Condition category
Cancer
Date applied
28/07/2016
Date assigned
29/07/2016
Last edited
03/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Despite the health benefits associated with leading a healthy lifestyle, such as increased physical activity and a healthy diet, men are less likely than women to engage in healthy lifestyle behaviours. Yet, more Canadian males are diagnosed with and die from cancer than Canadian women each year. Therefore a need exists for innovative strategies of encouraging healthy lifestyle changes that appeal to men. Previous research in the area of men’s health and physical activity suggests lifestyle programs must be tailored to reflect men’s values and interests in order to successfully engage them. Recent research has also shown that aligning with professional/elite sports teams and clubs and delivering information in sport settings is one effective way to attract and engage men in healthy lifestyle behaviours. The HAT-TRICK program is an innovative and male-friendly approach to increasing physical activity, improving diet, and enhancing social connectedness for men living in the Okanagan Region of British Columbia, Canada. This 12-week, face-to-face program will be delivered in connection with the Kelowna Rockets Hockey team, a major junior ice hockey team that play in the Western Hockey League. The aim of this study is to investigate the effectiveness of this program and to find out if it is acceptable to men taking part.

Who can participate?
Men over the age of 40 who are overweight and do up to 150 minutes of exercise a week

What does the study involve?
All participants take part in the HAT-TRICK program, which consists of 90 minute sessions once a week for 12 weeks. Each 90-minute weekly session is led by trained research personnel and community experts in the areas of physical activity, healthy eating, and behaviour change. These experts include local health professionals (e.g. nutritionist, fitness trainer), Kelowna Rockets staff and players, as well as other community personalities. At the start of the study and then after the 12 week program and 9 months later, participants are interviewed about their opinions of the program and complete a number of questionnaires to measure their exercise levels, diet, social connectedness and quality of life. Participants are also weighed and measured, as well as having their blood pressure taken at these times.

What are the possible benefits and risks of participating?
Although no benefits can be guaranteed, potential benefits that may include; improvements in overall physical and mental health as a result of increased physical activity levels, improved understanding about the benefits of physical activity and other healthy lifestyle behaviours (i.e. healthy eating, stress management), increased social interaction and support. The study involves no foreseeable risks or harm to participants. However, participants will be asked to work towards meeting the minimum recommended Canadian Physical Activity Guidelines (150 minutes of exercise per week in bouts of 10 minutes or more). Becoming physically active and progressively increasing physical activity may potentially include some risk of injury, such as muscle soreness or strains associated with being physically active. To limit any concerns regarding these minor injuries, information about reducing this risk of injury, such as education about stretching and starting off slowly and building up physical activity levels will be provided during the weekly sessions.

Where is the study run from?
1. University of British Columbia (Canada)
2. Prospera Place (Canada)

When is the study starting and how long is it expected to run for?
February 2016 to February 2018

Who is funding the study?
Canadian Cancer Society Research Institute (Canada)

Who is the main contact?
1. Mr Paul Sharp (public)
2. Dr Cristina Caperchione (scientific)

Trial website

Contact information

Type

Public

Primary contact

Mr Paul Sharp

ORCID ID

http://orcid.org/0000-0001-5616-3181

Contact details

University of British Columbia
3333 University Way
Kelowna
V1V 1V7
Canada

Type

Scientific

Additional contact

Dr Cristina Caperchione

ORCID ID

http://orcid.org/0000-0003-2290-5946

Contact details

University of British Columbia
3333 University Way
Kelowna
V1V 1V7
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HAT-TRICK

Study information

Scientific title

HAT-TRICK: Examining the feasibility of a gender-sensitive intervention focused on physical activity, healthy eating and connectedness in male hockey fans

Acronym

HAT-TRICK

Study hypothesis

The study’s aims are to:
1. Evaluate the feasibility and acceptability of the proposed intervention program
2. Provide an estimate of effectiveness in order to refine the program model in preparation for conducting a randomized control trial (RCT)

Ethics approval

University of British Columbia's Behavioural Research Ethics Board, 22/04/2016, ref: H16-00736

Study design

Non-randomised feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer prevention

Intervention

HAT-TRICK consists of 12 weekly, 90 minute sessions encompassing physical activity, healthy eating, and behaviour change techniques (e.g., social support, goal setting, self-monitoring). The program will be facilitated by research personnel trained in health promoting behaviours (i.e. physical activity and nutrition) and behaviour change techniques. In addition, community and club experts will lead some of the sessions (e.g. Athletic Therapist will lead a physical activity sessions and a local nutritionist will lead a nutrition session). Players of the hockey team will also visit the group during selected sessions to engage in the physical activity training with the men, further encouraging social support, connectedness and camaraderie. Including local experts and team ‘insiders’ will help to build a community-team partnership, which will be vital to future dissemination and sustainability. All components of the project have been designed with a gender-sensitive approach and all resources and materials will incorporate a masculine ‘look and feel’ and provide clear, positive, and direct messaging around physical activity and healthy eating.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Feasibility and acceptability of the program is measured at 12 weeks by:
1. Program satisfaction/acceptability questionnaire for all participants
2. Semi-structured telephone interviews with a sub-sample of the HAT-TRICK participant
3. Semi-structured interviews with guest presenters and club ‘insiders’

Secondary outcome measures

1. Physical activity will be measured by the Actigraph GT3X+© accelerometer, worn by all participants during all waking hours over 7 consecutive days, and the Godin’s Leisure Time Exercise Questionnaire (GLTEQ) at baseline, post-intervention (12 weeks) and at 9-months follow-up
2. Dietary behaviours will be assessed by the Dietary Instrument for Nutrition Education (DINE) questionnaire over 7 days of the study at baseline, post-intervention (12 weeks) and at 9-months follow-up
3. Social connectedness will be assessed using the validated Relatedness to Others in Physical Activity (ROPA) Scale at baseline, post-intervention (12 weeks) and at 9-months follow-up
4. Quality of life will be assessed using the validated SF-36 at baseline, post-intervention (12 weeks) and at 9-months follow-up
5. Anthropometric data (height, weight, waist circumference, and blood pressure) is collected at baseline, post-intervention (12 weeks) and at 9-months follow-up

Overall trial start date

01/02/2016

Overall trial end date

01/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men over the age of 40 years
2. Residing in the Okanagan Region of British Columbia Canada
3. Accumulate <150mins of moderate to vigorous physical activity a week
4. Have a BMI >28kg/m2
5. Pant size of >38”

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

45

Participant exclusion criteria

Not meeting inclusion criteria.

Recruitment start date

01/08/2016

Recruitment end date

01/02/2017

Locations

Countries of recruitment

Canada

Trial participating centre

University of British Columbia
3333 University Way
Kelowna
V1V 1V7
Canada

Trial participating centre

Prospera Place
1223 Water Street
Kelowna
V1Y 9V1
Canada

Sponsor information

Organisation

University of British Columbia

Sponsor details

3333 University Way
Kelowna
V1V 1V7
Canada

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Canadian Cancer Society Research Institute

Alternative name(s)

Société Canadienne du Cancer, CCSRI

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

Canada

Results and Publications

Publication and dissemination plan

Planned publications in a high-impact peer reviewed journal may include, but are not limited to, a protocol paper, feasibility paper, and/or outcomes paper. Dissemination will also occur via academic conferences and community-based presentations. Presentations and publications are planned for late 2017/early 2018.

Intention to publish date

31/01/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/08/2016: Verified study status with principal investigator.