Effects of a lifestyle program in subjects with Impaired Fasting XXXX , a pragmatic cluster-randomized controlled trial.

@entity413 @entity1 @entity164 @entity6
BACKGROUND: The worldwide epidemic of @entity164 2 @entity6 (T2DM) underlines the need for @entity6 prevention strategies. In this study the feasibility and effectiveness of a nurse led lifestyle program for subjects with impaired fasting @entity413 (IFG) is assessed. METHODS: A cluster randomized clinical trial in 26 primary care practices in the Netherlands included 366 @entity1 older than 45  years with newly diagnosed IFG and motivated to change their lifestyle (intervention group, n   =   197; usual care group, n   =   169). The one-year intervention, consisting of four to five individual nurse-led consultations, was directed at improving physical activity and dietary habits. The primary outcome measure was body mass index (BMI). Linear and logistic multilevel analyses and a process evaluation were performed. RESULTS: Both groups showed small reductions in BMI at 1 and 2  years, but differences between groups were not significant. At both 1 and 2-year follow-up the number of @entity1 physically active for at least 30  minutes at least five days a week was significantly improved in the intervention group compared to the usual care group (intervention group vs. usual care group: OR1year   =   3.53; 95  % CI   =   1.69-7.37 and OR2years   =   1.97; 95  % CI   =   1.22-3.20, respectively). The total drop-out rate was 24  %. Process evaluation revealed that @entity1 in the intervention group received fewer consultations than advised, while some practice nurses and @entity1 considered the RM protocol too intensive. CONCLUSIONS: This relatively simple lifestyle program in subjects with IFG resulted in a significant improvement in reported physical activity, but not in BMI. Despite its simplicity, some @entity1 still considered the intervention too intensive. This viewpoint could be related to poor motivation and an absence of disease burden due to IFG, such that @entity1 do not feel a need for behavioural change. Although the intervention provided some benefit, its wider use cannot be advised. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41209683 , date of registration 16/10/2013h   .
