Cancer PreventionNCT03059199
HAT TRICK: An Innovative Health Promotion Program for Men
A study testing Single-Arm Feasibility Study in people with Cancer Prevention, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this research is to implement and evaluate the feasibility of the HAT- TRICK Program, a gender- sensitive intervention program targeting physical activity, healthy eating and connectedness in men living in the Okanagan Region, BC. Read more about this study
- Who is it for?
- Ages 35 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Prevention
- What is being tested?
- Single-Arm Feasibility Study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2016to 22 Jun 2018
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men over the age of 35 years
- Residing in the Okanagan Region of British Columbia Canada
- Accumulate <150mins of moderate to vigorous physical activity a week
- Have a BMI >25kg/m2
- Pant size of >38"
Who cannot join
- No specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HAT TRICK: Examining the Feasibility of a Gender Sensitive Intervention Focused on Physical Activity, Healthy Eating and Connectedness in Male Hockey Fans
The purpose of this research is to implement and evaluate the feasibility of the HAT- TRICK Program, a gender- sensitive intervention program targeting physical activity, healthy eating and connectedness in men living in the Okanagan Region, BC.
Read the detailed description
Despite the benefits associated with lifestyle changes, men are less likely than women to engage in healthy lifestyle behaviours. Many men are reluctant and/or 'hard-to-reach', making it difficult to implement chronic illness prevention initiatives. Traditionally, a central challenge associated with engaging men in their health were perceptions that attention to one's health ran counter to masculine ideals of strength, self-reliance and independence. Thus, many men refrain from engaging in health promotion behaviors, such as PA and healthy eating. Research has highlighted the potential for professional sports teams/clubs to attract and engage men in healthy lifestyle behaviours. Such a strategy has been recognised as very powerful due to the traditional male environment within these clubs and the social-cultural connections the men often make with particular teams in terms of loyalty, identity and belonging. Thus, the purpose of this research is to develop and evaluate the feasibility of the HAT-TRICK Program, a gender-sensitive intervention program targeting PA, healthy eating and connectedness in men living in Kelowna, BC. This program will be delivered as a collaborative effort between the research team and the Kelowna Rockets, a major junior ice hockey team in Kelowna, BC. The Kelowna Rockets play in a centre with a capacity of over 6,000 and have one of the most loyal season ticket holders base in the Western Hockey League, with 4,500; the majority being men and between the ages of 40-70 years old. With assistance from the Rockets, participants (N=30) will be recruited via season ticket holders, at hockey games, though the Rockets webpage and local print and electronic media. Participants meeting all eligibility criteria will be invited to participate in the 12 week HAT-TRICK Program which will consist of a once a week, 90 minute combined physical activity (e.g., resistance training, "boot-camp" training, floor hockey, stair climbing) and health education session (e.g., goal setting, self-monitoring, barriers and benefits to PA, dealing with set-backs, healthy eating, alcohol consumption, etc.) to be held at the Kelowna Rockets game and training facility. Kelowna Rockets personnel (e.g., athletic therapist, nutritionist) and community experts (e.g., chef, fitness trainer) will be invited to lead some of the PA and nutrition sessions. Kelowna Rockets players will also visit the group during selected sessions to engage in the PA training with the men, further encouraging social support, connectedness and camaraderie. Primary (feasibility and acceptability) and secondary (PA, nutrition, quality of life, connectedness, anthropometrics) outcome measures will be evaluated using a mix-methods approach including; focus groups, self-reported questionnaires and objective physical activity and anthropometric methods. All measures will be collected at baseline, post-intervention (12 weeks) and at 9-month follow-up. Findings from the primary and secondary outcome measures will be used to refine the HAT-TRICK program in preparation for a full-scale evaluation (RCT). Innovative prevention and health promoting approaches are needed to better serve this 'hard to reach' population. This innovative program utilizes a gender sensitive approach to attract and engage men, providing them with a program that recognises their masculine values and interests. Furthermore, the collaborative (i.e., Kelowna Rockets) nature of this program is poised to reach a large proportion of men in the Okanagan by capitalizing on the social-cultural connections men often make with sports teams and using this as the lynchpin to engaging men in health behaviours.
- Conditions
- Cancer Prevention
- Being tested
- Single-Arm Feasibility Study
- Keywords
- Prospective/Retrospective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Arm Feasibility StudyBehavioural
Participants are provided with the HAT TRICK Playbook, a resource manual including weekly healthy eating and physical activity challenges and tracking logs. Each face-to-face session is facilitated by trained research staff, community partners, and health care professionals. Weekly sessions include information on physical activity, healthy eating, and behaviour change techniques (e.g., social support, goal setting, self-monitoring) and include an opportunity to be active/exercise.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Feasibility Study | Experimental | 12-week, 1x/week, 90-minute face-to-face sessions. Receives: Behavioral: Single-Arm Feasibility Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Feasibility
Program feasibility will be evaluated using mixed-methods to explore program delivery, recruitment, participant and facilitator satisfaction, challenges and issues faced during the program, and recommended changes to the program. Methods for collecting feasibility data will include: 1) program satisfaction/acceptability questionnaire for all participants; 2) semi-structured telephone interviews with a sub-sample of the HAT TRICK participant (telephone interviews provide rich qualitative data and are time \& resource efficient; 3) semi-structured interviews with guest presenters and club 'insiders'.
Measured: Post-Intervention (12-weeks)
Secondary outcomes (8)
Dietary Behaviour
Measured by the Dietary Instrument for Nutrition Education (DINE) questionnaire.
Measured: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Physical Activity Behaviour
Measured using the Actigraph GT3X+© accelerometer and Godin's Leisure Time Exercise Questionnaire (GLTEQ). The Actigraph GT3X+©, which is the 'gold standard' measure of physical activity in adults, will be worn by all participants during all waking hours over 7 consecutive days.
Measured: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Anthropometrics
Measures of height, weight, waist circumference, and blood pressure
Measured: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Health-Related Quality of Life
Health-related quality of life will be assessed using the validated SF-12V2 Health Survey.
Measured: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Social Connectedness
Measured using the Abbreviated Duke Social Support Scale.
Measured: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Alcohol Consumption
Measured using a 7-day alcohol recall.
Measured: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Sedentary Behaviour
Measured using the Marshall Sitting Questionnaire.
Measured: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Risk of Depression
Measured using the Male Depression Risk Scale.
Measured: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start20 Oct 2016
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer PreventionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Cristina Caperchione, University of British Columbia
- Investigators
- Cristina Caperchione, PhD, Principal investigator, UBCO Health and Exercise Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059199
- Sponsor's protocol ID
- H1600736
- Status last verified
- Oct 2018
- First submitted
- 18 Nov 2016
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only the principal investigators and UBC research team members will have access to the raw data. CO-I's external to UBC will not require access to raw participant data. Any data that are shared will be aggregate data and have all identifiers removed. All of these individuals have training in issues concerning privacy, confidentiality, and are aware of their responsibilities to maintain these.
Publications
Caperchione CM, Bottorff JL, Oliffe JL, Johnson ST, Hunt K, Sharp P, Fitzpatrick KM, Price R, Goldenberg SL. The HAT TRICK programme for improving physical activity, healthy eating and connectedness among overweight, inactive men: study protocol of a pragmatic feasibility trial. BMJ Open. 2017 Sep 6;7(9):e016940. doi: 10.1136/bmjopen-2017-016940.
PubMed 28882920Sharp P, Bottorff JL, Hunt K, Oliffe JL, Johnson ST, Dudley L, Caperchione CM. Men's Perspectives of a Gender-Sensitized Health Promotion Program Targeting Healthy Eating, Active Living, and Social Connectedness. Am J Mens Health. 2018 Nov;12(6):2157-2166. doi: 10.1177/1557988318799159. Epub 2018 Sep 20.
PubMed 30234419Sharp P, Bottorff JL, Oliffe JL, Hunt K, Caperchione CM. Process evaluation of HAT TRICK: feasibility, acceptability and opportunities for programme refinement. Health Educ Res. 2020 Dec 23;35(6):605-617. doi: 10.1093/her/cyaa029.
PubMed 33099636
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAT TRICK: Examining the Feasibility of a Gender Sensitive Intervention Focused on Physical Activity, Healthy Eating and Connectedness in Male Hockey Fans
- ClinicalTrials.gov ID
- NCT03059199
- Acronym / sponsor ID
- H1600736
- Conditions
- Cancer Prevention
- Keywords
- Prospective/Retrospective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to implement and evaluate the feasibility of the HAT- TRICK Program, a gender- sensitive intervention program targeting physical activity, healthy eating and connectedness in men living in the Okanagan Region, BC.
Detailed description
Despite the benefits associated with lifestyle changes, men are less likely than women to engage in healthy lifestyle behaviours. Many men are reluctant and/or 'hard-to-reach', making it difficult to implement chronic illness prevention initiatives. Traditionally, a central challenge associated with engaging men in their health were perceptions that attention to one's health ran counter to masculine ideals of strength, self-reliance and independence. Thus, many men refrain from engaging in health promotion behaviors, such as PA and healthy eating. Research has highlighted the potential for professional sports teams/clubs to attract and engage men in healthy lifestyle behaviours. Such a strategy has been recognised as very powerful due to the traditional male environment within these clubs and the social-cultural connections the men often make with particular teams in terms of loyalty, identity and belonging. Thus, the purpose of this research is to develop and evaluate the feasibility of the HAT-TRICK Program, a gender-sensitive intervention program targeting PA, healthy eating and connectedness in men living in Kelowna, BC. This program will be delivered as a collaborative effort between the research team and the Kelowna Rockets, a major junior ice hockey team in Kelowna, BC. The Kelowna Rockets play in a centre with a capacity of over 6,000 and have one of the most loyal season ticket holders base in the Western Hockey League, with 4,500; the majority being men and between the ages of 40-70 years old. With assistance from the Rockets, participants (N=30) will be recruited via season ticket holders, at hockey games, though the Rockets webpage and local print and electronic media. Participants meeting all eligibility criteria will be invited to participate in the 12 week HAT-TRICK Program which will consist of a once a week, 90 minute combined physical activity (e.g., resistance training, "boot-camp" training, floor hockey, stair climbing) and health education session (e.g., goal setting, self-monitoring, barriers and benefits to PA, dealing with set-backs, healthy eating, alcohol consumption, etc.) to be held at the Kelowna Rockets game and training facility. Kelowna Rockets personnel (e.g., athletic therapist, nutritionist) and community experts (e.g., chef, fitness trainer) will be invited to lead some of the PA and nutrition sessions. Kelowna Rockets players will also visit the group during selected sessions to engage in the PA training with the men, further encouraging social support, connectedness and camaraderie. Primary (feasibility and acceptability) and secondary (PA, nutrition, quality of life, connectedness, anthropometrics) outcome measures will be evaluated using a mix-methods approach including; focus groups, self-reported questionnaires and objective physical activity and anthropometric methods. All measures will be collected at baseline, post-intervention (12 weeks) and at 9-month follow-up. Findings from the primary and secondary outcome measures will be used to refine the HAT-TRICK program in preparation for a full-scale evaluation (RCT). Innovative prevention and health promoting approaches are needed to better serve this 'hard to reach' population. This innovative program utilizes a gender sensitive approach to attract and engage men, providing them with a program that recognises their masculine values and interests. Furthermore, the collaborative (i.e., Kelowna Rockets) nature of this program is poised to reach a large proportion of men in the Okanagan by capitalizing on the social-cultural connections men often make with sports teams and using this as the lynchpin to engaging men in health behaviours.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Feasibility Study | Experimental | Behavioral: Single-Arm Feasibility Study12-week, 1x/week, 90-minute face-to-face sessions. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men over the age of 35 years
- Residing in the Okanagan Region of British Columbia Canada
- Accumulate <150mins of moderate to vigorous physical activity a week
- Have a BMI >25kg/m2
- Pant size of >38"
Key exclusion criteria (1 listed)
- No specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Arm Feasibility StudyParticipants are provided with the HAT TRICK Playbook, a resource manual including weekly healthy eating and physical activity challenges and tracking logs. Each face-to-face session is facilitated by trained research staff, community partners, and health care professionals. Weekly sessions include information on physical activity, healthy eating, and behaviour change techniques (e.g., social support, goal setting, self-monitoring) and include an opportunity to be active/exercise. | Behavioural | Single-Arm Feasibility Study |
Primary outcome
Program Feasibility
Time frame: Post-Intervention (12-weeks)
Program feasibility will be evaluated using mixed-methods to explore program delivery, recruitment, participant and facilitator satisfaction, challenges and issues faced during the program, and recommended changes to the program. Methods for collecting feasibility data will include: 1) program satisfaction/acceptability questionnaire for all participants; 2) semi-structured telephone interviews with a sub-sample of the HAT TRICK participant (telephone interviews provide rich qualitative data and are time \& resource efficient; 3) semi-structured interviews with guest presenters and club 'insiders'.
8 secondary outcomes
Dietary Behaviour
Time frame: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Physical Activity Behaviour
Time frame: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Anthropometrics
Time frame: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Health-Related Quality of Life
Time frame: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Social Connectedness
Time frame: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Alcohol Consumption
Time frame: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Sedentary Behaviour
Time frame: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Risk of Depression
Time frame: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Background: PubMed 28882920Caperchione CM, Bottorff JL, Oliffe JL, Johnson ST, Hunt K, Sharp P, Fitzpatrick KM, Price R, Goldenberg SL. The HAT TRICK programme for improving physical activity, healthy eating and connectedness among overweight, inactive men: study protocol of a pragmatic feasibility trial. BMJ Open. 2017 Sep 6;7(9):e016940. doi: 10.1136/bmjopen-2017-016940.
- Results publication: PubMed 30234419Sharp P, Bottorff JL, Hunt K, Oliffe JL, Johnson ST, Dudley L, Caperchione CM. Men's Perspectives of a Gender-Sensitized Health Promotion Program Targeting Healthy Eating, Active Living, and Social Connectedness. Am J Mens Health. 2018 Nov;12(6):2157-2166. doi: 10.1177/1557988318799159. Epub 2018 Sep 20.
- Derived from this study: PubMed 33099636Sharp P, Bottorff JL, Oliffe JL, Hunt K, Caperchione CM. Process evaluation of HAT TRICK: feasibility, acceptability and opportunities for programme refinement. Health Educ Res. 2020 Dec 23;35(6):605-617. doi: 10.1093/her/cyaa029.
- HAT TRICK program information and participant recruitment webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only the principal investigators and UBC research team members will have access to the raw data. CO-I's external to UBC will not require access to raw participant data. Any data that are shared will be aggregate data and have all identifiers removed. All of these individuals have training in issues concerning privacy, confidentiality, and are aware of their responsibilities to maintain these.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Caperchione, PhD principal investigator
UBCO Health and Exercise Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Arm Feasibility Study in people with Cancer Prevention, run by University of British Columbia at 1 site 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 5 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 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Program Feasibility (time frame: Post-Intervention (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 NCT03059199, which also lists 3 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 1 Nov 2018.