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

NCT03988894 | Unknown Early Phase 1 DMC

• 1 other identifier: 02579746
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertension; Diet, Healthy

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Control: Usual Care

NO INTERVENTION

All participants will (a) receive a general hypertension health education booklet from the Heart and Stroke Foundation of Ontario;(b) be encouraged to see their family physicians or primary health care providers regarding their blood pressure status; those who do not have a primary health care provider will be referred to a walk-in clinic or a community health centre; and (c) have access to family physicians, tele-health, emergency care, hospital and other health care facilities in the Greater Toronto Area as required.

Intervention: mDASHNa-CC app use

ACTIVE COMPARATOR

In addition to usual care, those participants randomized to the intervention group will be offered use of the app.Then, they will load the app in their smartphones and be requested to review educational contents, conduct dietary self-assessment, and monitor blood pressure for 8 weeks.By the end of eight weeks post randomization, seniors will be prompted by phone using an audible alert to complete the app Evaluation Questionnaire on the smartphone, which ascertains likes and dislikes with the app.

Device: mDASHNa App

Interventions

mDASHNa App DEVICE

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.

Intervention: mDASHNa-CC app use

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Related Publications (1)

• Zou P, Stinson J, Parry M, Dennis CL, Yang Y, Lu Z. A Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors: Protocol for Design, Usability and Feasibility Testing. JMIR Res Protoc. 2020 Apr 2;9(4):e15545. doi: 10.2196/15545.

  PMID: 32238343 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ping Zou

CONTACT

14166427003; pingz@nipissingu.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A pilot two-group (1:1) randomized controlled trial with a sample size of 60 (block of 20) in a Chinese Canadian community in the Greater Toronto Area, Ontario, Canada.

Study Record Dates

• First Submitted: June 8, 2019
• First Posted: June 18, 2019
• Study Start: January 10, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 30, 2021
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share