Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial
27 september 2017 bijgewerkt door: Robert Petrella, Western University, Canada
Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial of an Exercise and Healthy Living Program for Middle-aged, Overweight and Obese Men
The Hockey Fans in Training (Hockey FIT) program aims to improve overweight men's physical fitness, eating habits and health-related lifestyle choices through a lifestyle modification program in collaboration with two Ontario Hockey League teams.
In this pilot pragmatic randomized controlled trial, the investigators plan to explore the potential for Hockey FIT to reduce a clinically important amount of weight, increase physical activity levels, and lead to improvements in other health-related outcomes.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
In the United Kingdom, the Football Fans in Training (FFIT) program was developed to encourage men to lead a healthier lifestyle through a sport-related medium. FFIT is a gender-sensitized, weight loss and healthy living program developed for delivery to overweight and obese men through professional football clubs. Published results from FFIT show that the program was able to actively recruit and engage men and for the men who participated, sustained weight loss and positive lifestyle change was observed (Hunt et al., 2014).
This study will use a two-arm, pilot pragmatic randomized controlled trial (RCT) design. The investigators will conduct the study in conjunction with two Ontario Junior A Hockey Clubs. Following assessment of eligibility and baseline measurements, men will be individually randomized (1:1; stratified by club) to either the intervention group (receiving the Hockey FIT program) or to the comparison group (usual care wait-list control). The comparison group will be offered to start the Hockey FIT program after a 12-week delay. All men (both intervention and comparison groups) will receive publicly available healthy eating and physical activity materials at baseline. Measurements will be taken at baseline and 12 weeks (both groups) and again at 12 months (intervention group only).
The results of this study will be used to inform a fully-powered RCT where the primary objective will be to determine whether, compared to the usual care wait-list control group, the Hockey FIT group will lose weight (at least 5% weight loss from baseline) at 12 months.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ontario
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London, Ontario, Canada, N6A 6K1
- London Knights
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Sarnia, Ontario, Canada, N7S 6K4
- Sarnia Sting
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
35 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
Inclusion Criteria:
- Objectively-measured body-mass index of at least 28 kg/m2
- Clear Physical Activity Readiness Questionnaire (PAR-Q) (i.e., either by answering "No" to all questions or receiving clearance from a health care provider)
Exclusion Criteria:
- Unable to comprehend letter of information and consent documentation
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Hockey FIT program
12-week active phase - exercise and healthy living program (1x/week; 90 minutes/session); 40-week maintenance phase (individualized approach)
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Active phase: a) Classroom-based education on successful weight management strategies and instruction on behaviour change techniques/dietary interventions; promote peer and other forms of social support; and b) Physical activity sessions in aerobic/strength/flexibility exercises.
Maintenance phase: Participants independently set new lifestyle prescriptions and goals and track their exercise, physical activity, and healthy eating with the support of a suite of free-of-charge health technology support tools
Andere namen:
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Geen tussenkomst: Usual-care wait-list control
No active intervention (usual care)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Weight loss (absolute and percentage)
Tijdsspanne: 12 weeks
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Measured using digital weight scale
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12 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Weight loss (absolute and percentage)
Tijdsspanne: 12 months (Hockey FIT group only)
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Measured using digital weight scale
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12 months (Hockey FIT group only)
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Average steps per day using pedometer
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured over a 7-day period using pedometers
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12 weeks (& 12 months - Hockey FIT group only)
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Total physical activity in MET-minutes/week using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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International Physical Activity Questionnaire - Short Version
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12 weeks (& 12 months - Hockey FIT group only)
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Time spent in sedentary activity using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the International Physical Activity Questionnaire - Short Version
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12 weeks (& 12 months - Hockey FIT group only)
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Eating habits: Fatty food score using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the modified Dietary Instrument for Nutrition Education
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12 weeks (& 12 months - Hockey FIT group only)
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Eating habits: fruit and vegetable score using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the modified Dietary Instrument for Nutrition Education
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12 weeks (& 12 months - Hockey FIT group only)
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Eating habits: sugary food score using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the modified Dietary Instrument for Nutrition Education
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12 weeks (& 12 months - Hockey FIT group only)
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Eating habits: Starting the conversation summary score using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by Starting the Conversation Dietary Assessment Tool
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12 weeks (& 12 months - Hockey FIT group only)
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Alcohol consumption using recall questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by a 7-day alcohol recall (number of drinks in last 7 days)
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12 weeks (& 12 months - Hockey FIT group only)
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Resting systolic blood pressure
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using automated blood pressure monitor
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12 weeks (& 12 months - Hockey FIT group only)
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Resting diastolic blood pressure
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using automated blood pressure monitor
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12 weeks (& 12 months - Hockey FIT group only)
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Waist circumference
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using tape measure
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12 weeks (& 12 months - Hockey FIT group only)
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Body mass index using height and weight measures
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Height will be measured with a portable stadiometer; weight will be measured with a digital weight scale
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12 weeks (& 12 months - Hockey FIT group only)
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Self-esteem summary score using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Summary score from Rosenberg Self Esteem Scale
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12 weeks (& 12 months - Hockey FIT group only)
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Positive affect score using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the International Positive and Negative Affect Schedule Short Form
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12 weeks (& 12 months - Hockey FIT group only)
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Negative affect score using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the International Positive and Negative Affect Schedule Short Form
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12 weeks (& 12 months - Hockey FIT group only)
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Health-related quality of life: Descriptive health state using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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EQ-5D index measured by EQ-5D-3L
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12 weeks (& 12 months - Hockey FIT group only)
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Health-related quality of life: VAS using questionnaire
Tijdsspanne: 12 weeks (& 12 months - Hockey FIT group only)
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EQ VAS measured by EQ-5D-3L
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12 weeks (& 12 months - Hockey FIT group only)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Blunt W, Gill DP, Sibbald SL, Riggin B, Pulford RW, Scott R, Danylchuk K, Gray CM, Wyke S, Bunn C, Petrella RJ. Optimization of the Hockey Fans in Training (Hockey FIT) weight loss and healthy lifestyle program for male hockey fans. BMC Public Health. 2017 Nov 28;17(1):916. doi: 10.1186/s12889-017-4926-z.
- Gill DP, Blunt W, De Cruz A, Riggin B, Hunt K, Zou G, Sibbald S, Danylchuk K, Zwarenstein M, Gray CM, Wyke S, Bunn C, Petrella RJ. Hockey Fans in Training (Hockey FIT) pilot study protocol: a gender-sensitized weight loss and healthy lifestyle program for overweight and obese male hockey fans. BMC Public Health. 2016 Oct 19;16(1):1096. doi: 10.1186/s12889-016-3730-5.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2015
Primaire voltooiing (Werkelijk)
1 augustus 2015
Studie voltooiing (Werkelijk)
1 juni 2016
Studieregistratiedata
Eerst ingediend
26 februari 2015
Eerst ingediend dat voldeed aan de QC-criteria
18 maart 2015
Eerst geplaatst (Schatting)
24 maart 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 oktober 2017
Laatste update ingediend die voldeed aan QC-criteria
27 september 2017
Laatst geverifieerd
1 september 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- pHFIT123
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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