An interventional study of Receiving LSM messages. and Receiving brief pre-HTN messages. in Pre-hypertension, Lifestyle Modification and Blood Pressure Management, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Other
To assess the effectiveness of instant message-delivered personalised lifestyle modification (LSM) intervention for pre-hypertension (pre-HTN) management among community dwelling Chinese adults.
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.
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's planned enrollment of 256 is above the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
* LSM messages via instant messaging applications * Chat-type support messages via instant messaging applications
* A flyer with brief pre-HTN information which is distributed during the recruitment phase * Brief pre-HTN messages via instant messaging applications
24hr-systolic and diastolic BP
The BP will be measured by 24hr-ambulatory BP monitoring.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 6 months
Started May 2024 (actual). Primary completion is estimated for Sep 2024, 4 months after the start.
Of 56 non-industry interventional studies with no phase under Prehypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's planned 4 months is below that.
Counting every sponsor, half of 60 studies reached it within 20 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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