Prepared Meals to Prime and Perpetuate Reduced Dietary Sodium Intake in Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Interdialytic Weight Gain throughout Length of Study
研究概览
简要总结
This is a randomized clinical trial in which maintenance hemodialysis patients will be provided with salt restricted 'dialysis friendly' meals and compared to a control arm receiving usual care.
详细描述
Patients randomized to the intervention arm will receive 2 months of meals plus dietary counseling. Counseling will continue for an additional 3 months while the control arm will have 5 months of usual care followed by 2 months of meal provision. Effects on interdialytic weight gain, achievement of target dry weight, intradialytic hypotension episodes, blood pressure, and a volume assessment using lung U/S to assess lung water will be measured. Salt sensitivity will be tested throughout the study. Self reported questionnaires about the burden of adhering to the low salt diet and the level of adherence with it will be completed at baseline and throughout the study. The investigator hypothesizes that the prepared meals with prime patients behavior and may alter salt taste perception and that these effects will be sustained after the prepared meals have stopped.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
BP, weight, IDH (as defined by an intra-or post dialysis BP <90 mmHg) will be recorded per usual clinical care by the dialysis unit staff.
Patients will be blinded to the salinity of the salt solutions used to test taste perception and preference.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated with outpatient hemodialysis for >60 days
- •Mean IDWG over the past 30 days >2 kg
- •Speaks and understands English or Chinese
- •Patient has a freezer at home with space to store at least 7 prepared meals
- •Cognitively intact (able to provide informed consent and answer questionnaires)
排除标准
- 未提供
研究组 & 干预措施
Intervention
The experimental arm receives 2 months of sodium restricted prepared meals plus dietary counseling followed by 3 months of counseling alone.
干预措施: Sodium Restricted Meals (Other)
Control
The control arm receives 5 months of usual care followed by 2 months of receipt of sodium restricted prepared meals.
干预措施: Control (Other)
结局指标
主要结局
Change in Interdialytic Weight Gain throughout Length of Study
时间窗: Every two weeks starting through 5months (intervention arm)/ 7 months (control arm)
A standard measurement taken for HD patients at each dialysis session to see weight gained between sessions
次要结局
- Rate of Intradialytic Hypotension Episodes throughout Length of Study(Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm))