HypertensionSALTNCT05136911
South Asian Low-sodium Trial
A study testing SALT-Intervention in people with Hypertension and Cardiovascular Diseases, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Diseases
- What is being tested?
- SALT-Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 27 Aug 2019to 29 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: South Asian Low-sodium Trial: A Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Hypertension, Cardiovascular Diseases
- Being tested
- SALT-Intervention
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SALT-InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive the standard care in the form of HTN Canada Booklet, advice to see their health care provider, urgent care or walk-in clinic and the Salt Intervention (Salt Intervention Manual, five weekly online modules and five weekly telephone calls. Receives: Behavioral: SALT-Intervention |
| Usual Care Group | No intervention | All participants in the usual care group will receive the standard care in the form of HTN Canada Booklet, advice to see their health care provider, urgent care of walk-in clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of eligible participants agreeing to participate compared to total eligible participants
Measured: End of study-6 weeks
Retention
Number of participants who complete follow-up assessment at 6-weeks.
Measured: Through study completion-6 weeks
Intervention Engagement with the SALT Intervention Manual
Number of participants in the intervention group who read the manual in its entirety
Measured: Through study completion, 6-weeks
Intervention Engagement with five weekly online modules
Number of participants in the intervention group who complete the five weekly online modules
Measured: Through study completion, 6-weeks
Intervention Engagement with five weekly goal-setting worksheets
Number of participants in the intervention group who complete the five goal-setting worksheets
Measured: Through study completion, 6-weeks
Intervention Engagement with five weekly telephone calls
Number of participants in the intervention group who complete the five weekly telephone calls
Measured: Through study completion, 6-weeks
Intervention Acceptability Questionnaire
Intervention Acceptability (Likert scale): Minimum Score: 0 and Maximum Score: 40, Higher score indicate higher acceptability
Measured: Through study completion, 6-weeks
Intervention Acceptability-1
Ease of reading SALT-Intervention Manual
Measured: Through study completion, 6-weeks
Intervention Acceptability-2
Ease of using goal-setting worksheets
Measured: Through study completion, 6-weeks
Intervention Acceptability-3
Ease of using online modules
Measured: Through study completion, 6-weeks
Intervention Acceptability-4
Ease of viewing cooking demonstration
Measured: Through study completion, 6-weeks
Intervention Acceptability-6
Ease of attending weekly telephone calls
Measured: Through study completion, 6-weeks
Intervention Acceptability-7
Encouragement to reduce sodium
Measured: Through study completion, 6-weeks
Intervention Acceptability-8
Satisfaction with time to complete study components
Measured: Through study completion, 6-weeks
Intervention Acceptability
Overall satisfaction with the study
Measured: Through study completion, 6-weeks
Secondary outcomes (3)
Secondary outcome 1: Knowledge related to dietary sodium
To describe the knowledge related to dietary sodium in South Asian Canadians using KAB survey
Measured: At baseline and at 6-weeks
Secondary outcome 2: Attitudes related to dietary sodium
To describe attitudes related to dietary sodium in South Asian Canadians using KAB survey
Measured: At baseline and at 6-weeks
Secondary outcome 3: Behaviours related to dietary sodium
To describe behaviours related to dietary sodium in South Asian Canadians using KAB survey
Measured: At baseline and at 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start27 Aug 2019
- Primary completion29 Apr 2020
- Study completion29 Apr 2020
Why it stopped: The recruitment was stopped due to province-wide lockdown secondary to COVID-19. Blood pressure screenings were conducted in community centres and due to province wide lockdown, further screenings could not be continued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic two-arm parallel 6-week randomized controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salima Hemani, University of Toronto
- Investigators
- Salima Hemani, RN, PhD C., Principal investigator, University of Toronto, Lawrence S. Bloomberg Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136911
- Sponsor's protocol ID
- 37070
- Acronym
- SALT
- Status last verified
- Nov 2021
- First submitted
- 15 Oct 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be completely confidential and will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South Asian Low-sodium Trial: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05136911
- Acronym / sponsor ID
- SALT / 37070
- Conditions
- Hypertension, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment was stopped due to province-wide lockdown secondary to COVID-19. Blood pressure screenings were conducted in community centres and due to province wide lockdown, further screenings could not be continued.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 29 Apr 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A pragmatic two-arm parallel 6-week randomized controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: SALT-InterventionThe intervention group will receive the standard care in the form of HTN Canada Booklet, advice to see their health care provider, urgent care or walk-in clinic and the Salt Intervention (Salt Intervention Manual, five weekly online modules and five weekly telephone calls. |
| Usual Care Group | No intervention | –All participants in the usual care group will receive the standard care in the form of HTN Canada Booklet, advice to see their health care provider, urgent care of walk-in clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SALT-InterventionParticipants 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. | Behavioural | Intervention Group |
Primary outcome
Recruitment
Time frame: End of study-6 weeks
Number of eligible participants agreeing to participate compared to total eligible participants
Retention
Time frame: Through study completion-6 weeks
Number of participants who complete follow-up assessment at 6-weeks.
Intervention Engagement with the SALT Intervention Manual
Time frame: 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
Time frame: 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
Time frame: Through study completion, 6-weeks
Number of participants in the intervention group who complete the five goal-setting worksheets
Intervention Engagement with five weekly telephone calls
Time frame: Through study completion, 6-weeks
Number of participants in the intervention group who complete the five weekly telephone calls
Intervention Acceptability Questionnaire
Time frame: Through study completion, 6-weeks
Intervention Acceptability (Likert scale): Minimum Score: 0 and Maximum Score: 40, Higher score indicate higher acceptability
Intervention Acceptability-1
Time frame: Through study completion, 6-weeks
Ease of reading SALT-Intervention Manual
Intervention Acceptability-2
Time frame: Through study completion, 6-weeks
Ease of using goal-setting worksheets
Intervention Acceptability-3
Time frame: Through study completion, 6-weeks
Ease of using online modules
Intervention Acceptability-4
Time frame: Through study completion, 6-weeks
Ease of viewing cooking demonstration
Intervention Acceptability-6
Time frame: Through study completion, 6-weeks
Ease of attending weekly telephone calls
Intervention Acceptability-7
Time frame: Through study completion, 6-weeks
Encouragement to reduce sodium
Intervention Acceptability-8
Time frame: Through study completion, 6-weeks
Satisfaction with time to complete study components
Intervention Acceptability
Time frame: Through study completion, 6-weeks
Overall satisfaction with the study
3 secondary outcomes
Secondary outcome 1: Knowledge related to dietary sodium
Time frame: At baseline and at 6-weeks
Secondary outcome 2: Attitudes related to dietary sodium
Time frame: At baseline and at 6-weeks
Secondary outcome 3: Behaviours related to dietary sodium
Time frame: At baseline and at 6-weeks
Results and safety
The study was stopped early (reason given: The recruitment was stopped due to province-wide lockdown secondary to COVID-19. Blood pressure screenings were conducted in community centres and due to province wide lockdown, further screenings could not be continued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No. All data will be completely confidential and will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salima Hemani, RN, PhD C. principal investigator
University of Toronto, Lawrence S. Bloomberg Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SALT-Intervention in people with Hypertension and Cardiovascular Diseases, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The recruitment was stopped due to province-wide lockdown secondary to COVID-19. Blood pressure screenings were conducted in community centres and due to province wide lockdown, further screenings could not be continued.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: End of study-6 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.