mDASHNa-CC APP to Support a Healthy Diet and Hypertension Control for Chinese Canadian Seniors

Hypertension Clinical Trial

Official title:

Design, Usability Testing, and Feasibility Testing of a Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03988894
• Other study ID #: 02579746
• Status: Not yet recruiting
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Diet, Healthy
• Hypertension

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