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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03988894
Other study ID # 02579746
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date January 10, 2020
Est. completion date June 30, 2021

Study information

Verified date June 2019
Source University of Toronto
Contact Ping Zou
Phone 14166427003
Email pingz@nipissingu.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this proposed study is to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadian (DASHNa-CC), a classroom-based antihypertensive dietary educational intervention, to an innovative smartphone app (mDASHNa-CC) to enable Chinese Canadian seniors' access to this antihypertensive dietary intervention anytime, regardless of where they are.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 30, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- have a systolic blood pressure higher than 140 mmHg, or a diastolic blood pressure higher than 90mmHg, or are on antihypertensive medications, based on pre-intervention baseline assessment

- are able to understand (listen) and speak in Mandarin or Cantonese, read and write in Chinese

- have access to a smartphone

Exclusion Criteria:

- have special dietary requirements

- are a household member of another mDASHNa-CC participant

- plan to leave the area prior to the anticipated end of study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
mDASHNa App
The functions of the app will include: (a) antihypertensive dietary education; (b) dietary self-assessment; (c) automatic feedback according to dietary self-assessment; (d) blood pressure monitoring; and (e) automatic feedback according to blood pressure data.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Outcome

Type Measure Description Time frame Safety issue
Primary change of systolic Blood Pressure from baseline to eight weeks after randomization Systolic blood pressures will be measured by the home blood pressure monitor, Omron BP785, whose validity and reliability have been tested eight weeks after randomization
Primary change of diastolic Blood Pressure from baseline to eight weeks after randomization diastolic blood pressures will be measured by the home blood pressure monitor, Omron BP785, whose validity and reliability have been tested eight weeks after randomization
Primary change of body weight from baseline to eight weeks after randomization Weight will be measured by an electronic body weight scale (Rubbermaid® Digital Utility Scale, Model number H-479, Capacity/Accuracy 400 lbs * 0.5 lb) eight weeks after randomization
Primary change of waist circumference from baseline to eight weeks after randomization Waist circumference will be measured by measurement tape following proper technique eight weeks after randomization
Primary change of Health-related Quality of Life from baseline to eight weeks after randomization Health-related quality of life will be measured by Medical Outcomes Study 36-Item Short Form version two. The SF-36v2 required ten minutes to complete and consisted of 36 items and eight domains, which could be grouped into physical and mental component summaries. All domains were scored on a scale ranging from 0 to 100, wherein 0 represented the worst overall health status and 100 the best health status. eight weeks after randomization
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