A Pilot Randomized Controlled Trial to Reduce Salt Intake Among Hypertensive Young Adults in Hong Kong

April 16, 2019 updated by: Dr. Pui-Hing Chau, The University of Hong Kong
A pilot randomized controlled trial will be conducted to investigate the feasibility and effectiveness of a salt intake reduction intervention to young hypertension patients in Hong Kong who had high salt intake.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Convenience sample will be recruited from the community in Hong Kong through different channels of promotion.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • School of Nursing, The University of Hong Kong

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

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • i) adults aged 18 to 44
  • ii) diagnosed hypertension or borderline hypertension
  • iii) complete collection of 24-hour urine at baseline
  • iv) 24-hour urinary sodium excretion above 2000mg at baseline
  • v) can communicate in Cantonese

Exclusion Criteria:

  • i) renal illnesses;
  • ii) taking diuretics;
  • iii) taking RAS blockers;
  • iv) attending or planning to attend new hypertension education programme or salt intake reduction programme during the study period.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Four-week weekly intervention to reduce salt intake.
Behavioral: Four-week weekly intervention to reduce salt intake
The intervention group will receive a four-week weekly intervention, about 15 minutes each. Two sessions will be face-to-face and two sessions will be on the phone. The participants will be informed of their 24-hour urinary sodium excretion at each measurement time once available.
Other: Control group
Usual government pamphlets.
Other: Usual government pamphlets
The control group will receive usual government pamphlets when they know their 24-hour urinary sodium excretion at baseline. However, they will not be informed of their follow-up urinary sodium excretion results immediately.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour urinary sodium excretion
Time Frame: 10-Week
Difference between the intervention and control group in the change in 24-hour urinary sodium excretion from baseline to the end of follow-up
10-Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health literacy on low salt intake
Time Frame: 10-Week
Difference between the intervention and control group in the change in health literacy on low salt intake measured with the validated Chinese Health Literacy Scale for Low Salt Consumption (CHLSalt-HK)
10-Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Chau Pui Hing, PhD, School of Nursing, The University of Hong Kong

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 (Actual)

October 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 16-280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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