Abstract
BackgroundSystematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. A randomised controlled trial is needed to assess whether providing motivational interviewing, three months after giving initial advice, sustains physical activity levels in those who recently became physically active. This paper reports the results of an internal pilot study designed to test the feasibility of the study in terms of recruitment, per protocol delivery of the intervention and retention at three months.MethodsParticipants were: aged 40-64 years; resident in deprived areas of Sheffield, UK; and, had recently become physically active as a result of using a brief intervention following an invitation from a mass mailout. Interventions: Motivational Interviewing 'boosters' aimed at sustaining change in physical activity status delivered face-to-face or over the telephone compared with no further intervention. Outcomes of the feasibility study: recruitment of 60 participants from mailout of 3,300; retention of 45 participants with 3-month follow-up accelerometry measurements; 70% of those randomised to boosters receiving intervention per protocol. Sample size and power were recalculated using the accelerometry data collected.ResultsForty-seven participants were randomised (78% of the feasibility target); 37 participants were retained at three months, 29 with at least four days of accelerometry data (64% of the feasibility target); 79% of those allocated boosters received them per protocol (surpassing the feasibility target). The proposed sample size of 600 was confirmed as appropriate and power is expected to be sufficient to detect a difference between groups.ConclusionsThe main study will continue with the original recruitment target of 600 participants but to ensure feasibility, it is necessary to increase recruitment and improve the numbers of those followed-up who have evaluable data. Strategies will include increasing the number of initial invitations sent out and improving the training of research assistants and participants in the positioning of the accelerometer.Trial RegistrationISRCTN: ISRCTN56495859, ClinicalTrials (NCT): NCT00836459
Highlights
Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people
A recent systematic review established that brief interventions in primary care can increase physical activity levels [12] and identified a sufficient evidence base for the UK National Institute of Health and Clinical Excellence (NICE) to recommend their use [13]
This paper only describes the results of the internal pilot and feasibility study
Summary
Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. The primary aim of intervention programmes is to encourage participants to increase their activity sufficiently to meet the current recommended levels for health benefit [11]. A recent systematic review established that brief interventions in primary care can increase physical activity levels [12] and identified a sufficient evidence base for the UK National Institute of Health and Clinical Excellence (NICE) to recommend their use [13]. The review, identified specific evidence gaps, with regard to the value of follow up beyond three months for the longer term maintenance of physical activity. Maintenance of increased physical activity levels is essential to achieve the reported health benefits
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