A Non-randomised Feasibility Study for a Large-scale Clinical Trial (Phase II) Testing Reduced-sodium Salt for the Prevention of the Rise in Blood Pressure With Age Among Children and Adults (6+ Years) in Nigeria (RAISED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Rate of recruitment
研究概览
简要总结
The study is a small-scale, short-term unblinded feasibility study to explore the acceptability and feasibility of implementing a reduced-sodium iodised salt intervention in Nigeria. This study will be used to inform a large-scale intervention trial comparing the effects of reduced-sodium salt versus regular salt on the rise in blood pressure with age.
详细描述
Reduced-sodium salts are a proven method for reducing sodium intake and lowering blood pressure. No studies to date have tested the effects of sodium reduction on the rise in blood pressure with age during adulthood or the critical periods of childhood and adolescence. The investigators want to explore whether reducing dietary sodium intake using reduced-sodium salt in comparison to regular salt, will attenuate the rise in blood pressure with age. This feasibility study aims to determine the feasibility of implementing a reduced-sodium iodised salt (66% potassium chloride, 34% sodium chloride) intervention in Nigeria. Specifically, the investigators will explore the feasibility of recruiting households with at least one child or adolescent 6-17 years of age and one adult ≥18 years, the acceptability of the reduced-sodium salt intervention, adherence to study procedures and data collection methods, and the effect of the reduced-sodium salt intervention on blood pressure. Secondary outcomes include household eligibility, household composition, willingness to engage in monthly follow-up visits in a longer-term trial, blood pressure, urinary sodium and potassium concentrations, height and weight. This study will be used to inform a large-scale intervention trial comparing the effects of reduced-sodium salt versus regular salt on the rise in blood pressure with age. The study will be conducted in two rural communities in Nigeria and will recruit 30 households (approximately 150 participants). All participants will be provided with the reduced-sodium salt intervention to replace all regular salt used for cooking, seasoning and food preservation over a 2-month period; there will be no control. Follow-up visits will be at 1 month and 2 months after the baseline visit, conducted either at the home or a local community healthcare centre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one household member is a child or adolescent (6-17 years) and at least one household member is an adult (≥18 years)
- •All household members consume greater than half of meals as food prepared in the home (self-report)
- •All household members provide signed informed consent/assent (consent obtained from legal guardians for those <18 years of age; assent also obtained from children/adolescents ≥12 years of age)
排除标准
- •Any household member has serious renal impairment.
- •Any household member uses a potassium-sparing diuretic.
- •Any household member uses a potassium supplement.
- •Any household member has other reason for concern about the use of reduced-sodium salt.
结局指标
主要结局
Rate of recruitment
时间窗: 2 months
Measured as the number of households recruited each month
Adherence to the reduced-sodium salt intervention
时间窗: 2 months
Measured as the self-reported proportion of regular salt replaced with intervention salt at each follow-up visit. The investigators will also estimate the quantity of intervention salt used by the household at each follow-up visit by visually estimating the amount of intervention salt that remains unused.
Acceptability of the reduced-sodium salt intervention
时间窗: 2 months
Measured as the percentage of participants that identify 'good', 'really good' or 'super good' on a brief questionnaire administered at the 2-month follow-up visit
Completion rate of visits
时间窗: 2 months
Measured as the percentage of participants that provide key data points (e.g., blood pressure, safety) at each visit
次要结局
- Weight(2 months)
- Systolic and diastolic blood pressure(2 months)
- Total number and percentage of households eligible to participate in the study(2 months)
- Average number of participants per household and breakdown by age group(2 months)
- Willingness to engage in monthly follow-up visits in a longer-term trial (48-months)(2 months)
- Urinary potassium concentration(2 months)
- Urinary sodium concentration(2 months)