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Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial

27. september 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 6K1
        • London Knights
      • Sarnia, Ontario, Canada, N7S 6K4
        • Sarnia Sting

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Hockey FIT program
12-week active phase - exercise and healthy living program (1x/week; 90 minutes/session); 40-week maintenance phase (individualized approach)
Adfærdsmæssigt: Hockey FIT Program
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 navne:
  • Hockey Fans in Training Program
  • Hockey Fans in Training
  • Hockey FIT
Ingen indgriben: Usual-care wait-list control
No active intervention (usual care)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight loss (absolute and percentage)
Tidsramme: 12 weeks
Measured using digital weight scale
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Western University, Canada

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2015

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

26. februar 2015

Først indsendt, der opfyldte QC-kriterier

18. marts 2015

Først opslået (Skøn)

24. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • pHFIT123

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Hockey FIT Program

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