NCT02920437

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

September 29, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

September 29, 2016

Last Update Submit

April 16, 2019

Conditions

Keywords

dietary salt24 hour urinary sodium excretionblood pressurehypertension

Outcome Measures

Primary Outcomes (1)

  • 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

    10-Week

Secondary Outcomes (1)

  • Health literacy on low salt intake

    10-Week

Study Arms (2)

Intervention group

EXPERIMENTAL

Four-week weekly intervention to reduce salt intake.

Behavioral: Four-week weekly intervention to reduce salt intake

Control group

OTHER

Usual government pamphlets.

Other: Usual government pamphlets

Interventions

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 group

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.

Control group

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Chau Pui Hing, PhD

    School of Nursing, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 29, 2016

First Posted

September 30, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations