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Lifestyle Management of CKD in Obese Diabetic Patients

肥胖糖尿病患者 CKD 的生活方式管理

基本信息

批准号：
8818276
负责人：
Mary A Sevick
金额：
$ 75.75万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-18 至 2019-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8818276
关键词：
Address Affect Age Analysis of Variance Behavior Behavior Therapy Behavioral Blood Pressure Blood Vessels Body Weight Body Weight decreased Caloric Restriction Calories Chronic Kidney Failure Complex Complication Consumption Counseling Cues Diabetes Mellitus Dialysis procedure Diet Diet Monitoring Dietary Sodium Disease Progression Eating Eating Behavior End stage renal failure Epidemic Epidemiologic Studies Equation Excretory function Fasting Feedback Feeling Food Goals HDL-triglyceride Habits Hand Holidays Hour Hypertension Individual Intake Intervention Kidney Diseases LDL Cholesterol Lipoproteins Life Style Link Lipids Literature Logistics Measurement Measures Mediating Medicare Medication Management Methods Modeling Monitor Non-Insulin-Dependent Diabetes Mellitus Nutrient Obesity Outcome Participant Patients Pharmaceutical Preparations Phosphorus Physical activity Physiologic pulse Play Randomized Randomized Clinical Trials Research Response to stimulus physiology Role Self Efficacy Serum Side Sodium Staging Statistical Models Stimulus Technology Testing Transplantation Treatment Cost United States Weight arm arterial stiffness base behavior change beneficiary diabetic diabetic patient dietary restriction group counseling information processing inorganic phosphate learned behavior older patient preference primary outcome public health relevance social social cognitive theory sodium phosphate treatment as usual urinary weight loss intervention

项目摘要

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.

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。