title: Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial.
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.
  
  
  BACKGROUND
  http://UMIN000004049.
authors.affiliation: Nutrition Support Network LLC, 2-2-4 Wakamatu, Sagamihara, Kanagawa 252-0334, Japan.
authors.forename: Misa
authors.initials: M
authors.lastname: Adachi
authors.forename: Kazue
authors.initials: K
authors.lastname: Yamaoka
authors.forename: Mariko
authors.initials: M
authors.lastname: Watanabe
authors.forename: Masako
authors.initials: M
authors.lastname: Nishikawa
authors.forename: Itsuro
authors.initials: I
authors.lastname: Kobayashi
authors.forename: Eisuke
authors.initials: E
authors.lastname: Hida
authors.forename: Toshiro
authors.initials: T
authors.lastname: Tango
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism*; D001794:Blood Pressure; D015992:Body Mass Index; D016000:Cluster Analysis; D035061:Control Groups; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D002149:Energy Intake; D005260:Female; D005951:Glucose Tolerance Test; D006442:Glycated Hemoglobin / Q000032:analysis / Q000378:metabolism; D006801:Humans; D007564:Japan; D008019:Life Style; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009313:National Health Programs; D010353:Patient Education as Topic / Q000379:methods*; D011320:Primary Health Care / Q000706:statistics & numerical data*; D011446:Prospective Studies; D012648:Self Care / Q000379:methods; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin