Title: A multi-centre randomised controlled trial comparing the effectiveness of enhanced motivational interviewing with usual care for reducing cardiovascular risk
Funder: Department of Health and Social Care

Abstract: ABSTRACT Aim: To compare in a RCT the effectiveness and cost-effectiveness of two formats of a motivational interviewing manualised intervention, group and individual, with usual care, in reducing weight and increasing physical activity in people at high risk of cardiovascular disease over a 24 months follow up. Methods: This is a 3 parallel arm multi-centre RCT based in the South London Health Innovation and Education Cluster (HIEC), which includes 11 clinical commissioning groups (CCGs) across South London. Randomisation is stratified by GP borough. Following consent, participants are randomized to usual care, usual care and group motivational interviewing, or usual care and individual motivational interviewing. Participants: Adults aged 40-74 years who screen positive for high CVD risk (Qrisk2 score >20%) and are not known to have cardiovascular disease or to be on the diabetes, kidney, atrial fibrillation or stroke register. Measures: Collected at baseline, 12 and 24 months. Primary outcomes are differences in weight (kilograms) and in physical activity (number of timed steps) between arms at 24 months (interim outcome at 12 months). Secondary outcomes are differences in lipids, blood pressure, HbA1c, CVD risk and in smoking status at 24 months. The EQ-5D will be used to generate quality-adjusted life years. Data analysis: Intention-to-treat statistical analyses will be conducted using STATA 11. Linear mixed models will compare the three treatment groups on all outcome measures at 12 and 24 months accounting for baseline covariates and stratification. Costs and outcomes (primary and QALYs) will be combined in a cost-effectiveness analysis with uncertainty addressed using cost-effectiveness planes and cost-effectiveness acceptability curves. Process Evaluation: We will conduct qualitative and quantitative analyses to identify which components of the intervention were used more often, which were preferred by the healthy lifestyle facilitators and participants and which appeared to be most effective. We will also measure the level of adherence to the intervention by the healthy lifestyle facilitators adapting recent frameworks for measuring competencies to behaviour change techniques. SUMMARY The study is a 3 parallel arm multi-centre RCT for people at high risk for cardiovascular disease (CVD). It will take place within the South London HIEC, which includes 11 clinical commissioning groups across South London, constitutes a population of approximately 3 million residents and is representative of the UK’s highly diverse social, economic and ethnic communities. After informed consent, participants will be randomized to usual care (group 1), usual care and group motivational interviewing (group 2) or usual care and individual motivational interviewing (group 3). *Participants in group 1 will receive usual care from their GPs participating in the study; GP's will be expected to follow their local care pathway for those who have a CVD risk score >20%. *Participants in group 2 will receive usual care and group motivational interviewing. The programme will consist of 10 sessions lasting 120 minutes each over 12 months delivered by healthy lifestyle facilitators trained in behaviour change techniques. The intensive phase will be 6 weekly sessions. The maintenance phase will be 4 sessions delivered at 3, 6, 9 and 12 months. The contents will focus on early setting of goals and of maintenance techniques using the group environment to facilitate change. We will include visual aids, patient testimonials, behavioural surveys and e-technology tools to enhance self-monitoring and feedback of healthier behaviours (mobile texts, social networking sites), pedometers. *Participants in group 3 will receive usual care and individual motivational interviewing. This will have the same components as group 2 but delivered individually. Sessions will last 40 minutes. Intention-to-treat statistical analyses will be conducted using STATA 11. Linear mixed models will compare the three treatment groups on all outcome measures at 12 and 24 months accounting for baseline covariates and stratification. Costs and outcomes (primary and QALYs) will be combined in a cost effectiveness analysis with uncertainty addressed using cost-effectiveness planes and cost-effectiveness acceptability curves. SAMPLE GROUP The participants will include adults age 40-74 years who screen positive for high CVD risk (Qrisk2 score >20%), defined as having a 20% or higher chance of having a fatal or non-fatal cardiovascular event over the next ten years and not known to have cardiovascular disease or to be on the diabetes, kidney, atrial fibrillation or stroke register. We have calculated that there will be approximately 11,350 individuals who will have a CVD risk score > 20%. Assuming a conservative participation rate of 25% into this study the target population is large enough to achieve our sample size of ~1,700 participants. STUDY OUTCOMES The primary outcomes are change in weight and physical activity between baseline and follow-up. Weight will be measured in kilograms using Tanita scales and physical activity as average number of steps per day over one week using the actigraph GT3X+ accelerometer. The changes in weight and number of steps from baseline will be compared between the two treatment groups. The secondary outcomes to be measured are differences in: lipids, blood pressure, HbA1c, and CVD risk and in smoking status at 24 months. We will also be measuring participants alcohol intake (using the Alcohol Use Disorders Identification Test), participants health beliefs about diet, exercise, perceptions of risk for developing CVD and related conditions (measured by the Brief Illness Perception Questionnaire adapted for perception of risk), participants mood (using the 9-item Patient Health Questionnaire) because depression is associated with worse outcomes in CVD, participants smoking status (how many cigarettes/day or if ex-smoker for how many years or never smoked) and participants dietary intake (assessed using a standardized multiple-pass 24-hour dietary recall and photographs to estimate daily calorie intake).

Lay abstract: The number of adults who do not perform the recommended levels of physical activity (a minimum of 30 minutes of walking a day) and who have unhealthy diets is increasing. This lifestyle increases the risk of heart disease, stroke and diabetes. Motivational interviewing is a type of communication style and talking therapy to help people become more confident, willing and committed to making changes to their lifestyles. The effects can be short-lived so people can find themselves returning to their old habits. We want to find out if adding other strategies to motivational interviewing, such as counting the number of step we walk (pedometers), recognising our own unhelpful thinking patterns, and making the most of the support from family and friends, could help people who are at high risk of developing heart disease to make healthier lifestyle changes, and then stick to these for the next 2 years. Our aim is to help people reduce their weight and increase normal activities such as walking and taking the stairs. We will invite people who have had the NHS Health Check and found to be at high risk of developing heart disease. Those who consent will have an equal or random chance to be allocated to one of 3 treatment groups-either a group version of motivational interviewing, an individual version of motivational interviewing or the usual care from their GP. The sessions will be held in community halls or health centres. There will be 10 sessions spread over 1 year. The first 6 sessions will be weekly and the last 4 will be every 3 months. The sessions will be led by a healthy lifestyle facilitator who will be trained to a high standard in motivational interviewing and the additional techniques. We will measure changes in weight, diet and physical activity as well as emotional factors. We are looking for medium to small changes in weight and activity because we want to encourage participants to make small changes that they believe they can stick to and also because small changes for the individual can add up to big changes for the whole population. As a result of the small changes, we will need a large sample of 1,700 participants.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CARDIOVASCULAR