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临床试验/NCT05136911
NCT05136911终止不适用

South Asian Low-sodium Trial: A Pilot Randomized Controlled Trial

University of Toronto2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
23
试验地点
2
主要终点
Retention

研究概览

简要总结

The overall goal of this pilot study is to examine the feasibility and acceptability of a culturally-tailored low-sodium dietary intervention is South Asian Canadians with stage one HTN. Specific objectives are to determine the feasibility (recruitment, retention, engagement and acceptability) of this intervention. Secondary outcomes include the effect of low-sodium dietary intervention on knowledge, attitude and self-regulation behaviours. Exploratory outcomes include its effect of systolic, diastolic blood pressure and sodium intake. Information obtained from this pilot trial will inform design of a larger randomized controlled trial in reducing BP in South Asian Canadians.

详细描述

Cardiovascular disease is the leading cause of mortality and morbidity worldwide. Hypertension (HTN) is an important risk factor for cardiovascular disease. According to HTN Canada guidelines, HTN is classified as pre-hypertension (systolic BP of 120-139 mmHg or diastolic BP of 80-89 mmHg), stage one HTN ( systolic BP 140-159 mmHg or diastolic BP 90-99 mmHg) and stage two HTN (greater than or equal to systolic BP of 160 mmHg or greater than or equal to diastolic BP of 100 mmHg) (2). Any increase in blood pressure above optimal confers independent risk of cardiovascular disease, stroke, congestive heart failure, end-stage renal disease, peripheral vascular disease, dementia, atrial fibrillation and retinopathy. South Asian individuals have significantly higher rates of morbidity and mortality from cardiovascular diseases. Hypertension is prevalent in South Asian Canadians with prevalence rate of 17%. Hypertension is a result of various factors, which include excessive alcohol consumption. lack of dietary potassium, physical inactivity, obesity and high dietary sodium intake. High dietary sodium consumption is an important contributor to HTN. and the rapid increase in dietary sodium is contributing to the current epidemic of HTN and cardiovascular disease. Sodium has a positive linear causal relationship to blood pressure based on epidemiological and experimental studies. Sodium intake greater than 2300mg/day has been associated with an increased risk of developing HTN. In addition to HTN, excess sodium intake is associated with higher risk of developing dementia, osteoporosis, stomach cancer, left ventricular hypertrophy and heart failure. The average sodium intake of Canadians is currently estimated at 2760mg/day, which is well above the recommended daily intake of 2300mg/day. South Asians consume significantly higher amounts of sodium with more than 95% of South Asians add salt to their cooking. Sodium intake in South Asians has been reported in different countries as; 3456 mg/day in Pakistan, 3548-3708 mg/day in India, 5863-10,000mg/day in Bangladesh. Although dietary patterns vary considerably in South Asians, addition of salt during food preparation and at the table are common practices across communities. The combination of traditional as well as a western diet results in an increased amount of sodium from conveniently available traditional meals, consumption of bread, pizza, pasta and other processed foods, high sodium spices and addition of salt during cooking.

Interventions aimed at reducing dietary sodium reduces blood pressure as well as cardiovascular morbidity and mortality. Despite the known benefits of sodium reduction interventions in reducing blood pressure in the Caucasian population, there is limited research available to provide evidence that sodium reduction is beneficial in reducing blood pressure in South Asian Canadians with stage one HTN.

The primary purpose of the South Asian Low-sodium Trial (SALT) is to assess feasibility (recruitment, retention, engagement and acceptability) of implementing a six-week low-sodium community-based dietary intervention in South Asian Canadians with stage one HTN. Secondary objectives include assessing knowledge & attitude and self-regulation behaviours. Exploratory objectives are to assess change in systolic BP, diastolic BP and sodium intake.

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)

盲法说明

The principal investigator will be responsible for randomization and the outcome assessor (research assistant) will be blinded to group allocation. The research assistant will collect all outcome data at 6 weeks from the intervention and usual care group.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • South Asian individuals (India, Pakistan, Srilanka, Bangladesh, Nepal and Bhutan) over the age of 18 years
  • Stage one HTN, systolic BP of 140-159 mmHg or diastolic BP of 90-99 mmHg at baseline and not on anti-hypertensive medications
  • Consuming a daily sodium intake of >2000 mg/24 hours as determined at baseline by an online Salt Calculator,
  • Able to read, understand and write English
  • Access to computer with internet capabilities and a telephone

排除标准

  • Use of anti-hypertensive medications
  • Use of herbal or over-the counter medications to control BP
  • Use of insulin or oral hypoglycemic agents
  • Have an active cancer diagnosis or on treatment during the past three months due to interference between diet and cancer treatment
  • Have special dietary requirements and unable to consume a self-selected diet
  • Are pregnant, breastfeeding or anticipate pregnancy prior to the end of the study
  • Individuals who plan to leave the area prior to the anticipated end of study

结局指标

主要结局

Retention

时间窗: Through study completion-6 weeks

Number of participants who complete follow-up assessment at 6-weeks.

Intervention Engagement with the SALT Intervention Manual

时间窗: Through study completion, 6-weeks

Number of participants in the intervention group who read the manual in its entirety

Intervention Engagement with five weekly online modules

时间窗: Through study completion, 6-weeks

Number of participants in the intervention group who complete the five weekly online modules

Intervention Engagement with five weekly goal-setting worksheets

时间窗: Through study completion, 6-weeks

Number of participants in the intervention group who complete the five goal-setting worksheets

Intervention Acceptability-1

时间窗: Through study completion, 6-weeks

Ease of reading SALT-Intervention Manual

Intervention Acceptability-6

时间窗: Through study completion, 6-weeks

Ease of attending weekly telephone calls

Recruitment

时间窗: End of study-6 weeks

Number of eligible participants agreeing to participate compared to total eligible participants

Intervention Acceptability Questionnaire

时间窗: Through study completion, 6-weeks

Intervention Acceptability (Likert scale): Minimum Score: 0 and Maximum Score: 40, Higher score indicate higher acceptability

Intervention Acceptability-2

时间窗: Through study completion, 6-weeks

Ease of using goal-setting worksheets

Intervention Engagement with five weekly telephone calls

时间窗: Through study completion, 6-weeks

Number of participants in the intervention group who complete the five weekly telephone calls

Intervention Acceptability-4

时间窗: Through study completion, 6-weeks

Ease of viewing cooking demonstration

Intervention Acceptability-7

时间窗: Through study completion, 6-weeks

Encouragement to reduce sodium

Intervention Acceptability

时间窗: Through study completion, 6-weeks

Overall satisfaction with the study

Intervention Acceptability-3

时间窗: Through study completion, 6-weeks

Ease of using online modules

Intervention Acceptability-8

时间窗: Through study completion, 6-weeks

Satisfaction with time to complete study components

次要结局

  • Secondary outcome 1: Knowledge related to dietary sodium(At baseline and at 6-weeks)
  • Secondary outcome 2: Attitudes related to dietary sodium(At baseline and at 6-weeks)
  • Secondary outcome 3: Behaviours related to dietary sodium(At baseline and at 6-weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salima Hemani

Principal Investigator

University of Toronto

研究点 (2)

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