ObjectiveThe epidemic of obesity is contributing to the increasing prevalence of people at high risk of cardiovascular disease (CVD), negating the medical advances in reducing CVD mortality. We compared the clinical and cost-effectiveness of an intensive lifestyle intervention consisting of enhanced motivational interviewing in reducing weight and increasing physical activity for patients at high risk of CVD.MethodsA three-arm, single-blind, parallel-group randomised controlled trial was conducted in consenting primary care centres in south London. We recruited patients aged 40–74 years with a QRisk2 score ≥20.0%, which indicates the probability of having a CVD event in the next 10 years. The intervention was enhanced motivational interviewing which included additional behaviour change techniques and was delivered by health trainers in 10 sessions over 1 year, in either group (n=697) or individual (n=523) format. The third arm received usual care (UC; n=522). The primary outcomes were physical activity (mean steps/day) and weight (kg). Secondary outcomes were changes in low-density lipoprotein cholesterol and CVD risk score. We estimated the relative cost-effectiveness of each intervention.ResultsAt 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI −288.00 to 147.90 and mean difference=7.24 steps, 95% CI −224.01 to 238.50, respectively), reducing weight (mean difference=−0.03 kg, 95% CI −0.49 to 0.44 and mean difference=−0.42 kg, 95% CI −0.93 to 0.09, respectively) or improving any secondary outcomes. The group and individual interventions were not cost-effective at conventional thresholds.ConclusionsEnhancing motivational interviewing with additional behaviour change techniques was not effective in reducing weight or increasing physical activity in those at high CVD risk.

Over-identification of depression by PHQ-9 in T2DM may be driven by presence of symptoms in keeping with an organic origin.

Background Motivational 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. Objectives The 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. Design This was a three-arm, single-blind, parallel randomised controlled trial. Setting A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited. Participants A total of 1742 participants aged 40–74 years with a ≥ 20.0% risk of a CVD event in the following 10 years were randomised. Interventions The 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. Randomisation Simple 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 measures The 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. Results The 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. Conclusions Enhanced 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 registration Current Controlled Trials ISRCTN84864870. Funding This 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.

BackgroundInterventions targeting multiple risk factors for cardiovascular disease (CVD), including poor diet and physical inactivity, are more effective than interventions targeting a single risk factor. A motivational interviewing (MI) intervention can provide modest dietary improvements and physical activity increases, while adding cognitive behaviour therapy (CBT) skills may enhance the effects of MI. We designed a randomised controlled trial (RCT) to examine whether specific behaviour change techniques integrating MI and CBT result in favourable changes in weight and physical activity in those at high risk of CVD. A group and individual intervention will be compared to usual care. A group intervention offers potential benefits from social support and may be more cost effective.Methods/DesignIndividuals aged between 40 and 74 years in 11 South London Clinical Commissioning Groups who are at high risk of developing CVD (≥20%) in the next 10 years will be recruited. A sample of 1,704 participants will be randomised to receive the enhanced MI intervention, delivered by trained healthy lifestyle facilitators (HLFs), in group or individual formats, in 10 sessions (plus an introductory session) over one year, or usual care. Randomisation will be conducted by King’s College London Clinical Trials Unit and researchers collecting outcome data will be blinded to treatment allocation. At 12-month and 24-month follow-up assessments, primary outcomes will be change in weight and physical activity (average steps per day). Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. Incidence of CVD events since baseline will be recorded. A process evaluation will be conducted to evaluate factors which impact on delivery, adherence and outcome. An economic evaluation will estimate relative cost-effectiveness of each type of intervention delivery.DiscussionThis RCT assesses the effectiveness of a healthy lifestyle intervention for people at high risk of CVD. Benefits of the study include the ethnic and socioeconomic diversity of the study population and that, via social support within the group setting and long-term follow-up period, the intervention offers the potential to support maintenance of a healthy lifestyle.Trial registrationThis trial is registered with the ISRCTN registry (identifier: ISRCTN84864870, registered 15 May 2012).

The distressing experience of GID symptoms are compounded by a delay in validating symptoms and lack of coherent understanding. More knowledge of GID is needed by health professionals to speed up diagnosis and offer more coherent information. The psychological impact of a GID diagnosis should be acknowledged early to help facilitate adjustment.