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.
Keywords: CARDIOVASCULAR DISEASE; COGNITIVE–BEHAVIOURAL THERAPY; LIFESTYLE INTERVENTION; MOTIVATIONAL INTERVIEWING; PHYSICAL ACTIVITY; PRIMARY HEALTH CARE; WEIGHT LOSS.
People who have a high risk of heart disease can reduce this risk by changing their lifestyles, such as by improving their diets and increasing their physical activity levels. However, there is no good evidence on how best to support people to change and then maintain healthier lifestyles. It is thought that support from others might be helpful. An intervention based on two talking therapies, called motivational interviewing and cognitive–behavioural therapy, to help people make a commitment to living healthier lives was developed. People from the local community with a health-related background were recruited and trained in these skills. Then general practitioners invited patients on their register who were at high risk of heart disease to participate. Those patients who replied and met the study criteria were randomly allocated to one of three arms. Participants received either group- or individual-based intensive lifestyle sessions or usual care. Those who were randomised to the lifestyle course were offered 10 sessions of therapy over 12 months by lifestyle trainers. Two years later, it was found that there were no differences in weight or physical activity levels between the three arms. The lifestyle interventions were not cost-effective compared with usual care. When the possible explanations were studied, it was found that those who could have benefited the most from the therapy (such as those who were most overweight, those from poorer backgrounds and those who were of African Caribbean ethnicity) were less likely to participate. Whether or not the skills of the therapists made a difference could not be properly assessed. Sometimes, patients and their doctors were not sure why they were invited. Future research should focus on people who have lifestyles that can be changed (e.g. more overweight individuals with unhealthy diets), on finding ways of improving the quality of the intervention and on ensuring that patients have more information.