Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial
2017年9月27日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
80
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Ontario
-
London、Ontario、カナダ、N6A 6K1
- London Knights
-
Sarnia、Ontario、カナダ、N7S 6K4
- Sarnia Sting
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
35年～65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
|
|
介入なし：Usual-care wait-list control
No active intervention (usual care)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weight loss (absolute and percentage)
時間枠：12 weeks
|
Measured using digital weight scale
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weight loss (absolute and percentage)
時間枠：12 months (Hockey FIT group only)
|
Measured using digital weight scale
|
12 months (Hockey FIT group only)
|
|
Average steps per day using pedometer
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：12 weeks (& 12 months - Hockey FIT group only)
|
Measured using automated blood pressure monitor
|
12 weeks (& 12 months - Hockey FIT group only)
|
|
Waist circumference
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：12 weeks (& 12 months - Hockey FIT group only)
|
EQ VAS measured by EQ-5D-3L
|
12 weeks (& 12 months - Hockey FIT group only)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年4月1日
一次修了 (実際)
2015年8月1日
研究の完了 (実際)
2016年6月1日
試験登録日
最初に提出
2015年2月26日
QC基準を満たした最初の提出物
2015年3月18日
最初の投稿 (見積もり)
2015年3月24日
学習記録の更新
投稿された最後の更新 (実際)
2017年10月2日
QC基準を満たした最後の更新が送信されました
2017年9月27日
最終確認日
2017年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。