National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.
Institute for Physical Activity and Nutrition, Deakin University, Melbourne, VIC, Australia.
Trials. 2020 Feb 4;21(1):139. doi: 10.1186/s13063-019-4038-4.
A healthy lifestyle program that appeals to, and supports, obese New Zealand (NZ) European, Māori (indigenous) and Pasifika men to achieve weight loss is urgently needed. In Scotland, Football Fans in Training (FFIT), a weight management and healthy lifestyle program for overweight and obese men aged 35-65 years , delivered by community coaching staff at professional football clubs, has been shown to be beneficial and cost-effective. A pilot program inspired by FFIT but delivered by professional rugby clubs in NZ (n = 96) was shown to be effective in weight loss, improved physiological outcomes, and adherence to healthy lifestyle behaviors in overweight and obese men. The objective of this trial is to determine the effectiveness and cost-effectiveness of the Rugby Fans in Training New Zealand (RUFIT-NZ) program.
A pragmatic, two-arm, multi-center, randomized controlled trial involving 308 overweight and obese men aged 30-65 years, randomized to either an intervention group (n = 154) or a wait-list control group (n = 154). The intervention-group participated in the 12-week RUFIT-NZ program, a gender-sensitized, healthy lifestyle intervention adapted to the environment and cultural diversity of NZ and delivered through professional rugby clubs. Participants in the intervention group undergo physical training sessions, in addition to workshop-based sessions to learn about nutrition, physical activity, sleep, sedentary behavior, and a range of behavior-change strategies for sustaining a healthier lifestyle. The control group receives the program after 52 weeks. The primary outcome is change in body weight from baseline to 52 weeks. Secondary outcomes include change in body weight at 12 weeks; waist circumference, blood pressure, fitness, and lifestyle behaviors at 12 and 52 weeks; and cost-effectiveness. A process evaluation informed by the RE-AIM framework will evaluate potential implementation of RUFIT-NZ as an ongoing program in NZ after the trial.
This trial will investigate the effectiveness and cost-effectiveness of the RUFIT-NZ program in overweight and obese NZ men.
Australia New Zealand Clinical Trials Registry, ACTRN12619000069156. Registered on 18 January 2019, according to the World Health Organization Trial Registration Data Set. Universal Trial Number, U1111-1245-0645.
目前急需一种能够吸引并支持肥胖的新西兰（NZ）欧洲人、毛利人（土著）和太平洋岛民男性的健康生活方式计划，帮助他们减轻体重。在苏格兰，一项针对 35-65 岁超重和肥胖男性的名为“足球迷训练计划”（FFIT）的体重管理和健康生活方式计划，由职业足球俱乐部的社区教练提供，已被证明是有益且具有成本效益的。受 FFIT 启发并由 NZ 的职业橄榄球队提供的试点计划（n=96）在超重和肥胖男性中显示出了在减轻体重、改善生理结果和坚持健康生活方式行为方面的有效性。本试验的目的是确定“新西兰橄榄球迷训练计划”（RUFIT-NZ）的有效性和成本效益。
一项实用的、双臂的、多中心、随机对照试验，涉及 308 名年龄在 30-65 岁的超重和肥胖男性，随机分为干预组（n=154）或等待名单对照组（n=154）。干预组参加了为期 12 周的 RUFIT-NZ 计划，这是一个对性别敏感的健康生活方式干预计划，根据 NZ 的环境和文化多样性进行了调整，并通过职业橄榄球队提供。干预组的参与者参加体能训练课程，此外还参加基于工作坊的课程，学习营养、身体活动、睡眠、久坐行为以及一系列用于维持更健康生活方式的行为改变策略。对照组在 52 周后接受该计划。主要结局是从基线到 52 周时体重的变化。次要结局包括 12 周时的体重变化；12 周和 52 周时的腰围、血压、健康和生活方式行为；以及成本效益。基于 RE-AIM 框架的过程评估将评估 RUFIT-NZ 作为 NZ 后续计划的实施潜力。
本试验将研究 RUFIT-NZ 计划对 NZ 超重和肥胖男性的有效性和成本效益。
澳大利亚新西兰临床试验注册中心，ACTRN12619000069156。根据世界卫生组织试验登记数据集，于 2019 年 1 月 18 日注册。通用试验编号，U1111-1245-0645。
