Extrait

Background and study aims 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. These lifestyles increase 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 such as stopping and starting smoking. 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. The aim would be to reduce weight and increase normal activities such as walking and taking the stairs. 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. Who can participate? Participants will be adults age 40-74 years who screen positive for high cardiovascular disease risk on the NHS Health Checks, 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. Participants can only enter the study if they are fluent in conversational English; permanent residents and planning to stay in the UK at least ¾ of year. We will not accept participants who already have cardiovascular disease; severe mental illness such as psychosis, learning disability, dementia and cognitive impairment; are registered blind; housebound or resident in nursing home; unable to move about independently; more than three falls in past year; pregnant, advanced cancer; morbid obesity or are currently participation in a weight loss programme. When in doubt we will seek the general practitioner (GP) opinion and approval. What does the study involve? After they consent to take part, participants will be randomised (meaning they have equal chance of being assigned to any of the three groups) to one of three groups: usual care, usual care and individual motivational interviewing, usual care and group motivational interviewing. We will compare each of the three groups in terms of changes in weight, diet and physical activity of the participants, as well as emotional factors. Participants will receive different treatment depending on what group they are randomised to. Patients in usual care will receive the usual care from their GP. Participants in usual care and group enhanced motivational interviewing will attend 10 sessions lasting 90 minutes each over 12 months delivered by health trainers 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. Participants in usual care and individual enhanced motivational interviewing will experience the same treatment as participants in the usual care and group enhanced motivational interviewing but the intervention will be delivered individually. Sessions will last 30 minutes. What are the possible benefits and risks of participating? There are potential health benefits for all participants taking part in the study such as weight reduction, increased exercise, lowering cardiovascular disease (CVD) risk, as it is known that participation in research is associated with better outcomes. All participants are contributing to research in which results can help in the development of interventions to improve outcomes for people at risk of CVD. Within the group intervention participants have the potential benefit of learning and social support from others. In general regular physical activity is associated with better health outcomes. Although sudden increases in physical activity in people who are generally inactive is associated with a higher risk of heart attack and/or injuries, one of the intervention techniques in this study is to deliver the message that physical activity should be increased in a gradual manner rather than suddenly. We will be discouraging sudden changes to lifestyles. We consider this risk to be small and it will be minimized by excluding participants who have existing cardiovascular disease. There is a small risk that some participants may experience rapid weight loss, but importantly our intervention is based on healthier diets, and gradual and sustainable weight loss as opposed to commercial weight loss programmes. Where is the study run from? The study will take place within The South London Health Innovation and Education Cluster (HIEC), which includes 11 primary care trusts (PCT) 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. The primary care trusts are: Bromley, Greenwich, Southwark, Sutton & Merton, Richmond & Twickenham, Lewisham, Bexley, Kingston, Wandsworth, Croydon and Lambeth. When is the study starting and how long is it expected to run for? The anticipated start date for the study is currently 1st September 2012. We are scheduled to recruit participants for 1 year. Who is funding the study? The study is funded by the National Institute for Health and Research Health Technology Assessment Programme. Who is the main contact? Professor Khalida Ismail [email protected]

Critère d'inclusion

• Cardiovascular Disease (CVD)

Liens

• ictrp
• isrctn