UNASSIGNED: 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.
UNASSIGNED: ISRCTN11235176.
■该试验是在八个具有结构化体育活动计划的本地体育合作伙伴关系(LSP)中心进行的。中心是随机化的单位(集群),个人是分析的单位(参与者)。符合条件的参与者将联系其中一个中心,每个中心都有四个体育活动计划。每个项目需要12-15名不活跃的成年人,每个中心有48-60名参与者。允许20%的辍学率,另外将招募96人,最多样本为576人。中心将是随机的:真正的控制,常规方案或MFL干预。真正的对照组将获得有关身体活动的信息,但在试验期间不会包括在计划中;干预将涉及指导者使用教育工具包对一名(或多名)参与者进行培训,使其成为同伴导师;通常的护理小组将按正常情况进行身体活动课程。基线数据将收集身体活动测量值,并在3个月和6个月获得后续测量值。所有参与者将被要求佩戴测量大腿活动的装置(activPAL)7天,然后开始该计划,并在3个月和6个月。该研究的主要目的是调查是否可行的干预措施,并收集所有参与者的中度至剧烈体力活动(MVPA)的数据。从而提供有价值的信息来指导未来的样本量计算,更明确的审判。
■ISRCTN11235176。