The Effectiveness of an Educational Intervention for Sodium Restriction in Patients With Hypertension: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes from baseline, after 8 weeks and 6 months in Dietary Sodium Restriction Questionnaire (DSRQ) score
研究概览
简要总结
This parallel, randomized clinical trial will include 120 participants. They will be allocated to a sodium restriction educational intervention or usual care groups. The educational intervention will be planned based on the DSRQ application and sessions will be conducted once a month for the period of six months. Both spot urine collection to estimate sodium intake and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. Blood sample and 24-hour ambulatory blood pressure monitoring (ABPM) will be conducted at the beginning and at the end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-hour food recall will be collected during follow-up.
详细描述
This parallel, randomized clinical trial will include 120 participants. They will be allocated to a sodium restriction educational intervention or usual care groups. The educational intervention will be planned based on the DSRQ application and sessions will be conducted once a month for the period of six months. Both spot urine collection to estimate sodium intake and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. Blood sample and 24-hour ambulatory blood pressure monitoring (ABPM) will be conducted at the beginning and at the end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-hour 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 non-adherence 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, better hypertension control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female and male individuals, ageing from 40 to 80 years old, in treatment and monitored at the hypertensive outpatient department of HCPA. Participants must not have been monitored by a nutritionist or followed a nutritional orientation for over than six months
排除标准
- •pregnancy or lactating; gastrointestinal tract disease; inflammatory disease; chemotherapy treatment; diabetes diagnosis; incapacity to follow an interview and/or to participate in the intervention program without the need of a third party involvement
结局指标
主要结局
Changes from baseline, after 8 weeks and 6 months in Dietary Sodium Restriction Questionnaire (DSRQ) score
时间窗: 6 months
次要结局
- Changes from baseline, after 8 weeks and 6 months in urinary sodium values(6 months)
- Questionnaire sensitivity and specificity by the comparison of Dietary Sodium Restriction Questionnaire (DSRQ) scores to urinary sodium values(6 months)
- Changes from baseline, after 8 weeks and 6 months in blood pressure mean assessed by ABPM(6 months)