Back to resultsA Pilot Randomized Controlled Trial to Reduce Salt Intake Among Hypertensive Young Adults in Hong Kong
Primary Purpose
Hypertension
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Four-week weekly intervention to reduce salt intake
Usual government pamphlets
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring dietary salt, 24 hour urinary sodium excretion, blood pressure, hypertension
Eligibility Criteria
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.
Sites / Locations
- School of Nursing, The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention group
Control group
Arm Description
Four-week weekly intervention to reduce salt intake.
Usual government pamphlets.
Outcomes
Primary Outcome Measures
24-hour urinary sodium excretion
Difference between the intervention and control group in the change in 24-hour urinary sodium excretion from baseline to the end of follow-up
Secondary Outcome Measures
Health literacy on low salt intake
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)
Full Information
NCT ID
NCT02920437
First Posted
September 29, 2016
Last Updated
April 16, 2019
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02920437
Brief Title
A Pilot Randomized Controlled Trial to Reduce Salt Intake Among Hypertensive Young Adults in Hong Kong
Official Title
A Pilot Randomized Controlled Trial to Reduce Salt Intake Among Hypertensive Young Adults in Hong Kong
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
The study cannot recruit the expected number of participants. Only 19 participants were recruited and no more new participant was recruited after that.
Study Start Date
October 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Convenience sample will be recruited from the community in Hong Kong through different channels of promotion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
dietary salt, 24 hour urinary sodium excretion, blood pressure, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Four-week weekly intervention to reduce salt intake.
Arm Title
Control group
Arm Type
Other
Arm Description
Usual government pamphlets.
Intervention Type
Behavioral
Intervention Name(s)
Four-week weekly intervention to reduce salt intake
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual government pamphlets
Intervention Description
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.
Primary Outcome Measure Information:
Title
24-hour urinary sodium excretion
Description
Difference between the intervention and control group in the change in 24-hour urinary sodium excretion from baseline to the end of follow-up
Time Frame
10-Week
Secondary Outcome Measure Information:
Title
Health literacy on low salt intake
Description
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)
Time Frame
10-Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chau Pui Hing, PhD
Organizational Affiliation
School of Nursing, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, The University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Randomized Controlled Trial to Reduce Salt Intake Among Hypertensive Young Adults in Hong Kong
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