Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial.
Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial.
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DOI：
10.1186/1471-2458-13-467
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发表时间：
2013-05-14
影响因子：
4.5
通讯作者：
Tango T
中科院分区：
文献类型：
--
作者：
Adachi M;Yamaoka K;Watanabe M;Nishikawa M;Kobayashi I;Hida E;Tango T
2型糖尿病的患病率在全球范围内不断上升，全球平均空腹血糖水平也在上升。本研究旨在评估由注册营养师在初级保健临床环境中提供的结构化的基于个人的生活方式教育（思乐）计划对降低2型糖尿病患者血红蛋白A1 c（HbA 1c）水平的有效性。这是一项为期6个月的前瞻性分组随机对照试验，在初级保健环境中进行，在实践水平进行随机化。日本神奈川县20家诊所的20名全科医生参与其中。193名在医疗诊所接受治疗的2型糖尿病和HbA 1c ≥6.5%的成人（51%男性，平均年龄61.3岁）参与者。在6个月的研究期间，通过4次培训注册营养师的会议实施思乐计划。结果进行了比较，与对照组谁接受常规护理。主要终点是6个月时HbA 1c水平较基线的变化。次要终点是6个月时空腹血糖、血脂、血压、BMI、能量和营养摄入量（全天和每餐）较基线的变化。进行意向治疗分析。混合效应线性模型用于检查治疗的效果。干预组（n = 100）和对照组（n = 93）6个月时HbA 1c较基线的平均变化分别为降低0.7%和0.2%（差异为-0.5%，95%CI：-0.2%至-0.8%，p = 0.004）。校正基线值和其他因素后，差异仍有显著性（p = 0.003 ~ 0.011）。与对照组相比，干预组晚餐时的平均能量摄入量显著降低，全天、早餐和午餐的平均蔬菜摄入量显著增加，如粗模型和调整模型所示。在其他次要终点中观察到改善趋势，但改善不具有统计学显著性。这些结果得到了多项敏感性分析的证实。在初级保健环境中为2型糖尿病患者提供的思乐计划比常规糖尿病护理和教育更能改善HbA 1c水平。http：//UMIN000004049
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. 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. 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. 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. http://UMIN000004049
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DOI：
10.1016/j.jclinepi.2010.03.004
发表时间：
2010-01-01
期刊：
Open medicine : a peer-reviewed, independent, open-access journal
影响因子：
--
作者：
Schulz, Kenneth F;Altman, Douglas G;Moher, David
通讯作者：
Moher, David
影响因子：
3.5
作者：
Deakin, T. A.;Cade, J. E.;Greenwood, D. C.
通讯作者：
Greenwood, D. C.
影响因子：
9.8
作者：
Lindsay, JR;McKillop, AM;O'Harte, FPM
通讯作者：
O'Harte, FPM
影响因子：
5.1
作者：
Goderis, Geert;Borgermans, Liesbeth;Heyrman, Jan
通讯作者：
Heyrman, Jan
影响因子：
16.2
作者：
Davis, Richard M.;Hitch, Angela D.;Mayer-Davis, Elizabeth J.
通讯作者：
Mayer-Davis, Elizabeth J.