Abstract
BackgroundPhysical activity interventions that are targeted at individuals can be effective in encouraging people to be more physically active. However, most such interventions are too long or complex and not scalable to the general population. This trial will test the effectiveness and cost-effectiveness of a very brief physical activity intervention when delivered as part of preventative health checks in primary care (National Health Service (NHS) Health Check).Methods/designThe Very Brief Intervention (VBI) Trial is a two parallel-group, randomised, controlled trial with 1:1 individual allocation and follow-up at 3 months. A total of 1,140 participants will be recruited from 23 primary care practices in the east of England. Participants eligible for an NHS Health Check and who are considered suitable to take part by their doctor and able to provide written informed consent are eligible for the trial. Participants are randomly assigned at the beginning of the NHS Health Check to either 1) the control arm, in which they receive only the NHS Health Check, or 2) the intervention arm, in which they receive the NHS Health Check plus ‘Step It Up’ (a very brief intervention that can be delivered in 5 minutes by nurses and/or healthcare assistants at the end of the Health Check). ‘Step It Up’ includes (1) a face-to-face discussion, including feedback on current activity level, recommendations for physical activity, and information on how to use a pedometer, set step goals, and monitor progress; (2) written material supporting the discussion and tips and links to further resources to help increase physical activity; and (3) a pedometer to wear and a step chart for monitoring progress.The primary outcome is accelerometer counts per minute at 3-month follow-up. Secondary outcomes include the time spent in the different levels of physical activity, self-reported physical activity and economic measures.Trial recruitment is underway.DiscussionThe VBI trial will provide evidence on the effectiveness and cost-effectiveness of the Step It Up intervention delivered during NHS Health Checks and will inform policy decisions about introducing very brief interventions into routine primary care practice.Trial registrationISRCTN Registry, ISRCTN72691150. Registered on 17 July 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1413-2) contains supplementary material, which is available to authorized users.
Highlights
Physical activity interventions that are targeted at individuals can be effective in encouraging people to be more physically active
The financial burden from physical inactivity to the National Health Service (NHS) has been estimated at £1.06 billion annually [1], these costs increase significantly when the wider economic costs are considered [4].The chief medical officer (CMO) for England [1] recommends that adults should take 30 minutes of moderate intensity physical activity (PA), e.g. brisk walking, on at least 5 days per week
We have developed, piloted and evaluated a number of Very brief interventions (VBIs) [10], and a randomised controlled trial (ISRCTN02863077) of three promising VBIs has been undertaken to determine which intervention to take forward for further testing (Pears S, Bijker M, Morton K, Vasconcelos J, Parker RA, Westgate K, et al.: A randomised controlled trial of three very brief interventions for physical activity in primary care, submitted)
Summary
The main aims of the VBI trial are to estimate the effectiveness and the cost-effectiveness of the Step It Up intervention delivered at the end of an NHS Health Check compared with the Health Check alone. With individual randomisation of participants (as opposed to cluster randomisation of practitioners or practices), the risk that some of the content of the very brief intervention may be incorporated into the Health Check and that participants in the control arm may receive some intervention content does exist This did not occur in our trial of a practice nurse-delivered intervention for medication adherence [32]. The trial team brings together expertise in behavioural science, intervention development and evaluation, measurement of PA, medical statistics, health economics, and the design, conduct and analysis of primary care trials. In designing this trial, we have drawn on our previous work and on the guidelines and principles of trial reporting laid out in SPIRIT [34] and CONSORT [35].
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