Lifestyle Management of CKD in Obese Diabetic Patients

 描述（由申请人提供）：本随机临床试验的目的是评价与常规治疗相比，3种不同技术支持方法对300名糖尿病合并慢性肾脏疾病患者在减肥、体力活动、饮食钠限制和无机磷酸盐饮食限制方面的疗效。受试者将被随机分配至4组中的1组：心理护理（UC）、基于社会认知理论的团体咨询（SCT）、移动的自我监测与定制反馈和建议（MONITORING）或SCT + MONITORING条件的组合（COMBINED）。我们将主要从体重减轻、尿钠排泄和血磷方面对干预组进行评价。我们将探讨对体力活动、血压、空腹血脂、药物需求和脉搏波速度的影响。将在基线、6个月和12个月时进行测量。将使用双因素ANOVA检查相互作用效应。基线、6个月和12个月结局的统计建模将基于logistic广义线性混合模型（对于二元结局）、线性混合模型（对于连续结局）和随机效应多项模型（对于2个以上水平的结局，如药物管理的变化）。将使用结构方程模型评估自我效能对主要结局的中介作用。

 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.