Adachi Misa, Yamaoka Kazue, Watanabe Mariko, Nemoto Asuka, Tango Toshiro
Nutrition Support Network LLC, Kanagawa, Japan.
Teikyo University Graduate School of Public Health, Tokyo, Japan.
BMJ Open. 2017 Oct 24;7(10):e017838. doi: 10.1136/bmjopen-2017-017838.
Type 2 diabetes (T2D) is a significant problem, and lifestyle modifications including self-management are important. We have developed a structured individual-based lifestyle education (SILE) programme for T2D. With attention now being paid to techniques to change behaviour, we recently developed a behavioural type-specific SILE (BETSILE) programme. We aimed to evaluate the effectiveness of the BETSILE programme compared with the SILE programme for reducing glycated haemoglobin (HbA1c) in patients with T2D and special behavioural types by a cluster randomised controlled trial.
This is a 6-month cluster randomised controlled trial with two intervention arms (BETSILE vs SILE) provided in a medical care setting by randomising registered dietitians for patients with T2D aged 20-79 years. Patients' behavioural types were classified into four types (BT1 to BT4) using an assessment sheet. We will perform independent trials for BT1 and BT2. The primary endpoint is a change from the baseline HbA1c value at 6 months. Differences between the SILE and BETSILE groups will be primarily analysed following the intention-to-treat principle. Crude and multivariate adjusted effects will be examined after adjusting for covariates, using a general linear mixed-effects model for continuous variables and a logistic regression mixed-effects model for dichotomous variables. Sample sizes needed were calculated assuming effect sizes of 0.42 and 0.33 for BT1 and BT2, respectively, an intraclass correlation of 0.02, a significance level of 5% (two-sided), a power of 80%, and equal allocation of clusters to the two arms, with each cluster having three BT1 patients for the SILE and BETSILE arms and six BT2 patients for the SILE and BETSILE arms. We will need 16 dietitians for each arm, and a total 288 patients will be required.
This study has been approved by the Medical Ethical Committee of Teikyo University (No.15-222). Findings will be disseminated widely through peer-reviewed publications, etc.
UMIN 000023087; Pre-results.
2型糖尿病（T2D）是一个重大问题，包括自我管理在内的生活方式改变很重要。我们为T2D患者开发了一种结构化的基于个体的生活方式教育（SILE）计划。鉴于现在人们对改变行为的技巧予以关注，我们最近开发了一种针对特定行为类型的SILE（BETSILE）计划。我们旨在通过一项整群随机对照试验，评估BETSILE计划与SILE计划相比，对降低T2D患者及特殊行为类型患者糖化血红蛋白（HbA1c）水平的有效性。
这是一项为期6个月的整群随机对照试验，在医疗环境中设置两个干预组（BETSILE组与SILE组），通过随机分配注册营养师为20 - 79岁的T2D患者提供服务。使用评估表将患者的行为类型分为四种类型（BT1至BT4）。我们将对BT1和BT2进行独立试验。主要终点是6个月时糖化血红蛋白（HbA1c）值相对于基线值的变化。SILE组和BETSILE组之间的差异将主要按照意向性分析原则进行分析。在对协变量进行调整后，将使用连续变量的一般线性混合效应模型和二分变量的逻辑回归混合效应模型来检验粗效应和多变量调整效应。假设BT1和BT2的效应量分别为0.42和0.33，组内相关系数为0.02，显著性水平为5%（双侧），检验效能为80%，且两组整群数量相等，每组整群中SILE组和BETSILE组各有3名BT1患者以及6名BT2患者，据此计算所需样本量。每组需要16名营养师，总共需要288名患者。
本研究已获得帝京大学医学伦理委员会批准（编号15 - 222）。研究结果将通过同行评审出版物等广泛传播。
UMIN 000023087；预结果。
