Instant Message-delivered Personalised Lifestyle Modification Intervention for Pre-hypertension Adults

NCT ID: NCT06504849

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

Systolic blood pressure (BP) of 120-139 or diastolic BP 80-89mmHg were previously described as 'high normal' or 'above-optimal', but have been re-defined as pre-hypertention (HTN) in the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure(JNC-7) in order to raise awareness regarding the risks of elevated BP and to emphasise healthcare professionals' roles in managing elevated blood pressures as part of primary HTN prevention. Prevalence of pre-HTN is significant, specifically reported as 36.4% of adults in a large-scale population study conducted in mainland China. Furthermore, evidence has shown that the incidence of clinical HTN over 4 years in people with pre-HTN is twice that of people with normal BP, of which approximately 17% had accelerated progression to more advanced stages of HTN. The data highlight that a significant proportion of populations at risk of developing HTN if pre-HTN remains undetected and unmanaged, and also the importance of screening for pre-HTN to initiate management and mitigate the risks associated with HTN.

Lifestyle modification (LSM) is the primary intervention for people with pre-HTN as they play a significant role in lowering BP without the use of pharmacological treatments. Both LSM interventions and pharmacological treatments have been recommended for people with HTN in clinical and public health guidelines. Ecological momentary intervention (EMI) is defined as a health intervention delivered though the mobile device's messaging functions, particularly instant messaging.In existing randomised controlled trials (RCTs), EMI also showed efficacy on LSM, including smoking cessation, diet control, psychological well-being, and weight loss. EMI can therefore serve as an important 'platform' to deliver the LSM intervention in a personalised, real-time and in-situ format.

Conditions

Pre-hypertension; Lifestyle Modification; Blood Pressure Management; Mobile Phone Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Receiving LSM messages.

Intervention Type: BEHAVIORAL

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

Control group

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.

Group Type: OTHER

Receiving brief pre-HTN messages.

Intervention Type: BEHAVIORAL

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

Interventions

Receiving LSM messages.

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

Intervention Type: BEHAVIORAL

Receiving brief pre-HTN messages.

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Aged ≥18 years;

3. Able to read and communicate in Chinese; and

4. Able to use mobile phone instant messaging function.

Exclusion Criteria

1. Ever diagnosis of HTN;

2. Ever diagnosis of cardiovascular diseases (CVDs);

3. Pregnant or <3-month post-partum;

4. Current diagnosis of psychiatric disease or currently taking a psychotropic drug; and

5. Currently participating in any type of BP reduction intervention.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Jung Jae Lee

Role: CONTACT

leejay@hku.hk

+852 3917 6971

Facility Contacts

LEE Jung Jae

Role: primary

leejay@hku.hk

3917 6971

Other Identifiers

Pre-HTN2024

Identifier Type: -

Identifier Source: org_study_id