Evaluation of a tailored intervention to improve management of overweight and obesity in primary care: study protocol of a cluster randomised controlled trial

Abstract

BackgroundIn 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.Methods/DesignThe 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.DiscussionAlthough 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.Trial registrationCurrent Controlled Trials ISRCTN07457585. Registered 09/08/2013. Randomisation commenced 30/08/2013.

Stakeholders’ contributions to tailored implementation programs: an observational study of group interview methods

“…Our study used brainstorming, which is based on the assumption that with increasing volume of strategies the number of “good strategies” will also increase [ 4 ]. The ultimate proof for this will be provided by the five trials [ 9 - 13 ], which examine the processes and outcomes of implementation programs that were based on the suggestions made in the group sessions. We felt that it is difficult to assess the “validity” of the strategies generated in the group interviews as we could not think of a meaningful reference for such assessment.…”

“…In this study, we focused on the subsequent phase, which aimed at generating strategies for improving healthcare practice. In the final phase of the TICD project, tailored interventions will be evaluated in cluster randomized trials [ 9 - 13 ].…”

Interventions targeted at primary care practitioners to improve the identification and referral of patients with co-morbid obesity: a realist review protocol

“…Both of these issues are relevant in this review. First, as noted above, we know that two systematic reviews found very few interventions targeted at primary care practitioners to improve the screening and referral of adults with obesity [ 25 , 27 ], though these are now a number of years old, and this is clearly an area where new research is being produced on a regular basis [ 17 , 37 ]. Second, we know from similar research into interventions targeted at primary care practitioners to improve identification and referral in sensitive areas - in this case intimate partner violence screening [ 38 ] - that there are a number of different potential intervention components (for example effective protocols, ongoing training, feedback, improving access to support), which may in turn have different mechanisms underpinning them (for example practitioner self-efficacy, trust and confidence in the service, accepting responsibility).…”

Impact of a tailored program on the implementation of evidence-based recommendations for multimorbid patients with polypharmacy in primary care practices—results of a cluster-randomized controlled trial

“…This study is part of the “Tailoring Interventions for Chronic Diseases” (TICD) project [37], during which five tailored programs have been developed and evaluated in randomized controlled trials according to a coordinated research plan [38–42]. The concept of tailoring used in TICD has been described elsewhere [43].…”