Researchers evaluated the effectiveness of structured individual-based lifestyle education (SILE) as a means to decrease the hemoglobin A1c (HbA1c) in type 2 diabetics. The program included lifestyle changes and diet assistance provided by registered dietitians in a primary care settings.
The SILE trial gathered its study population by randomly selecting participants in a cluster fashion and following them prospectively for over 6-months in a primary care setting with randomization at the practice level. The study used 20 general practitioners in 20 clinics, 193 type 2 diabetic adults (51% men, mean age 61.3 years) with an HbA1c ≥6.5%.
The participating adults in the study received the SILE program through 4 sessions with trained registered dietitians during the 6-month trial. All results from the SILE group were compared with a control group who received only usual care. The primary endpoint in the study was to measure the improvement or decline in HbA1c after a 6 months period from baseline. Secondary endpoints were the changes from baseline in fasting plasma glucose, lipid profile, blood pressure, BMI, energy, and nutrient intakes (whole day and each meal) over the 6 month trial period. The statistical test used to quantify the result from this study was an intention-to-treat analysis. A mixed-effects linear model was also implemented to observe the effects of the SILE treatment over the duration of the study.
Results from the trial indicated that the mean change over the 6 month period from baseline in HbA1c was a 0.7% decrease in the intervention group and a 0.2% decrease in the control group. After these results were adjusted for baseline values and other factors the difference was still significant. The intervention group had less mean energy intake at dinner in comparison to the control group as well as a greater increase in overall vegetable intake. The following was also true for breakfast, lunch and snack foods.
These results were also confirmed by a sensitivity analyses. A tendency toward improvement was observed in the other secondary endpoints but the improvement was not statistically significant. Researchers concluded that the SILE program in primary care settings for type 2 diabetics resulted in better improvement in HbA1c levels compared to standard diabetes care and education.
Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial." Teikyo University, Graduate School of Public Health, 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605, Japan. BioMed Central Ltd , 15 May 2013. Web. 7 Jun 2013. <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3658890/>.