Effectiveness of a Community Health Worker-Led Low-Sodium Salt Intervention to Reduce Blood Pressure: A Cluster Randomized Controlled Trial in Rural Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 618
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure at 6 months
研究概览
简要总结
The sodium found in salt is a powerful cause of high blood pressure, and most sodium ingested by humans is from their diet. High blood pressure is known to cause heart attacks and strokes, so various public health programs have attempted to find ways for people to reduce their salt intake to avoid these complications. These programs, however, have proven challenging, as asking people to alter their food preparation practices is often met with resistance. As such, we wish to test the blood pressure-lowering effects of low sodium salt substitute (LSSS), a salt substance in which a third of the compound by weight is composed of potassium (which does not increase blood pressure) rather than sodium. Additionally, the best way of supplying LSSS to people is yet unknown. We thus propose to study the effectiveness of an LSSS product by directly providing it via community health workers in 309 households in rural Bangladesh.
详细描述
The overall objective of this study is to assess the effectiveness of providing access to low-sodium salt substitute (LSSS) (a compound in which a percentage of the sodium chloride (NaCl) is replaced by potassium chloride (KCl) for blood pressure (BP) reduction in a general population of adults (aged 18 years and older) in rural Bangladesh. The intervention will be delivered in the study wing by community health workers to determine if this method is an efficacious approach for blood pressure lowering in this setting.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
intervention), participants cannot be blinded. Investigators not involved in the allocation and direct data collection efforts, however, including the analysts, will be blinded to which household received which intervention. Of note, the community health workers responsible for provisioning the intervention and conducting the baseline survey will be a separate team of field workers from those collecting the endline outcomes assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Our target population is that of adults living in rural Bangladesh, while our study population will be comprised of adults (age ≥18 years old) living in Parbatipur, a rural/semi-rural sub-district in Dinajpur District (Rangpur Division), in the north of the country. Within Parbatipur, BRAC University has assessed 700 households for NCD risk factors as part of a larger Wellcome-trust funded multinational biobank (involving those living in Bangladesh, India, Pakistan, and Sri Lanka) to better understand the patterns and determinants of cardiovascular health in South Asian people in a cross-sectional analysis. All adults living in these surveyed households will be eligible to participate.
排除标准
- •Exclusion criteria include subjects taking potassium-sparing diuretics, already taking potassium supplements, or those who have known kidney disease at baseline.
- •All adults initially screened for intervention will undergo serum creatinine testing, with those with values >106 mMol/L for males and >97 mMol/L for female excluded from the intervention but kept in the intervention group by intention-to-treat principles to avoid breaking of randomization.
- •Although minors will not be involved in the study, to avoid spillover injury to children in the intervention households, all members of intervention households under the age of 18 will also undergo urine dipstick testing. If proteinuria is detected, the household will be excluded from receiving the LSSS intervention (but followed in the intervention arm to avoid breaking randomization).
研究组 & 干预措施
Free LSSS Arm
Participants will receive 6 months of free low-sodium salt by delivery from a community health worker. In addition, the same educational information as provided in Arm 2 (Information Only Arm, below) will be provided.
干预措施: Low-Sodium Salt Substitute (Dietary Supplement)
Free LSSS Arm
Participants will receive 6 months of free low-sodium salt by delivery from a community health worker. In addition, the same educational information as provided in Arm 2 (Information Only Arm, below) will be provided.
干预措施: Information/Education (Behavioral)
Information Only Arm
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)
干预措施: Information/Education (Behavioral)
No Intervention
Participants will not receive any intervention of any sort.
结局指标
主要结局
Change in Systolic Blood Pressure at 6 months
时间窗: 6 months
Systolic blood pressure will be treated as a continuous variable expressed in millimeters of mercury (mmHg). This measurement will be made by trained fieldworkers using Omron Series 3 automatic portable blood pressure cuffs (Omron Healthcare, Kyoto, Japan) while trial subjects are in the seated position in the left arm after 15 minutes rest. Three measurements will be taken at least 5 minutes apart to ensure accurate capture, with the mean of the second and third measurements used in the final data analysis. These measurements will be taken at both baseline (prior to the initiation of the intervention) and at the endline survey at the conclusion of the study.
Change in Diastolic Blood Pressure at 6 months
时间窗: 6 months
Diastolic blood pressure will be treated as a continuous variable expressed in millimeters of mercury (mmHg). This measurement will be made by trained fieldworkers using Omron Series 3 automatic portable blood pressure cuffs (Omron Healthcare, Kyoto, Japan) while trial subjects are in the seated position in the left arm after 15 minutes rest. Three measurements will be taken at least 5 minutes apart to ensure accurate capture, with the mean of the second and third measurements used in the final data analysis. These measurements will be taken at both baseline (prior to the initiation of the intervention) and at the endline survey at the conclusion of the study.
次要结局
- Number of Participants with Hypertension(6 months)
- Number of Participants AchievingHypertension Control(6 months)
研究者
Pascal Geldsetzer
Assistant Professor
Stanford University