Evaluation of a tailored intervention to improve management of overweight and obesity in primary care: study protocol of a cluster randomised controlled trial
1 Department of Health Sciences, College of Medicine, Biological Sciences and Psychology, University of Leicester, 22-28 Princess Road West, LE1 6TP Leicester, UK
2 Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, Leicester General Hospital, Leicester LE5 4PW, UK
3 Leicester Clinical Trials Unit, College of Medicine, Biological Sciences and Psychology, Leicester General Hospital, Leicester LE5 4PW, UK
4 Department of Mathematical Statistics and Actuarial Sciences,, University of the Free State, P.O. Box 339, Bloemfontein 9300, South Africa
5 Saffron Group Practice, 509 Saffron Lane, Leicester LE2 6UL, UK
6 Public Health Department, Guildhall Road, Northampton NN1 5DN, UK
7 Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre, Postbus 9101, 6500 HB Nijmegen, Netherlands
Trials 2014, 15:82 doi:10.1186/1745-6215-15-82Published: 19 March 2014
In the UK around 22% of men and 24% of women are obese, and there are varying but worrying levels in other European countries. Obesity is a chronic condition that carries an important health risk. National guidelines, for use in England, on the management of people who are overweight or obese have been published by the National Institute for Health and Clinical Excellence (NICE, 2006). NICE recommendations for primary care teams are: determine the degree of overweight and obesity; assess lifestyle, comorbidities and willingness to change; offer multicomponent management of overweight and obesity; referral to external services when appropriate. This study investigates a tailored intervention to improve the implementation of these recommendations by primary care teams.
The study is a cluster randomised controlled trial. Primary care teams will be recruited from the East Midlands of England, and randomised into two study arms: 1) the study group, in which primary care teams are offered a set of tailored interventions to help implement the NICE guidelines for overweight and obesity; or 2) the control group in which primary care teams continue to practice usual care. The primary outcome is the proportion of overweight or obese patients for whom the primary care team adheres to the NICE guidelines. Secondary outcomes include the proportion of patients with a record of lifestyle assessment, referral to external weight loss services, the proportion of obese patients who lose weight during the intervention period, and the mean weight change over the same period.
Although often recommended, the methods of tailoring implementation interventions to account for the determinants of practice are not well developed. This study is part of a programme of studies seeking to develop the methods of tailored implementation.
Current Controlled Trials ISRCTN07457585. Registered 09/08/2013. Randomisation commenced 30/08/2013.