NCT06504849

Brief Summary

To assess the effectiveness of instant message-delivered personalised lifestyle modification (LSM) intervention for pre-hypertension (pre-HTN) management among community dwelling Chinese adults.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 17, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

July 10, 2024

Last Update Submit

July 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 24hr-systolic and diastolic BP

    The BP will be measured by 24hr-ambulatory BP monitoring.

    6 months

Secondary Outcomes (7)

  • DASH diet adherence (Self-reported quesionnaire)

    6 months

  • Salt-intake literacy (Chinese Health Literacy Scale for Low Salt Consumption - Hong Kong, CHLSALT-HK)

    6 months

  • Physical activity (International Physical Activity Questionnaire - Short Form, IPAQ-SF)

    6 months

  • Body Mass Index (BMI)

    6 months

  • Psychological well-being (Patient Health Questionnaire, PHQ-4)

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group will receive personalised brief LSM messages (according to their unhealthy behaviours and preferences, screened during the baseline measurement) using instant messaging applications with an active self-BP monitor for 3 months. Chat-based support will also be given to the participants as an extension of the LSM messages.

Behavioral: Receiving LSM messages.

Control group

OTHER

The control group will receive a flyer with brief pre-HTN information, which is distributed during the recruitment phase, as well as brief pre-HTN messages via instant messaging applications.

Behavioral: Receiving brief pre-HTN messages.

Interventions

* LSM messages via instant messaging applications * Chat-type support messages via instant messaging applications

Intervention group

* A flyer with brief pre-HTN information which is distributed during the recruitment phase * Brief pre-HTN messages via instant messaging applications

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Systolic BP 120-139 or diastolic BP 80-89mmHg. The BP screening procedures and requirements (i.e., office BP measurement and ABPM) will strictly follow the International Society of Hypertension's Global Hypertension Practice Guidelines;
  • Aged ≥18 years;
  • Able to read and communicate in Chinese; and
  • Able to use mobile phone instant messaging function.

You may not qualify if:

  • Ever diagnosis of HTN;
  • Ever diagnosis of cardiovascular diseases (CVDs);
  • Pregnant or \<3-month post-partum;
  • Current diagnosis of psychiatric disease or currently taking a psychotropic drug; and
  • Currently participating in any type of BP reduction intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

PrehypertensionCell Phone Use

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCommunicationBehaviorSocial Behavior

Central Study Contacts

Jung Jae Lee

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 17, 2024

Study Start

May 1, 2024

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

July 17, 2024

Record last verified: 2024-03

Locations