'On Your Feet to Earn Your Seat': update to randomised controlled trial protocol

BACKGROUND: This update describes changes to procedures for our randomised controlled trial of 'On Your Feet to Earn Your Seat', a habit-based intervention to reduce sedentary behaviour in older adults. Some of the amendments have arisen from the addition of new sites, each offering different possibilities and constraints for study procedures. Others have been made in response to problems encountered in administering intended recruitment procedures at the London sites described in our original protocol. All changes have received ethics and governance clearance, and were made before or during data collection and prior to analyses.

METHODS/DESIGN: Five non-London UK NHS-based sites (three general practices, one hospital, one NHS Foundation Trust) have been added to the study, each employing locally-tailored variations of recruitment and data collection procedures followed at the London sites. In contrast to the London sites, accelerometry data are not being collected nor are shopping vouchers being given to participants at the new sites. Data collection was delayed at the London sites because of technical difficulties in contacting participants. Subsequently, a below-target sample size was achieved at the London sites (n = 23), and recruitment rates cannot be estimated. Additionally, the physical inactivity inclusion criterion (i.e., <30 consecutive minutes of leisure time activity) has been removed from all sites, because we found that participants at the London sites meeting this criterion at consent subsequently reported activity above this threshold at the baseline assessment.

CONCLUSION: This is primarily a feasibility trial. The addition of new sites, each employing different study procedures, offers the opportunity to assess the feasibility of alternative recruitment and data collection methods, so enriching the informational value of our analyses of primary outcomes. Recruitment has finished, and the coincidence of a small sample at the London sites with addition of new sites has ensured a final sample size similar to our original target.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN47901994 (registration date: 16th January 2014).