Rodrigues Marcela Perdomo, Dos Santos Luciana Kaercher John, Fuchs Flavio Danni, Fuchs Sandra Costa, Moreira Leila Beltrami
Postgraduate Studies Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
Division of Cardiology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Trials. 2017 Jul 21;18(1):347. doi: 10.1186/s13063-017-2091-4.
The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit changing should be of a motivational nature in order to develop the ability of overcoming obstacles regarding sodium-restriction behavior. The present study aims to describe the protocol and randomization of a clinical trial design in order to evaluate the effectiveness of an educational intervention based on Dietary Sodium Restriction Questionnaire (DSRQ) scores. The effectiveness measures are the DSRQ score variation and reduction in urinary sodium values from baseline to after 2 and 6 months.
METHODS/DESIGN: This parallel, randomized clinical trial will include 120 participants, recruited and randomized as follows: 60 of them to be allocated to a sodium-restriction educational intervention group whose results are based on the DSRQ application; and the other 60 allocated to a control group with usual care. Educational orientation and usual care sessions will be conducted once a month for a period of 6 months. Both spot urine collection - estimating sodium intake - and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. There will also be blood collection and 24-h ambulatory blood pressure monitoring (ABPM) at the beginning and end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-h food recall will be collected during follow-up.
The study "The effectiveness of an educational intervention to sodium restriction in patients with hypertension" is based on the results of the DSRQ application, whose objective is to evaluate aspects related to nonadherence to the recommendation of a low-sodium diet, identifying adherence barriers and facilitators, contributing to the planning of interventions for improving the adoption of a low-sodium diet and, consequently, hypertension control.
ClinicalTrials.gov, Identifier: NCT02848690 . Registered retrospectively on 27 July 2016.
多项研究已证实非药物干预在降低血压方面的有效性。然而，由于对低钠饮食的依从性较差，关于习惯改变的干预措施应具有激励性质，以培养克服钠限制行为障碍的能力。本研究旨在描述一项临床试验设计的方案和随机化过程，以评估基于饮食钠限制问卷（DSRQ）评分的教育干预的有效性。有效性指标为DSRQ评分变化以及从基线到2个月和6个月后尿钠值的降低。
方法/设计：这项平行随机临床试验将纳入120名参与者，招募和随机分组如下：其中60名被分配到钠限制教育干预组，其结果基于DSRQ应用；另外60名被分配到接受常规护理的对照组。教育指导和常规护理课程将每月进行一次，为期6个月。在基线、第8周和随访结束时均会进行即时尿样采集（估计钠摄入量）和DSRQ评估。在随访开始和结束时还将进行血液采集和24小时动态血压监测（ABPM）。在随访期间将收集人体测量数据、血压测量值和24小时食物回顾信息。
“高血压患者钠限制教育干预的有效性”研究基于DSRQ应用的结果，其目的是评估与不遵守低钠饮食建议相关的方面，识别依从性障碍和促进因素，有助于规划改善低钠饮食采用情况从而控制高血压的干预措施。
ClinicalTrials.gov，标识符：NCT02848690。于2016年7月27日进行回顾性注册。
