Background: The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5 minutes) pedometer-based intervention (‘Step It Up’) delivered as part of National Health Service (NHS) Health Checks in primary care. Methods and findings: The VBI Trial was a two parallel-group, randomised controlled trial with three-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40-74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between Oct 1, 2014 and Dec 31, 2015 to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received ‘Step It Up’: a five-minute face-to-face discussion, written materials, pedometer and step chart. The primary outcome was accelerometer-based physical activity volume at three-month follow-up adjusted for sex, five-year age group and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants’ mean age was 56 years, two-thirds were female, they were predominantly white and two-thirds were in paid employment. The primary outcome was available in N=859 (85.3%) participants. There was no significant between-group difference in activity volume at three months (adjusted intervention effect 8.8 counts per minute; 95% CI -18.7, 36.3; p=0.53). We found no significant between-group differences in the secondary outcomes of accelerometer-derived step counts per day and time spent in moderate to vigorous, vigorous and moderate intensity activity; and self-reported total physical activity, home-based, work-based, leisure based and commuting physical activity, and screen or TV time. 97% (491/505) of intervention participants received the ‘Step it Up’ intervention. Analysis of 37 intervention consultations showed that 60% of ‘Step it Up’ components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1000 steps increase per day was £96, and to society £239. Adverse events were reported by five intervention participants (of which two were serious), and five control participants (of which two were serious). The study’s limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment. Conclusions: In this large well-conducted trial we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at three-month follow-up. Trial registration: Current Controlled Trials (ISRCTN72691150).
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)