- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02396524
Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial
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
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ontario
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London, Ontario, Kanada, N6A 6K1
- London Knights
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Sarnia, Ontario, Kanada, N7S 6K4
- Sarnia Sting
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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
Ostatní jména:
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Žádný zásah: Usual-care wait-list control
No active intervention (usual care)
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Weight loss (absolute and percentage)
Časové okno: 12 weeks
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Measured using digital weight scale
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12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Weight loss (absolute and percentage)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- pHFIT123
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