NCT02579746

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

October 16, 2015

Last Update Submit

October 19, 2015

Conditions

Keywords

hypertensionimmigrantdietary interventionlifestyle modification

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    systolic and diastolic blood pressure

    8 weeks post randomization

Secondary Outcomes (1)

  • health related quality of life

    8 weeks post randomization

Study Arms (2)

intervention

EXPERIMENTAL

The intervention group received usual care plus the DASHNa-CC intervention.

Behavioral: DASHNa-CCBehavioral: usual care

control

ACTIVE COMPARATOR

The control group received usual care.

Behavioral: usual care

Interventions

DASHNa-CCBEHAVIORAL

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.

intervention
usual careBEHAVIORAL

education booklet, encouragement of physician visit, use of public health resources if needed

controlintervention

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN PhD

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 20, 2015

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10