Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial
27 september 2017 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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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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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Hockey FIT program
12-week active phase - exercise and healthy living program (1x/week; 90 minutes/session); 40-week maintenance phase (individualized approach)
|
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
Andra namn:
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Inget ingripande: Usual-care wait-list control
No active intervention (usual care)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Weight loss (absolute and percentage)
Tidsram: 12 weeks
|
Measured using digital weight scale
|
12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Weight loss (absolute and percentage)
Tidsram: 12 months (Hockey FIT group only)
|
Measured using digital weight scale
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12 months (Hockey FIT group only)
|
|
Average steps per day using pedometer
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured over a 7-day period using pedometers
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Total physical activity in MET-minutes/week using questionnaire
Tidsram: 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)
|
|
Time spent in sedentary activity using questionnaire
Tidsram: 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)
|
|
Eating habits: Fatty food score using questionnaire
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured by the modified Dietary Instrument for Nutrition Education
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12 weeks (& 12 months - Hockey FIT group only)
|
|
Eating habits: fruit and vegetable score using questionnaire
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured by the modified Dietary Instrument for Nutrition Education
|
12 weeks (& 12 months - Hockey FIT group only)
|
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Eating habits: sugary food score using questionnaire
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured by the modified Dietary Instrument for Nutrition Education
|
12 weeks (& 12 months - Hockey FIT group only)
|
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Eating habits: Starting the conversation summary score using questionnaire
Tidsram: 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
Tidsram: 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)
|
12 weeks (& 12 months - Hockey FIT group only)
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Resting systolic blood pressure
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using automated blood pressure monitor
|
12 weeks (& 12 months - Hockey FIT group only)
|
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Resting diastolic blood pressure
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using automated blood pressure monitor
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Waist circumference
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
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Measured using tape measure
|
12 weeks (& 12 months - Hockey FIT group only)
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Body mass index using height and weight measures
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
|
Height will be measured with a portable stadiometer; weight will be measured with a digital weight scale
|
12 weeks (& 12 months - Hockey FIT group only)
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Self-esteem summary score using questionnaire
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
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Summary score from Rosenberg Self Esteem Scale
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Positive affect score using questionnaire
Tidsram: 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
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
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Measured by the International Positive and Negative Affect Schedule Short Form
|
12 weeks (& 12 months - Hockey FIT group only)
|
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Health-related quality of life: Descriptive health state using questionnaire
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
|
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
Tidsram: 12 weeks (& 12 months - Hockey FIT group only)
|
EQ VAS measured by EQ-5D-3L
|
12 weeks (& 12 months - Hockey FIT group only)
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Samarbetspartners och utredare
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Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2015
Primärt slutförande (Faktisk)
1 augusti 2015
Avslutad studie (Faktisk)
1 juni 2016
Studieregistreringsdatum
Först inskickad
26 februari 2015
Först inskickad som uppfyllde QC-kriterierna
18 mars 2015
Första postat (Uppskatta)
24 mars 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 oktober 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 september 2017
Senast verifierad
1 september 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- pHFIT123
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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