Clinical trial NCT05136911: South Asian Low-sodium Trial
Official title: South Asian Low-sodium Trial: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic two-arm parallel 6-week randomized controlled Trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Recruitment
timeFrame: End of study-6 weeks
measure: Retention
timeFrame: Through study completion-6 weeks
measure: Intervention Engagement with the SALT Intervention Manual
timeFrame: Through study completion, 6-weeks
measure: Intervention Engagement with five weekly online modules
timeFrame: Through study completion, 6-weeks
measure: Intervention Engagement with five weekly goal-setting worksheets
timeFrame: Through study completion, 6-weeks
measure: Intervention Engagement with five weekly telephone calls
timeFrame: Through study completion, 6-weeks
measure: Intervention Acceptability Questionnaire
timeFrame: Through study completion, 6-weeks
measure: Intervention Acceptability-1
timeFrame: Through study completion, 6-weeks
measure: Intervention Acceptability-2
timeFrame: Through study completion, 6-weeks
measure: Intervention Acceptability-3
timeFrame: Through study completion, 6-weeks
measure: Intervention Acceptability-4
timeFrame: Through study completion, 6-weeks
measure: Intervention Acceptability-6
timeFrame: Through study completion, 6-weeks
measure: Intervention Acceptability-7
timeFrame: Through study completion, 6-weeks
measure: Intervention Acceptability-8
timeFrame: Through study completion, 6-weeks
measure: Intervention Acceptability
timeFrame: Through study completion, 6-weeks
Secondary outcomes:
measure: Secondary outcome 1: Knowledge related to dietary sodium
timeFrame: At baseline and at 6-weeks
measure: Secondary outcome 2: Attitudes related to dietary sodium
timeFrame: At baseline and at 6-weeks
measure: Secondary outcome 3: Behaviours related to dietary sodium
timeFrame: At baseline and at 6-weeks
Other outcomes:
measure: Exploratory outcomes-1
timeFrame: At baseline and at completion of the study-6 weeks
measure: Exploratory outcomes-2
timeFrame: At baseline and at completion of the study-6 weeks
measure: Exploratory outcomes-3
timeFrame: At baseline and at completion of the study-6 weeks
Locations:
city: Markham
country: Canada
facility: Social Services Network
state: Ontario
Study officials:
affiliation: University of Toronto, Lawrence S. Bloomberg Faculty of Nursing
name: Salima Hemani, RN, PhD C.
role: PRINCIPAL_INVESTIGATOR
References: