Lifestyle Management of CKD in Obese Diabetic Patients

 描述(申请人提供)：这项随机临床试验的目的是，与常规护理相比，评估3种不同技术支持的方法的有效性，这些方法涉及300名糖尿病合并慢性肾脏疾病患者的减肥、体力活动、饮食钠限制和无机磷饮食限制。参与者将被随机分成4组中的一组，即日常护理(UC)、基于社会认知理论的团体咨询(SCT)、带有量身定制的反馈和建议的移动自我监控(监控)或SCT加监控条件的组合(组合)。我们将主要从体重减轻、尿钠排泄和血磷方面对干预药物进行评估。我们将探索对体力活动、血压、空腹血脂、药物需求和脉搏波速度的影响。测量将在基线、6个月和12个月进行。交互作用效应将使用双因素方差分析进行检验。基线、6个月和12个月结果的统计建模将基于Logistic广义线性混合模型(对于二元结果)、线性混合模型(对于连续结果)和随机效应多项模型(对于超过两个水平的结果，例如药物管理的变化)。自我效能感对初级结果的中介作用将使用结构方程模型进行评估。

 DESCRIPTION (provided by applicant): The purpose of this randomized clinical trial is to evaluate, when compared to usual care, the efficacy of 3 different technology-supported approaches to engaging 300 individuals with diabetes and concurrent chronic kidney disease in weight loss, physical activity, dietary sodium restriction, and dietary restriction of inorganic phosphates. Participants will be randomized to 1 of 4 groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile self-monitoring with tailored feedback and advice (MONITORING), or a combination of SCT plus MONITORING conditions (COMBINED). We will evaluate the intervention arms primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus. We will explore the impact on physical activity, blood pressure, fasting lipids, medication requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months. Interaction effects will be examined using a 2-way ANOVA. Statistical modeling of baseline, 6 mos and 12 mos outcomes will be based on logistic generalized linear mixed models (for binary outcomes) linear mixed models (for continuous outcomes), and random effects multinomial models (for outcomes with more than 2 levels, such as changes in medication management). The mediating effect of self-efficacy on the primary outcomes will be evaluated using structural equation models.