Diet, Exercise and Cardiovascular Health - Effect of Salt Substitute and Stepwise Salt Supply Control in Reducing Blood Pressure in the Elderly in Nursing Homes in China: a Factorial Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,612
- 试验地点
- 1
- 主要终点
- The change in systolic blood pressure from baseline to follow-up
研究概览
简要总结
The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction Strategies for the Elderly in Nursing Homes in China) is to evaluate the effects, safety and cost-effectiveness of salt substitution (SS) and stepwise salt supply control (SSSC) in reducing blood pressure in Chinese elderly in nursing homes. The study will recruit over 960 old people from 48 nursing homes in northern China. The 48 nursing homes will be randomised into the following 4 groups.
- salt substitute (SS) and stepwise salt supply control (SSSC);
- SS only;
- SSSC only; and
- no SS and no SSSC (control).
The intervention will last over 2 years. The randomization will be conducted centrally after the baseline survey completed. Primary outcome will be the change in systolic blood pressure. The secondary outcomes include: the changes in diastolic blood pressure, 24hr urinary sodium, potassium and microalbumin, and incidence of hyperkalemia, hypokalemia, hyponatremia, cardiovascular events, and all causes death, and incremental cost-effectiveness ratio.
详细描述
The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction Strategies for the Elderly in Nursing Homes in China) is a study in the DECIDE project, which includes five studies. The others are DECIDE - Diet, DECIDE - Exercise, DECIDE - Obesity in Children, and DECIDE - Smart Living. The DECIDE - Salt in Elderly study is to evaluate the effects, safety and cost-effectiveness of salt substitution (SS) and kitchen-based stepwise salt supply control (SSSC) in reducing blood pressure in Chinese elderly in nursing homes. Specifically, the study aims include:
- to test if a stepwise salt supply control strategy could significantly reduce systolic blood pressure among elderly living in nursing homes;
- to test if replacing regular salt with the market available salt substitute could significantly reduce systolic blood pressure among elderly living in nursing homes; and
- to test if the joint effect of the two strategies is larger than that from one of each.
The corresponding null hypotheses that will be tested are:
- the mean change from the baseline in systolic blood pressure of elderly residents in nursing homes that are supplied with SS is equal to the mean change from the baseline in systolic blood pressure of elderly residents in nursing homes that are supplied with regular salt;
- the mean change from the baseline in systolic blood pressure of elderly residents in nursing homes that apply SSSC is equal to the mean change from the baseline in systolic blood pressure of elderly residents in nursing homes that do not apply SSSC;
- There is no interaction between the two interventions above.
The study will recruit over 960 old people from 48 nursing homes in northern China, where the mean salt intake is generally higher than 12 g/day. A 2x2 factorial cluster-randomized trial will be used to test two independent salt reduction strategies: 1) using salt substitute to replace the regular salt in the kitchen of nursing homes; and 2) training the nursing manager to control/reduce, step by step, the amount of salt supplied to the kitchen of nursing homes. The 48 nursing homes will be randomized to the following 4 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility of nursing homes:
- •To be eligible, the nursing home must has not participated in any salt reduction or other intervention trials, has at least 20 residents and has agreed to participate in the study.
- •Eligibility of individual elderly:
- •Inclusion Criteria:
- •Living in the nursing home permanently or expectedly for the coming two years
- •Age less than 55 years.
- •Life expectancy over six months.
- •Provide written informed content.
排除标准
- •Clinically confirmed hyperkalemia
结局指标
主要结局
The change in systolic blood pressure from baseline to follow-up
时间窗: baseline、6 month、12 month、18 month and 24-month follow-up
mmHg
次要结局
- The change in 24-hour urinary sodium and potassium(baseline and 24-month follow-up)
- ICER(throughout 24 months of follow-up)
- The incidence of renal dysfunction(throughout 24 months of follow-up)
- The change in 24-hour urinary microalbumin(baseline and 24-month follow-up)
- The change in diastolic blood pressure from baseline to follow-up(baseline、6 month、12 month、18 month and 24-month follow-up)
- The incidence of hypokalemia(throughout 24 months of follow-up)
- Cardiovascular events(throughout 24 months of follow-up)
- Death(throughout 24 months of follow-up)
- The incidence of hyponatremia(throughout 24 months of follow-up)
- The incidence of hyperkalemia(throughout 24 months of follow-up)
研究者
Yangfeng Wu
Prof of Epidemiology and Sciences in Clincial Research
Peking University