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Randomized Controlled Trial
. 2013 May 14:13:467.
doi: 10.1186/1471-2458-13-467.

Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial

Misa Adachi  1 , Kazue Yamaoka, Mariko Watanabe, Masako Nishikawa, Itsuro Kobayashi, Eisuke Hida, Toshiro Tango
Affiliations
Randomized Controlled Trial

Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial

Misa Adachi et al. BMC Public Health. .

Abstract

Background: The prevalence of type 2 diabetes is rising worldwide, as has been the global mean fasting plasma glucose level. This study aimed to evaluate the effectiveness of a structured individual-based lifestyle education (SILE) program to reduce the hemoglobin A1c (HbA1c) level in type 2 diabetes patients delivered by registered dietitians in primary care clinical settings.

Methods: This was a 6-month prospective cluster randomized controlled trial in a primary care setting with randomization at the practice level. Twenty general practitioners in 20 clinics in Kanagawa prefecture, Japan, were involved. 193 adults (51% men, mean age 61.3 years) with type 2 diabetes and HbA1c ≥6.5% who received treatment in medical clinics were the participants. A SILE program was implemented through 4 sessions with trained registered dietitians during the 6-month study period. Results were compared with those of a control group who received usual care. The primary endpoint was the change in HbA1c levels at 6 months from baseline. Secondary endpoints were the changes at 6 months from baseline in fasting plasma glucose, lipid profile, blood pressure, BMI, energy, and nutrient intakes (whole day and each meal). Intention-to-treat analysis was conducted. Mixed-effects linear models were used to examine the effects of the treatment.

Results: The mean change at 6 months from baseline in HbA1c was a 0.7% decrease in the intervention group (n = 100) and a 0.2% decrease in the control group (n = 93) (difference -0.5%, 95%CI: -0.2% to -0.8%, p = 0.004). After adjusting for baseline values and other factors, the difference was still significant (p = 0.003 ~ 0.011). The intervention group had a significantly greater decrease in mean energy intake at dinner compared with the control group and a greater increase in mean vegetable intake for the whole day, breakfast, and lunch as shown in crude and adjusted models. A tendency toward improvement was observed in the other secondary endpoints but the improvement was not statistically significant. These results were confirmed by several sensitivity analyses.

Conclusions: The SILE program that was provided in primary care settings for patients with type 2 diabetes resulted in greater improvement in HbA1c levels than usual diabetes care and education.

Trial registration: http://UMIN000004049.

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Figures

Figure 1
Figure 1
Flow diagram of progress of clusters and individuals through phases of the randomized trial.
Figure 2
Figure 2
Mean change with standard error at 6 months from baseline in vegetable intake (g).
See this image and copyright information in PMC

References

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