Trial | PACE-Lift | PACE- UP |
Recruitment: October 2011–October 2012 | Recruitment: October 2012–October 2013 | |
12 month follow-up: October 2012-October 2013 | 12 month follow-up: October 2013-October 2014 | |
Study Design | 2-arm parallel design, cluster randomised controlled trial with intervention and control (usual care) arms plus process and qualitative evaluations. Randomised by householda | 3-arm randomised controlled trial with 12 month follow-up and health economic and qualitative evaluations. Randomised by householda |
Aims | To determine if an intervention based on pedometer and accelerometer feedback combined with practice nurse PA consultations in primary care is effective in helping people aged 60–74 years to increase their PA levels over a 3 month period and to maintain any increase over a year | To determine whether inactive patients aged 45–74 years can increase their PA by being given a pedometer with a diary and written guidelines and whether additional individual, tailored, support from a practice nurse increases any benefits over a 3 month period. Main outcome assessed at 12 months. |
Practices: | 3 GP practices in Oxfordshire and Berkshire, UK | 7 GP Practices in South West London, UK |
Practice nurses | 4 | 8 |
Participant eligibility | Able to walk outside and had no contra-indications to increasing PA. | Able to walk outside and had no contraindications to increasing PA and reporting not achieving the current UK PA guidelines |
Age range | 60–75 years | 45–75 years |
Participants | Randomly selected | Randomly selected |
n = 298 (138 m, 160 f) | n = 1023 (367 m, 656 f) | |
Couples 99/298 (33 %) (50 couples, 1 person withdrew) | Couples 209/1023 (20 %) (105 couples, 1 person withdrew) | |
Randomised to: | Randomised to: | |
• Pedometer + accelerometer intervention + nurse support (n = 150) • control (n = 148) | • pedometer intervention + nurse support (n = 346) • postal pedometer intervention (n = 339) • control (n = 338) | |
Intervention | The intervention group received four practice nurse PA consultations over a 12 week period (weeks 1, 3, 7 and 11). These incorporated behaviour change techniques, feedback on pedometer step-counts and accelerometer PA intensity, a PA diary and individually tailored PA plan. | The Intervention group (pedometer plus nurse support) received a pedometer and diary and three individually tailored PA practice nurse consultations (weeks 1, 5, 9). They were supported to follow a 12-week pedometer-based walking programme, using strategies such as self-monitoring, goal-setting, boosting motivation and anticipation of set-backs. |
The accelerometer required downloading in the consultation and graphs of PA intensity were shown to participants. | The pedometer Intervention group were posted out a pedometer, a diary, and written instructions for a 12-week pedometer-based walking programme, based on their own baseline blinded pedometer step-count. Followed-up at 3, 6, 9 and 12 months. There were no meetings with the practice nurse. | |
The control group continued usual PA | The control group continued usual PA | |
In both trials, participants were provided with an individualised PA plan by the practice nurses, starting from where the individual was and increasing both step count and time spent in MVPA | ||
Nurse time commitment | Each consultation was approx 30 min. Including other administrative duties total time approximately 2 h a week per practice | Each consultation was 20–30 min. Including other administrative duties total time approximately 2 h a week per practice |
Outcome assessment | Main outcome assessment (7 day accelerometry to give average daily step-count and average weekly time in moderate to vigorous physical activity) at 3 months (face to face) then postal assessment at 12 months. | Main outcome assessment (7 day accelerometry to give average daily step-count and average weekly time in moderate to vigorous physical activity) at 12 months (face to face) interim postal assessment at 3 months. |
Nurse Consultations | 129/150 (86 %) attended all 4 nurse consultations | 255/346 (74 %) attended all 3 nurse consultations |
Full trial protocol: | Harris et al. (2013a) [17] | Harris et al. (2013b) [18] |
http://www.biomedcentral.com/1471-2458/13/5 | http://www.trialsjournal.com/content/14/1/418 |