NCT03059199

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

November 18, 2016

Last Update Submit

October 30, 2018

Conditions

Cancer Prevention

Keywords

Prospective/Retrospective

Outcome Measures

Primary Outcomes (1)

  • 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'.

    Post-Intervention (12-weeks)

Secondary Outcomes (8)

  • Dietary Behaviour

    Baseline, Post-Intervention (12-weeks), and 9-month follow-up

  • Physical Activity Behaviour

    Baseline, Post-Intervention (12-weeks), and 9-month follow-up

  • Anthropometrics

    Baseline, Post-Intervention (12-weeks), and 9-month follow-up

  • Health-Related Quality of Life

    Baseline, Post-Intervention (12-weeks), and 9-month follow-up

  • Social Connectedness

    Baseline, Post-Intervention (12-weeks), and 9-month follow-up

  • +3 more secondary outcomes

Study Arms (1)

Single-Arm Feasibility Study

EXPERIMENTAL

12-week, 1x/week, 90-minute face-to-face sessions.

Behavioral: Single-Arm Feasibility Study

Interventions

Single-Arm Feasibility StudyBEHAVIORAL

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.

Single-Arm Feasibility Study

Eligibility Criteria

Age35 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prospera Place

Kelowna, British Columbia, Canada

Location

Related Publications (3)

  • 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.

    PMID: 28882920BACKGROUND

  • Sharp 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.

    PMID: 30234419RESULT

  • Sharp 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.

    PMID: 33099636DERIVED

Related Links

Study Officials

  • Cristina Caperchione, PhD

    UBCO Health and Exercise Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2016

First Posted

February 23, 2017

Study Start

October 20, 2016

Primary Completion

June 22, 2018

Study Completion

June 22, 2018

Last Updated

November 1, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

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.

Locations

CA(1)