Data supporting "Effect of pedometer-based walking interventions on long-term health outcomes: prospective 4-year follow-up of two randomised controlled trials using routine primary care data."

PACE-Lift and PACE-UP are two primary care randomised trials of effective 12-week pedometer-based walking interventions. Results from the 1-year follow-ups and 3-year (PACE-UP) and 4-year (PACE-Lift) have already been published. These data relate to further analyses of both datasets, looking at health outcomes from participants’ routine primary care records.

PACE-Lift recruited 60-75 year olds from three general practices in Berkshire and Oxfordshire from October 2011 to October 2012. Ethical approval was granted by Oxfordshire Research Ethics Committee for up to 12-month follow-up (11/H0606/2). Further ethical approval for 4-year follow-up and primary care download was later granted (14/SC0352). There was a control arm and one intervention arm who received the 12-week PACE-Lift walking intervention.

PACE-UP recruited 45-75 year olds from seven general practices in South West London from October 2012 to November 2013. Ethical approval was granted by London Hampstead Research Ethics Committee, including substantial amendments for the 3-year follow-up and subsequent primary care data download. There was a control arm and two intervention groups who both received the 12-week PACE-UP walking intervention, one group by post and the other with additional practice nurse support. These two intervention groups are combined in the current dataset.

Permission was sought from participants in both studies to access data from their primary care records for up to four years after randomisation.

We identified a priori particular long-term health outcomes in primary care records: non-fatal cardiovascular events, total cardiovascular events (cardiovascular deaths plus non-fatal cardiovascular events), new onset type 2 diabetes, new depression episodes, injurious falls and fractures. We also collected information on the number of primary care consultations and baseline prevalence of prior cardiovascular disease, diabetes and depression.

The dataset available includes variables listed below. There are restrictions on the availability of the data for this study due to the signed consent agreements around data security, which only allow access to external researchers for research monitoring purposes for both trials. Requestors wishing to access the trial data for the purposes of replicating or checking our analysis should contact the SGUL RDM service at researchdata@sgul.ac.uk.

Variables available

Demographics: sex, age, intervention group

Primary care outcomes: Length of follow-up (up to four years). Baseline cardiovascular disease, diabetes and depression. New cardiovascular events, new diagnoses of diabetes, new episodes of depression, falls, fractures and number of consultations during follow-up.