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

Instant Message-delivered Personalised Lifestyle Modification Intervention for Pre-hypertension Management Among Community Dwelling Adults: a Randomised Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Mobile Phone Use; Lifestyle Modification; Pre-hypertension; Blood Pressure Management
• Intervention / Treatment: Behavioral: Receiving LSM messages.; Behavioral: Receiving brief pre-HTN messages.

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.

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung Jae Lee; Phone Number: +852 3917 6971; Email: leejay@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • University of Hong Kong
    • Contact: LEE Jung Jae; Phone Number: 3917 6971; Email: leejay@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Receiving LSM messages.; LSM messages via instant messaging applications; Chat-type support messages via instant messaging applications
Other: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hr-systolic and diastolic BP	The BP will be measured by 24hr-ambulatory BP monitoring.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASH diet adherence (Self-reported quesionnaire)	A self-reported questionnaire will be utilized to assess adherence to the DASH diet, based on the portions consumed in the previous week as reported by the participants.	6 months
Salt-intake literacy (Chinese Health Literacy Scale for Low Salt Consumption - Hong Kong, CHLSALT-HK)	The 49-item CHLSalt-HK had a possible score range of 0 to 98, with a higher score indicating higher health literacy related to salt intake.	6 months
Physical activity (International Physical Activity Questionnaire - Short Form, IPAQ-SF)	The IPAQ-SF is designed to measure the level of physical activity among adults over a week, including vigorous and moderate activities, walking, and sitting time. Scoring is based on the type, frequency, and duration of activities, converting activity levels into Metabolic Equivalent Task (MET) minutes per week to assess overall physical activity. Vigorous activities are calculated at 8 METs per minute, moderate activities at 4 METs, and walking at 3.3 METs. The total activity score is the sum of MET minutes per week for all activities, categorizing participants into low, moderate, or high physical activity levels based on their total score.	6 months
Body Mass Index (BMI)	BMI is calculated by dividing an individual's weight in kilograms by their height in meters squared. Higher BMI can indicate higher body fatness.	6 months
Psychological well-being (Patient Health Questionnaire, PHQ-4)	A 4-item scale with score ranging from 0 to 12, higher scores indicate higher severity of mental health problems.	6 months
Quality of life (EuroQol 5-dimension 5-level questionnaire, EQ-5D-5L)	The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity, with scores ranging from -0.864 to 1, where higher scores indicate better quality of life. Additionally, it includes a visual analogue scale (VAS), ranging from 0 (the worst health imaginable) to 100 (the best health imaginable).	6 months
Feedback on instant message-delivered personalised lifestyle modification intervention	Feedback on the blood pressure management program will be collected, focusing on various aspects such as perceived usefulness and willingness to recommend the program. Each aspect will be evaluated using a 5-point Likert scale, where higher scores indicate more positive evaluations.	6 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Prehypertension
• Other Study ID Numbers: Pre-HTN2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No