Pre-hypertensionNCT06504849
Instant Message-delivered Personalised Lifestyle Modification Intervention for Pre-hypertension Adults
A study testing Receiving LSM messages. and Receiving brief pre-HTN messages. in people with Pre-hypertension and Lifestyle Modification, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pre-hypertension, Lifestyle Modification, Blood Pressure Management
- What is being tested?
- Receiving LSM messages. and Receiving brief pre-HTN messages.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong
LEE Jung Jae, 3917 6971, leejay@hku.hk
About this study
Official title: 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.
Read the 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.
- Being tested
- Receiving LSM messages., Receiving brief pre-HTN messages.
- Medical subject headings
- Prehypertension, Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving LSM messages.Behavioural
- LSM messages via instant messaging applications
- Chat-type support messages via instant messaging applications
Receiving brief pre-HTN messages.Behavioural
- A flyer with brief pre-HTN information which is distributed during the recruitment phase
- Brief pre-HTN messages via instant messaging applications
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Receiving brief pre-HTN messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24hr-systolic and diastolic BP
The BP will be measured by 24hr-ambulatory BP monitoring.
Measured: 6 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 May 2024
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-hypertensionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504849
- Sponsor's protocol ID
- Pre-HTN2024
- Status last verified
- Mar 2024
- First submitted
- 10 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instant Message-delivered Personalised Lifestyle Modification Intervention for Pre-hypertension Management Among Community Dwelling Adults: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06504849
- Acronym / sponsor ID
- Pre-HTN2024
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Receiving LSM messages.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. |
| Control group | Other | Behavioral: Receiving brief pre-HTN 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receiving LSM messages.* LSM messages via instant messaging applications * Chat-type support messages via instant messaging applications | Behavioural | Intervention group |
| 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 | Behavioural | Control group |
Primary outcome
24hr-systolic and diastolic BP
Time frame: 6 months
The BP will be measured by 24hr-ambulatory BP monitoring.
7 secondary outcomes
DASH diet adherence (Self-reported quesionnaire)
Time frame: 6 months
Salt-intake literacy (Chinese Health Literacy Scale for Low Salt Consumption - Hong Kong, CHLSALT-HK)
Time frame: 6 months
Physical activity (International Physical Activity Questionnaire - Short Form, IPAQ-SF)
Time frame: 6 months
Body Mass Index (BMI)
Time frame: 6 months
Psychological well-being (Patient Health Questionnaire, PHQ-4)
Time frame: 6 months
Quality of life (EuroQol 5-dimension 5-level questionnaire, EQ-5D-5L)
Time frame: 6 months
Feedback on instant message-delivered personalised lifestyle modification intervention
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receiving LSM messages. and Receiving brief pre-HTN messages. in people with Pre-hypertension and Lifestyle Modification, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Jae Lee (+852 3917 6971, leejay@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24hr-systolic and diastolic BP (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.