Abstract

BACKGROUND: Interventions 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/DESIGN: Individuals 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. DISCUSSION: This 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 REGISTRATION: This trial is registered with the ISRCTN registry (identifier: ISRCTN84864870, registered 15 May 2012).