Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial
27 septembre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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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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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
35 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
|
Aucune intervention: Usual-care wait-list control
No active intervention (usual care)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Weight loss (absolute and percentage)
Délai: 12 weeks
|
Measured using digital weight scale
|
12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Weight loss (absolute and percentage)
Délai: 12 months (Hockey FIT group only)
|
Measured using digital weight scale
|
12 months (Hockey FIT group only)
|
|
Average steps per day using pedometer
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 12 weeks (& 12 months - Hockey FIT group only)
|
Measured using automated blood pressure monitor
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Waist circumference
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 12 weeks (& 12 months - Hockey FIT group only)
|
EQ VAS measured by EQ-5D-3L
|
12 weeks (& 12 months - Hockey FIT group only)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2015
Achèvement primaire (Réel)
1 août 2015
Achèvement de l'étude (Réel)
1 juin 2016
Dates d'inscription aux études
Première soumission
26 février 2015
Première soumission répondant aux critères de contrôle qualité
18 mars 2015
Première publication (Estimation)
24 mars 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 octobre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 septembre 2017
Dernière vérification
1 septembre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- pHFIT123
Plan pour les données individuelles des participants (IPD)
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NON
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