- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02579746
Dietary Approach to Stop Hypertension With Sodium (Na) Reduction for Chinese Canadians (DASHNa-CC)
October 19, 2015 updated by: Ping Zou, University of Toronto
The study examined the feasibility of the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadian (DASHNa-CC) intervention and its potential effects on blood pressure, health-related quality of life, and health service utilization.
Half of participants received usual care while the other half received the DASHNa-CC intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hypertension has been identified as the most important risk factor for cardiovascular diseases and accounts for a large proportion of stroke, myocardial infarction and heart failure in the Chinese population.
While unhealthy diet has been identified as a modifiable risk factor for hypertension, there is a lack of culturally sensitive dietary intervention targeting Chinese Canadians.
The 8-week DASHNa-CC intervention incorporated Dietary Approach to Stop Hypertension (DASH) diet, sodium reduction with the food therapy of Traditional Chinese Medicine, and included an intervention manual, two sessions of classroom instruction delivered in Mandarin, and a 20-minute telephone follow-up.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- were at least 45 years old;
- had a systolic blood pressure 140 to 159 mmHg, or a diastolic blood pressure 90 to 99 mmHg, based on pre-intervention baseline assessment;
- were able to understand (listen) and speak in Mandarin, read and write in Chinese; and
- had access to a telephone.
Exclusion Criteria:
- used antihypertensive medications or other medications that raise or lower blood pressure during the previous three months;
- used TCM or professional TCM counselling to decrease blood pressure during the previous three months;
- used insulin or oral hypoglycemic agents during the previous three months;
- had a history of a cardiovascular event (stroke, myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass surgery, or other arteriosclerotic cardiovascular disease related therapeutic procedure) during the previous three months;
- had a history of congestive heart failure;
- had a cancer diagnosis or treatment during the past two years;
- had special dietary requirements;
- were pregnant, breast feeding, or planned for pregnancy prior to the anticipated end of study;
- were a household member of another DASHNa-CC participant; or
- planned to leave the area prior to the anticipated end of study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention
The intervention group received usual care plus the DASHNa-CC intervention.
|
The 8-week DASHNa-CC intervention incorporated Dietary Approach to Stop Hypertension (DASH) diet, sodium reduction with the food therapy of Traditional Chinese Medicine, and included an intervention manual, two sessions of classroom instruction delivered in Mandarin, and a 20-minute telephone follow-up.
education booklet, encouragement of physician visit, use of public health resources if needed
|
|
Active Comparator: control
The control group received usual care.
|
education booklet, encouragement of physician visit, use of public health resources if needed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood pressure
Time Frame: 8 weeks post randomization
|
systolic and diastolic blood pressure
|
8 weeks post randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
health related quality of life
Time Frame: 8 weeks post randomization
|
used SF-36v2
|
8 weeks post randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
October 16, 2015
First Submitted That Met QC Criteria
October 19, 2015
First Posted (Estimate)
October 20, 2015
Study Record Updates
Last Update Posted (Estimate)
October 20, 2015
Last Update Submitted That Met QC Criteria
October 19, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UofT30496
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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