- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03059199
HAT TRICK: An Innovative Health Promotion Program for Men
2018년 10월 30일 업데이트: Cristina Caperchione, University of British Columbia
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
61
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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British Columbia
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Kelowna, British Columbia, 캐나다
- Prospera Place
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
35년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
Inclusion Criteria:
- 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"
Exclusion Criteria:
- No specific exclusion criteria
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Single-Arm Feasibility Study
12-week, 1x/week, 90-minute face-to-face sessions.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Program Feasibility
기간: Post-Intervention (12-weeks)
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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'.
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Post-Intervention (12-weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dietary Behaviour
기간: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Measured by the Dietary Instrument for Nutrition Education (DINE) questionnaire.
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Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Physical Activity Behaviour
기간: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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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.
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Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Anthropometrics
기간: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Measures of height, weight, waist circumference, and blood pressure
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Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Health-Related Quality of Life
기간: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Health-related quality of life will be assessed using the validated SF-12V2 Health Survey.
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Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Social Connectedness
기간: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Measured using the Abbreviated Duke Social Support Scale.
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Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Alcohol Consumption
기간: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Measured using a 7-day alcohol recall.
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Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Sedentary Behaviour
기간: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Measured using the Marshall Sitting Questionnaire.
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Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Risk of Depression
기간: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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Measured using the Male Depression Risk Scale.
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Baseline, Post-Intervention (12-weeks), and 9-month follow-up
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Cristina Caperchione, PhD, UBCO Health and Exercise Sciences
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 10월 20일
기본 완료 (실제)
2018년 6월 22일
연구 완료 (실제)
2018년 6월 22일
연구 등록 날짜
최초 제출
2016년 11월 18일
QC 기준을 충족하는 최초 제출
2017년 2월 16일
처음 게시됨 (실제)
2017년 2월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 11월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 10월 30일
마지막으로 확인됨
2018년 10월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- H1600736
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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