HypertensionNCT02920437
A Pilot Randomized Controlled Trial to Reduce Salt Intake Among Hypertensive Young Adults in Hong Kong
A study testing Four-week weekly intervention to reduce salt intake and Usual government pamphlets in people with Hypertension, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Four-week weekly intervention to reduce salt intake and Usual government pamphlets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Convenience sample will be recruited from the community in Hong Kong through different channels of promotion.
- Conditions
- Hypertension
- Being tested
- Four-week weekly intervention to reduce salt intake, Usual government pamphlets
- Keywords
- dietary salt, 24 hour urinary sodium excretion, blood pressure, hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four-week weekly intervention to reduce salt intakeBehavioural
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.
Usual government pamphletsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Four-week weekly intervention to reduce salt intake. Receives: Behavioral: Four-week weekly intervention to reduce salt intake |
| Control group | Other | Usual government pamphlets. Receives: Other: Usual government pamphlets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10-Week
Secondary outcomes (1)
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)
Measured: 10-Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: The study cannot recruit the expected number of participants. Only 19 participants were recruited and no more new participant was recruited after that.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pui-Hing Chau, The University of Hong Kong
- Investigators
- Chau Pui Hing, PhD, Principal investigator, School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920437
- Sponsor's protocol ID
- UW 16-280
- Status last verified
- Apr 2019
- First submitted
- 29 Sep 2016
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial to Reduce Salt Intake Among Hypertensive Young Adults in Hong Kong
- ClinicalTrials.gov ID
- NCT02920437
- Acronym / sponsor ID
- UW 16-280
- Conditions
- Hypertension
- Keywords
- dietary salt, 24 hour urinary sodium excretion, blood pressure, hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study cannot recruit the expected number of participants. Only 19 participants were recruited and no more new participant was recruited after that.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Four-week weekly intervention to reduce salt intakeFour-week weekly intervention to reduce salt intake. |
| Control group | Other | Other: Usual government pamphletsUsual government pamphlets. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four-week weekly intervention to reduce salt intakeThe 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. | Behavioural | Intervention group |
| Usual government pamphletsThe 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. | Other | Control group |
Primary outcome
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
1 secondary outcome
Health literacy on low salt intake
Time frame: 10-Week
Results and safety
The study was stopped early (reason given: The study cannot recruit the expected number of participants. Only 19 participants were recruited and no more new participant was recruited after that.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chau Pui Hing, PhD principal investigator
School of Nursing, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four-week weekly intervention to reduce salt intake and Usual government pamphlets in people with Hypertension, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study cannot recruit the expected number of participants. Only 19 participants were recruited and no more new participant was recruited after that.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urinary sodium excretion (time frame: 10-Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.