
• Last Update Posted: October 2, 2017
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Robert Petrella, Western University, Canada:

Chronic Disease; Lifestyle Intervention; Health Promotion; Sport Mentorship; Men; Health Technology; Prevention; Exercise; Diet

Additional relevant MeSH terms:

Overweight; Overnutrition; Nutrition Disorders; Body Weight