• Khalida Ismail, Daniel Stahl, Adam Bayley, Katherine Twist, Kurtis Stewart, Katie Ridge, Emma Britneff, Mark Ashworth, Nicole de Zoysa, Jennifer Rundle, Derek Cook, Peter Whincup, Janet Treasure, Paul McCrone, Anne Greenough, and Kirsty Winkley.
• Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
• Health Technol Assess. 2019 Dec 1; 23 (69): 1-144.

BackgroundMotivational interviewing (MI) enhanced with behaviour change techniques (BCTs) and deployed by health trainers targeting multiple risk factors for cardiovascular disease (CVD) may be more effective than interventions targeting a single risk factor.ObjectivesThe clinical effectiveness and cost-effectiveness of an enhanced lifestyle motivational interviewing intervention for patients at high risk of CVD in group settings versus individual settings and usual care (UC) in reducing weight and increasing physical activity (PA) were tested.DesignThis was a three-arm, single-blind, parallel randomised controlled trial.SettingA total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited.ParticipantsA total of 1742 participants aged 40-74 years with a ≥ 20.0% risk of a CVD event in the following 10 years were randomised.InterventionsThe intervention was designed to integrate MI and cognitive-behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators in 10 sessions over 1 year, in group or individual format. The control group received UC.RandomisationSimple randomisation was used with computer-generated randomisation blocks. In each block, 10 participants were randomised to the group, individual or UC arm in a 4 : 3 : 3 ratio. Researchers were blind to the allocation.Main Outcome MeasuresThe primary outcomes are change in weight (kg) from baseline and change in PA (average number of steps per day over 1 week) from baseline at the 24-month follow-up, with an interim follow-up at 12 months. An economic evaluation estimates the relative cost-effectiveness of each intervention. Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score.ResultsThe mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white. At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI) -288 to 147.9 steps, and mean 7.24 steps, 95% CI -224.01 to 238.5 steps, respectively] or in reducing weight (mean -0.03 kg, 95% CI -0.49 to 0.44 kg, and mean -0.42 kg, 95% CI -0.93 to 0.09 kg, respectively). At the 12-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA (mean 131.1 steps, 95% CI -85.28 to 347.48 steps, and mean 210.22 steps, 95% CI -19.46 to 439.91 steps, respectively), but there were reductions in weight for the group and individual intervention arms compared with UC (mean -0.52 kg, 95% CI -0.90 to -0.13 kg, and mean -0.55 kg, 95% CI -0.95 to -0.14 kg, respectively). The group intervention arm was not more effective than the individual intervention arm in improving outcomes at either follow-up point. The group and individual interventions were not cost-effective.ConclusionsEnhanced MI, in group or individual formats, targeted at members of the general population with high CVD risk is not effective in reducing weight or increasing PA compared with UC. Future work should focus on ensuring objective evidence of high competency in BCTs, identifying those with modifiable factors for CVD risk and improving engagement of patients and primary care.Trial RegistrationCurrent Controlled Trials ISRCTN84864870.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 69. See the NIHR Journals Library website for further project information. This research was part-funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

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