South Asian Low-sodium Trial

Hypertension Clinical Trial

— SALT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05136911
• Other study ID #: 37070
• Status: Terminated
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: April 29, 2020

Study information

• Verified date: November 2021
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: April 29, 2020
• Est. primary completion date: April 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• SALT-Intervention
Participants in the intervention group will have access to all standard care as provided to the usual care group participants. In addition, participants in the intervention group will receive the SALT-intervention developed by the principal investigator in the form of a SALT-intervention consist of the Salt Intervention manual, five online modules which include a virtual cooking demonstration and five ten-minute weekly telephone calls delivered by the principal investigator.These strategies aim to increase knowledge, enhance self-management abilities and provide social support.

Locations

Country	Name	City	State
Canada	Social Services Network	Markham	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcomes-1	Systolic BP	At baseline and at completion of the study-6 weeks
Other	Exploratory outcomes-2	Diastolic BP	At baseline and at completion of the study-6 weeks
Other	Exploratory outcomes-3	24-hour urinary sodium	At baseline and at completion of the study-6 weeks
Primary	Recruitment	Number of eligible participants agreeing to participate compared to total eligible participants	End of study-6 weeks
Primary	Retention	Number of participants who complete follow-up assessment at 6-weeks.	Through study completion-6 weeks
Primary	Intervention Engagement with the SALT Intervention Manual	Number of participants in the intervention group who read the manual in its entirety	Through study completion, 6-weeks
Primary	Intervention Engagement with five weekly online modules	Number of participants in the intervention group who complete the five weekly online modules	Through study completion, 6-weeks
Primary	Intervention Engagement with five weekly goal-setting worksheets	Number of participants in the intervention group who complete the five goal-setting worksheets	Through study completion, 6-weeks
Primary	Intervention Engagement with five weekly telephone calls	Number of participants in the intervention group who complete the five weekly telephone calls	Through study completion, 6-weeks
Primary	Intervention Acceptability Questionnaire	Intervention Acceptability (Likert scale): Minimum Score: 0 and Maximum Score: 40, Higher score indicate higher acceptability	Through study completion, 6-weeks
Primary	Intervention Acceptability-1	Ease of reading SALT-Intervention Manual	Through study completion, 6-weeks
Primary	Intervention Acceptability-2	Ease of using goal-setting worksheets	Through study completion, 6-weeks
Primary	Intervention Acceptability-3	Ease of using online modules	Through study completion, 6-weeks
Primary	Intervention Acceptability-4	Ease of viewing cooking demonstration	Through study completion, 6-weeks
Primary	Intervention Acceptability-6	Ease of attending weekly telephone calls	Through study completion, 6-weeks
Primary	Intervention Acceptability-7	Encouragement to reduce sodium	Through study completion, 6-weeks
Primary	Intervention Acceptability-8	Satisfaction with time to complete study components	Through study completion, 6-weeks
Primary	Intervention Acceptability	Overall satisfaction with the study	Through study completion, 6-weeks
Secondary	Secondary outcome 1: Knowledge related to dietary sodium	To describe the knowledge related to dietary sodium in South Asian Canadians using KAB survey	At baseline and at 6-weeks
Secondary	Secondary outcome 2: Attitudes related to dietary sodium	To describe attitudes related to dietary sodium in South Asian Canadians using KAB survey	At baseline and at 6-weeks
Secondary	Secondary outcome 3: Behaviours related to dietary sodium	To describe behaviours related to dietary sodium in South Asian Canadians using KAB survey	At baseline and at 6-weeks