Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial
27. september 2017 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
London, Ontario, Canada, N6A 6K1
- London Knights
-
Sarnia, Ontario, Canada, N7S 6K4
- Sarnia Sting
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
35 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
Andre navn:
|
|
Ingen inngripen: Usual-care wait-list control
No active intervention (usual care)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight loss (absolute and percentage)
Tidsramme: 12 weeks
|
Measured using digital weight scale
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight loss (absolute and percentage)
Tidsramme: 12 months (Hockey FIT group only)
|
Measured using digital weight scale
|
12 months (Hockey FIT group only)
|
|
Average steps per day using pedometer
Tidsramme: 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
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
International Physical Activity Questionnaire - Short Version
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Time spent in sedentary activity using questionnaire
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured by the International Physical Activity Questionnaire - Short Version
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Eating habits: Fatty food score using questionnaire
Tidsramme: 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)
|
|
Eating habits: fruit and vegetable score using questionnaire
Tidsramme: 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)
|
|
Eating habits: sugary food score using questionnaire
Tidsramme: 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)
|
|
Eating habits: Starting the conversation summary score using questionnaire
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured by Starting the Conversation Dietary Assessment Tool
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Alcohol consumption using recall questionnaire
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured by a 7-day alcohol recall (number of drinks in last 7 days)
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Resting systolic blood pressure
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured using automated blood pressure monitor
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Resting diastolic blood pressure
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured using automated blood pressure monitor
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Waist circumference
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured using tape measure
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Body mass index using height and weight measures
Tidsramme: 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)
|
|
Self-esteem summary score using questionnaire
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
Summary score from Rosenberg Self Esteem Scale
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Positive affect score using questionnaire
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured by the International Positive and Negative Affect Schedule Short Form
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Negative affect score using questionnaire
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured by the International Positive and Negative Affect Schedule Short Form
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Health-related quality of life: Descriptive health state using questionnaire
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
EQ-5D index measured by EQ-5D-3L
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Health-related quality of life: VAS using questionnaire
Tidsramme: 12 weeks (& 12 months - Hockey FIT group only)
|
EQ VAS measured by EQ-5D-3L
|
12 weeks (& 12 months - Hockey FIT group only)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2015
Primær fullføring (Faktiske)
1. august 2015
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
26. februar 2015
Først innsendt som oppfylte QC-kriteriene
18. mars 2015
Først lagt ut (Anslag)
24. mars 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. september 2017
Sist bekreftet
1. september 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- pHFIT123
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .