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OverweightNCT02396524

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

A study testing Hockey FIT Program in people with Overweight and Obesity, run by Western University, Canada at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Overweight, Obesity
What is being tested?
Hockey FIT Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesCanada
Study dates
Apr 2015to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Unable to comprehend letter of information and consent documentation

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • London Knights

    London, Ontario, N6A 6K1

  • Sarnia Sting

    Sarnia, Ontario, N7S 6K4

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Overweight, Obesity
Being tested
Hockey FIT Program
Keywords
Chronic Disease, Lifestyle Intervention, Health Promotion, Sport Mentorship, Men, Health Technology, Prevention, Exercise, Diet
Medical subject headings
Overweight, Obesity, Chronic Disease, Multiple Endocrine Neoplasia Type 1, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hockey FIT ProgramBehavioural

    Also called Hockey Fans in Training Program, Hockey Fans in Training, Hockey FIT

    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

Study groups in NCT02396524
Study groupRoleWhat they receive
Hockey FIT programExperimental12-week active phase - exercise and healthy living program (1x/week; 90 minutes/session); 40-week maintenance phase (individualized approach)
Receives: Behavioral: Hockey FIT Program
Usual-care wait-list controlNo interventionNo active intervention (usual care)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss (absolute and percentage)

    Measured using digital weight scale

    Measured: 12 weeks

Secondary outcomes (18)

  1. Weight loss (absolute and percentage)

    Measured using digital weight scale

    Measured: 12 months (Hockey FIT group only)

  2. Average steps per day using pedometer

    Measured over a 7-day period using pedometers

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  3. Total physical activity in MET-minutes/week using questionnaire

    International Physical Activity Questionnaire - Short Version

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  4. Time spent in sedentary activity using questionnaire

    Measured by the International Physical Activity Questionnaire - Short Version

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  5. Eating habits: Fatty food score using questionnaire

    Measured by the modified Dietary Instrument for Nutrition Education

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  6. Eating habits: fruit and vegetable score using questionnaire

    Measured by the modified Dietary Instrument for Nutrition Education

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  7. Eating habits: sugary food score using questionnaire

    Measured by the modified Dietary Instrument for Nutrition Education

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  8. Eating habits: Starting the conversation summary score using questionnaire

    Measured by Starting the Conversation Dietary Assessment Tool

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  9. Alcohol consumption using recall questionnaire

    Measured by a 7-day alcohol recall (number of drinks in last 7 days)

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  10. Resting systolic blood pressure

    Measured using automated blood pressure monitor

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  11. Resting diastolic blood pressure

    Measured using automated blood pressure monitor

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  12. Waist circumference

    Measured using tape measure

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  13. 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

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  14. Self-esteem summary score using questionnaire

    Summary score from Rosenberg Self Esteem Scale

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  15. Positive affect score using questionnaire

    Measured by the International Positive and Negative Affect Schedule Short Form

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  16. Negative affect score using questionnaire

    Measured by the International Positive and Negative Affect Schedule Short Form

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  17. Health-related quality of life: Descriptive health state using questionnaire

    EQ-5D index measured by EQ-5D-3L

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

  18. Health-related quality of life: VAS using questionnaire

    EQ VAS measured by EQ-5D-3L

    Measured: 12 weeks (& 12 months - Hockey FIT group only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionAug 2015
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02396524
Sponsor's protocol ID
pHFIT123
Status last verified
Sep 2017
First submitted
26 Feb 2015
Last updated
2 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 29183291

  • 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.

    PubMed 27756351

Questions about this trial

What is this clinical trial studying?

A study testing Hockey FIT Program in people with Overweight and Obesity, run by Western University, Canada at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss (absolute and percentage) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02396524, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.

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