社区卫生工作者主导的低盐干预降低孟加拉国农村地区血压的效果：一项群组随机对照试验方案。

Effectiveness of a community health worker-led low-sodium salt intervention to reduce blood pressure in rural Bangladesh: protocol for a cluster randomized controlled trial.

机构信息

Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, USA.

Center for Innovation in Global Health, Stanford University, Stanford, USA.

出版信息

Trials. 2023 Jul 27;24(1):480. doi: 10.1186/s13063-023-07518-3.

DOI:10.1186/s13063-023-07518-3

PMID:37501102

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10375753/

Abstract

BACKGROUND

High blood pressure is a major public health problem in low- and middle-income countries. Low-sodium salt substitute (LSSS) is a promising population-level blood pressure-lowering intervention requiring minimal behavioral change. The optimal method of delivering LSSS to individuals, however, is currently unknown. Community health workers (CHWs) have successfully been used to implement health interventions in Bangladesh and may provide a venue for the dissemination of LSSS.

METHODS

We aim to conduct a cluster-randomized controlled trial involving 309 households in rural Bangladesh previously identified and characterized by the BRAC James P Grant School of Public Health, BRAC University (BRAC JPGSPH). These households will be randomly assigned to three arms: (1) control, i.e., no intervention; (2) information only, i.e., community health workers will provide basic information on high blood pressure, the health consequences of excessive salt consumption, and feedback to the participant on the likely quantity of salt s/he consumes (estimated using a questionnaire); (3) free LSSS arm: the same information as in arm 2 will be provided, but participants will receive 6 months of free low-sodium salt along with education on the benefits of LSSS. One male and one female adult (age ≥ 18 years) in each household will be invited to participate, the exclusion criteria being households with members known to have high serum potassium levels, are taking medications known to elevate potassium levels (e.g., ACE inhibitors, ARBs, potassium-sparing diuretics), are already taking potassium supplements, or those who have known kidney disease or abnormal serum creatinine at baseline. The primary endpoint will be blood pressure at 6 months post-intervention.

DISCUSSION

Recent large clinical trials of LSSS in China and India have shown not only blood pressure improvements, but also stroke, major cardiac event, and all-cause mortality reductions. Nevertheless, how to best translate this intervention to population-level effectiveness remains unclear. Our study would test whether a community health worker-based program could be effectively used to disseminate LSSS and achieve measurable blood pressure benefits.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05425030. Registered on June 21, 2022.

摘要

背景

高血压是中低收入国家的一个主要公共卫生问题。低钠盐替代物（LSSS）是一种有前途的降低人群血压的干预措施，只需要最小的行为改变。然而，向个人提供 LSSS 的最佳方法目前尚不清楚。社区卫生工作者（CHWs）已成功用于在孟加拉国实施卫生干预措施，并且可能为 LSSS 的传播提供一个场所。

方法

我们旨在开展一项涉及孟加拉国农村地区 309 户家庭的整群随机对照试验，这些家庭是由 BRAC 詹姆斯·格兰特公共卫生学院（BRAC JPGSPH）BRAC 大学先前确定和描述的。这些家庭将被随机分配到三个组：（1）对照组，即无干预；（2）仅信息组，即社区卫生工作者将提供高血压、过量盐摄入的健康后果以及参与者可能摄入的盐量的反馈（使用问卷估计）的基本信息；（3）免费 LSSS 组：将提供与第 2 组相同的信息，但参与者将获得 6 个月的免费低钠盐，并接受 LSSS 益处的教育。每个家庭将邀请一名男性和一名女性成年人（年龄≥18 岁）参加，排除标准为已知血清钾水平高、正在服用已知会升高钾水平的药物（如 ACE 抑制剂、ARB、保钾利尿剂）、正在服用钾补充剂或在基线时有已知肾脏疾病或血清肌酐异常的家庭成员。主要终点是干预后 6 个月的血压。