O'Regan Andrew, Glynn Liam, Garcia Bengoechea Enrique, Casey Monica, Clifford Amanda, Donnelly Alan, Murphy Andrew W, Gallagher Stephen, Gillespie Paddy, Newell John, Harkin Mary, Macken Phelim, Sweeney John, Foley-Walsh Mo, Quinn Geraldine, Ng Kwok, O'Sullivan Nollaig, Balfry Gearoid, Woods Catherine
1Graduate Entry Medical School, University of Limerick, Limerick, Ireland.
2Department of Physical Education & Sport Sciences, University of Limerick, Limerick, Ireland.
Pilot Feasibility Stud. 2019 Jul 9;5:88. doi: 10.1186/s40814-019-0473-y. eCollection 2019.
There is overwhelming evidence to support the promotion of physical activity in adults in terms of benefits to well-being, physical and mental health. Physical activity guidelines suggest that adults should accumulate at least 150 min of moderate to vigorous physical activity per week. In Ireland, the majority of adults do not achieve these guidelines, with costs to health and economy. 'Move for Life' (MFL) employs behavioural change techniques delivered by an instructor and peer mentor, using a train-the-trainer (cascade) model. This study will conduct a feasibility cluster randomised controlled trial of the MFL intervention for modifying physical activity behaviours in inactive adults aged 45 years and older.
The trial is set in eight Local Sports Partnership (LSP) hubs that have structured physical activity programmes. The hubs are the units of randomisation (clusters), and individuals are the units of analysis (participants). Eligible participants will contact one of the hubs, with each hub running four physical activity programmes. Each programme requires between 12-15 inactive adults, resulting in 48-60 participants per hub. Allowing for 20% dropout rate, an additional 96 people will be recruited giving a maximum sample of 576. The hub will be randomised: true control, usual programme or MFL intervention. The true control group will be given information about physical activity but will not be included in a programme for the duration of the trial; the intervention will involve the instructor training one (or more) of the participants to be a peer mentor using an educational toolkit; and usual care groups will have physical activity classes delivered as normal. Baseline data will collect physical activity measures and follow-up measurements will be obtained at 3 and 6 months. All participants will be asked to wear a device for measuring activity on the thigh (activPAL) for 7 days before commencing the programme and at 3 and 6 months. The primary objective of the study is to investigate if it is feasible to deliver the intervention and collect data on moderate to vigorous physical activity (MVPA) on all participants, thereby providing valuable information to guide sample size calculation for a future, more definitive trial.
ISRCTN11235176.
有大量证据支持在成年人中推广体育活动对幸福感、身心健康有益。体育活动指南建议成年人每周应累计进行至少150分钟的中等至剧烈体育活动。在爱尔兰，大多数成年人未达到这些指南要求，这对健康和经济造成了损失。“为生活而动”（MFL）采用由教练和同伴导师提供的行为改变技巧，运用培训培训师（级联）模式。本研究将对MFL干预措施进行可行性整群随机对照试验，以改变45岁及以上不活跃成年人的体育活动行为。
该试验在八个设有结构化体育活动项目的地方体育合作伙伴（LSP）中心进行。中心是随机分组单位（整群），个体是分析单位（参与者）。符合条件的参与者将联系其中一个中心，每个中心开展四个体育活动项目。每个项目需要12 - 15名不活跃成年人，每个中心有48 - 60名参与者。考虑到20%的失访率，将额外招募96人，最大样本量为576人。中心将被随机分组：真正对照组、常规项目组或MFL干预组。真正对照组将获得有关体育活动的信息，但在试验期间不会被纳入项目；干预措施将包括教练使用教育工具包培训一名（或多名）参与者成为同伴导师；常规护理组将按正常情况开展体育活动课程。基线数据将收集体育活动测量指标，随访测量将在3个月和6个月时进行。所有参与者将被要求在开始项目前、3个月和6个月时佩戴一个用于测量大腿活动的设备（activPAL）7天。该研究的主要目的是调查实施干预措施并收集所有参与者的中等至剧烈体育活动（MVPA）数据是否可行，从而为未来更具确定性的试验提供有价值的信息以指导样本量计算。
ISRCTN11235176。
