- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02396524
Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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London, Ontario, Canada, N6A 6K1
- London Knights
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Sarnia, Ontario, Canada, N7S 6K4
- Sarnia Sting
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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)
|
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:
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No Intervention: Usual-care wait-list control
No active intervention (usual care)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss (absolute and percentage)
Time Frame: 12 weeks
|
Measured using digital weight scale
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss (absolute and percentage)
Time Frame: 12 months (Hockey FIT group only)
|
Measured using digital weight scale
|
12 months (Hockey FIT group only)
|
|
Average steps per day using pedometer
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured over a 7-day period using pedometers
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
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
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
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
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
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
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
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
|
12 weeks (& 12 months - Hockey FIT group only)
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Eating habits: sugary food score using questionnaire
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the modified Dietary Instrument for Nutrition Education
|
12 weeks (& 12 months - Hockey FIT group only)
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Eating habits: Starting the conversation summary score using questionnaire
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by Starting the Conversation Dietary Assessment Tool
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12 weeks (& 12 months - Hockey FIT group only)
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Alcohol consumption using recall questionnaire
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by a 7-day alcohol recall (number of drinks in last 7 days)
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Resting systolic blood pressure
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using automated blood pressure monitor
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Resting diastolic blood pressure
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using automated blood pressure monitor
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Waist circumference
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using tape measure
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12 weeks (& 12 months - Hockey FIT group only)
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Body mass index using height and weight measures
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
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Height will be measured with a portable stadiometer; weight will be measured with a digital weight scale
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12 weeks (& 12 months - Hockey FIT group only)
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Self-esteem summary score using questionnaire
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
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Summary score from Rosenberg Self Esteem Scale
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12 weeks (& 12 months - Hockey FIT group only)
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Positive affect score using questionnaire
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the International Positive and Negative Affect Schedule Short Form
|
12 weeks (& 12 months - Hockey FIT group only)
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Negative affect score using questionnaire
Time Frame: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the International Positive and Negative Affect Schedule Short Form
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
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
|
12 weeks (& 12 months - Hockey FIT group only)
|
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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
|
12 weeks (& 12 months - Hockey FIT group only)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- pHFIT123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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