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

Obesity Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396524
• Other study ID #: pHFIT123
• Status: Completed
• Phase: N/A
• First received: February 26, 2015
• Last updated: September 27, 2017
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2017
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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

Locations

Country	Name	City	State
Canada	London Knights	London	Ontario
Canada	Sarnia Sting	Sarnia	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss (absolute and percentage)	Measured using digital weight scale	12 weeks
Secondary	Weight loss (absolute and percentage)	Measured using digital weight scale	12 months (Hockey FIT group only)
Secondary	Average steps per day using pedometer	Measured over a 7-day period using pedometers	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Total physical activity in MET-minutes/week using questionnaire	International Physical Activity Questionnaire - Short Version	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Time spent in sedentary activity using questionnaire	Measured by the International Physical Activity Questionnaire - Short Version	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Eating habits: Fatty food score using questionnaire	Measured by the modified Dietary Instrument for Nutrition Education	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Eating habits: fruit and vegetable score using questionnaire	Measured by the modified Dietary Instrument for Nutrition Education	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Eating habits: sugary food score using questionnaire	Measured by the modified Dietary Instrument for Nutrition Education	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Eating habits: Starting the conversation summary score using questionnaire	Measured by Starting the Conversation Dietary Assessment Tool	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Alcohol consumption using recall questionnaire	Measured by a 7-day alcohol recall (number of drinks in last 7 days)	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Resting systolic blood pressure	Measured using automated blood pressure monitor	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Resting diastolic blood pressure	Measured using automated blood pressure monitor	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Waist circumference	Measured using tape measure	12 weeks (& 12 months - Hockey FIT group only)
Secondary	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	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Self-esteem summary score using questionnaire	Summary score from Rosenberg Self Esteem Scale	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Positive affect score using questionnaire	Measured by the International Positive and Negative Affect Schedule Short Form	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Negative affect score using questionnaire	Measured by the International Positive and Negative Affect Schedule Short Form	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Health-related quality of life: Descriptive health state using questionnaire	EQ-5D index measured by EQ-5D-3L	12 weeks (& 12 months - Hockey FIT group only)
Secondary	Health-related quality of life: VAS using questionnaire	EQ VAS measured by EQ-5D-3L	12 weeks (& 12 months - Hockey FIT group only)