South Asian Low-sodium Trial

NCT05136911 | Terminated

• 1 other identifier: 37070
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (15)

• Recruitment

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

  End of study-6 weeks

• Retention

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

  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

  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

  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

  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

  Through study completion, 6-weeks

• Intervention Acceptability Questionnaire

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

  Through study completion, 6-weeks

• Intervention Acceptability-1

  Ease of reading SALT-Intervention Manual

  Through study completion, 6-weeks

• Intervention Acceptability-2

  Ease of using goal-setting worksheets

  Through study completion, 6-weeks

• Intervention Acceptability-3

  Ease of using online modules

  Through study completion, 6-weeks

• Intervention Acceptability-4

  Ease of viewing cooking demonstration

  Through study completion, 6-weeks

• Intervention Acceptability-6

  Ease of attending weekly telephone calls

  Through study completion, 6-weeks

• Intervention Acceptability-7

  Encouragement to reduce sodium

  Through study completion, 6-weeks

• Intervention Acceptability-8

  Satisfaction with time to complete study components

  Through study completion, 6-weeks

• Intervention Acceptability

  Overall satisfaction with the study

  Through study completion, 6-weeks

Secondary Outcomes (3)

• 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

Other Outcomes (3)

• Exploratory outcomes-1

  At baseline and at completion of the study-6 weeks

• Exploratory outcomes-2

  At baseline and at completion of the study-6 weeks

• Exploratory outcomes-3

  At baseline and at completion of the study-6 weeks

Study Arms (2)

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.

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.

Interventions

SALT-Intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Social Services Network

Markham, Ontario, L3P 2T4, Canada

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Salima Hemani, RN, PhD C.

  University of Toronto, Lawrence S. Bloomberg Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A pragmatic two-arm parallel 6-week randomized controlled Trial

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 30, 2021
• Study Start: August 27, 2019
• Primary Completion: April 29, 2020
• Study Completion: April 29, 2020
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)