Clinical trial NCT02396524: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Chronic Disease
Lifestyle Intervention
Health Promotion
Sport Mentorship
Men
Health Technology
Prevention
Exercise
Diet
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 80
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weight loss (absolute and percentage)
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight loss (absolute and percentage)
timeFrame: 12 months (Hockey FIT group only)
measure: Average steps per day using pedometer
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Total physical activity in MET-minutes/week using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Time spent in sedentary activity using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Eating habits: Fatty food score using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Eating habits: fruit and vegetable score using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Eating habits: sugary food score using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Eating habits: Starting the conversation summary score using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Alcohol consumption using recall questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Resting systolic blood pressure
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Resting diastolic blood pressure
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Waist circumference
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Body mass index using height and weight measures
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Self-esteem summary score using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Positive affect score using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Negative affect score using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Health-related quality of life: Descriptive health state using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
measure: Health-related quality of life: VAS using questionnaire
timeFrame: 12 weeks (& 12 months - Hockey FIT group only)
Other outcomes:
Locations:
city: London
country: Canada
facility: London Knights
state: Ontario
city: Sarnia
country: Canada
facility: Sarnia Sting
state: Ontario
Study officials:
affiliation: University of Western Ontario, Lawson Health Research Institute
name: Robert J Petrella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.