- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03059199
HAT TRICK: An Innovative Health Promotion Program for Men
30. Oktober 2018 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
61
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
British Columbia
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Kelowna, British Columbia, Kanada
- Prospera Place
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
35 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Männlich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Program Feasibility
Zeitfenster: 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'.
|
Post-Intervention (12-weeks)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Dietary Behaviour
Zeitfenster: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
|
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
Zeitfenster: 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
|
Anthropometrics
Zeitfenster: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
|
Measures of height, weight, waist circumference, and blood pressure
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Baseline, Post-Intervention (12-weeks), and 9-month follow-up
|
Health-Related Quality of Life
Zeitfenster: Baseline, Post-Intervention (12-weeks), and 9-month follow-up
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Cristina Caperchione, PhD, UBCO Health and Exercise Sciences
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
20. Oktober 2016
Primärer Abschluss (Tatsächlich)
22. Juni 2018
Studienabschluss (Tatsächlich)
22. Juni 2018
Studienanmeldedaten
Zuerst eingereicht
18. November 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. Februar 2017
Zuerst gepostet (Tatsächlich)
23. Februar 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. November 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. Oktober 2018
Zuletzt verifiziert
1. Oktober 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- H1600736
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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