Cardiometabolic DiseasesHcELP_CMMNCT07158697
Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity
A study testing HcELP_CMM in people with Cardiometabolic Diseases and Multimorbidity, run by The University of Hong Kong at 3 sites in China.
Trial summary
The goal of this study is to: 1. assess the feasibility, acceptability, and the preliminary effects of the health chat for empowerment-based lifestyle planning for CMM (HcELP_CMM); 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiometabolic Diseases, Multimorbidity
- What is being tested?
- HcELP_CMM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 3 sitesChina
- Study dates
- 8 Sep 2025to 5 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or above；
- Diagnosed with cardiometabolic multimorbidity (CMM), which was defined as co-existing with two or more cardiometabolic diseases, including primary hypertension, type 2 diabetes, stroke, heart diseases (eg. coronary heart disease, arrhythmia, heart failure, myocardial infarction, and cardiac valve diseases), dyslipidemia, and obesity;
- Possessed a digital device installed with WeChat, as well as with an internet connection.
Who cannot join
- Contraindications to exercise according to American College of Sports Medicine (ACSM), such as severe musculoskeletal disorders, severe cardiovascular diseases, or spinal nerve injury;
- Diagnosis of psychiatric disease;
- Has impaired cognitive function as indicated by an Abbreviated Mental Test Score (AMTS) ≤6;
- Has impaired sensory or communication function which hider them participation in this program, such as hearing loss, vision loss, and unable to speak Mandarin.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Gusu District Feng Men Street Community Health Service Center
Suzhou, Jiangsu, 215000
Hongyan Meng, 0086-15106200578, menghongyan@suda.edu.cn
- Recruiting
Gusu District Jinchang Street Bailian Community Health Service Center
Suzhou, Jiangsu, 215000
Hongyan Meng, 0086-15106200578, menghongyan@suda.edu.cn
- Recruiting
Gusu District Shuang Ta Street Jinfan Community Health Service Center
Suzhou, Jiangsu, 215000
Hongyan Meng, 0086-15106200578, menghongyan@suda.edu.cn
About this study
Official title: Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity (HcELP_CMM) Program: a Randomized Controlled Trial Study
The goal of this study is to:
- assess the feasibility, acceptability, and the preliminary effects of the health chat for empowerment-based lifestyle planning for CMM (HcELP_CMM);
- examine the short-term effects of the HcELP_CMM program on lifestyle behaviors, cardiometabolic indicators, symptom burden, health related quality of life (HRQoL), psychological well-being, and physical function in patients with CMM;
- examine the long-term effects of the HcELP_CMM program on lifestyle behaviors, cardiometabolic indicators, symptom burden, HRQoL, psychological well-being, and physical function in patients with CMM.
Read more
The main questions it aims to answer are:
- If the HcELP_CMM program is feasible and acceptable?
- If the HcELP_CMM program has the potential to improve the lifestyle behaviors, cardiometabolic indicators, symptom burden, HRQoL, psychological well-being, and physical function in patients with CMM compared to the usual care group in the short-term？
- If the HcELP_CMM program has the potential to improve the lifestyle behaviors, cardiometabolic indicators, symptom burden, HRQoL, psychological well-being, and physical function in patients with CMM compared to the usual care group in the long-term？
Read the detailed description
This study has two parts. Part 1 is a sequential mixed-method pilot study consisted of a single-blind, parallel-group, two-arm randomized controlled trial followed by a qualitative descriptive study. Part 2 is a full single-blind, parallel-group, two-arm randomized controlled trial study. In these two parts, participants with CMM will be randomly assigned to either an intervention group to receive the HcELP_CMM intervention or a control group to receive the usual care in a 1:1 ratio.
For part 1, the intervention group will participate in the 12-week HcELP_CMM project. The intervention consists of two phases. Phase 1 involves an individualized face-to-face goal-oriented health counseling conducted by the researcher in a private meeting room at the community health care centers (CHCCs) within one week after random allocation, lasting about 1 hour. This phase includes four core steps: 1) risk diagnostics by assessing symptom burden, lifestyle behaviors, and past experience of lifestyle modefication; 2) risk communication by generating and analyzing a symptom-lifestyle report; 3) goal setting by conducting a brief health education based on lifestyle behaviors guidelines for CMM and developing personalized goals and detailed action plan, and measurable bio-feedback parameters; and 4) strengthen commitment to lifestyle change by making a behavior commitment. Phase 2 is WeChat-based enhanced healthy lifestyle empowerment, which will be delivered individually through the WeChat platform using the official account, chat function, and synchronized online video between weeks 2 and 12. It includes two modules:1) lifestyle change for better; and 2) effective lifestyle maintenance. In Module 1, participants will implement action plans weekly, and a source hub of empowerment videos will be provided to promote the implementation of action plan. Additionally, participants will self-evaluate lifestyle behaviors, fill out and upload the logbook of self-assessment lifestyle behavior weekly. In Module 2, participants will self-monitor bio-feedback parameters, fill out and upload the logbook of self-monitoring biofeedback parameters weekly. Furthermore, they will receive bi-weekly health counseling through synchronized online videos on the WeChat platform, with each session lasting about 20 minutes. Participants were then encouraged to integrate the discussed coping strategies into their daily routines.The control group will receive usual care provided by the CHCCs, which included general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention. Additionally, some participants in the intervention group will undergo semi-structured interviews via synchronized online video through the WeChat platform in1 week after the intervention concludes, lasting 1 hour. The interview will be audio recorded. Outcome data collection will occur in 1 week after the completion of the intervention through face-to-face interviews at the CHCCs, lasting about 30 minutes.
For part 2, the intervention group will participate in the 12-week HcELP_CMM project. The intervention consists of two phases. Phase 1 involves an individualized face-to-face goal-oriented health counseling conducted by the researcher in a private meeting room at the community health care centers (CHCCs) within one week after random allocation, lasting about 1 hour. This phase includes four core steps: 1) risk diagnostics by assessing symptom burden, lifestyle behaviors, and past experience of lifestyle modefication; 2) risk communication by generating and analyzing a symptom-lifestyle report; 3) goal setting by conducting a brief health education based on lifestyle behaviors guidelines for CMM and developing personalized goals and detailed action plan, and measurable bio-feedback parameters; and 4) strengthen commitment to lifestyle change by making a behavior commitment. Phase 2 is WeChat-based enhanced healthy lifestyle empowerment, which will be delivered individually through the WeChat platform using the official account, chat function, and synchronized online video between weeks 2 and 12. It includes two modules:1) lifestyle change for better; and 2) effective lifestyle maintenance. In Module 1, participants will implement action plans weekly, and a source hub of empowerment videos will be provided to promote the implementation of action plan. Additionally, participants will self-evaluate lifestyle behaviors, fill out and upload the logbook of self-assessment lifestyle behavior weekly. In Module 2, participants will self-monitor bio-feedback parameters, fill out and upload the logbook of self-monitoring biofeedback parameters weekly. Beside, a small Wechat group contained 8-10 participants will be created to facilitate communication and mutual support among participants. Furthermore, they will receive bi-weekly health counseling through synchronized online videos on the WeChat platform, with each session lasting about 20 minutes. Participants were then encouraged to integrate the discussed coping strategies into their daily routines.The control group will receive usual care provided by the CHCCs, which included general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention. Besides, all participants in the intervention and control groups will undergo a 2-month follow-up after the intervention. During the follow-up period, all participants will maintain their daily lifestyle at home and obtained WeChat-based follow-up bi-weekly. Followup communications include: general well-being assessments; disease management monitoring; and addressing disease related inquiries. Outcome data collection will occur in 1 week after the completion of the intervention and follow-up through face-to-face interviews at the CHCCs, lasting about 30 minutes.
- Conditions
- Cardiometabolic Diseases, Multimorbidity
- Being tested
- HcELP_CMM, Usual Care
- Keywords
- Cardiometabolic multimorbidity, Empowerment, Patient-centered, Self-management, Intervention
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HcELP_CMMBehavioural
Participants in this group will attend a 12-week HcELP_CMM program. This program is a hybrid intervention involving two phases: 1) face-to-face goal-oriented health counseling (week 1); 2) WeChat-based enhanced healthy lifestyle empowerment delivered by WeChat platform utilizing the official account, chat function, and synchronized online videos to integrate and sustain healthy lifestyle (weekly, week 2-12). Phase 1 covers 4 core steps: 1) risk diagnostics; 2) risk communication; 3) goal setting; and 4)strengthen commitment to lifestyle change. Phase 2 covers two modules: 1) lifestyle change for better, and 2) effective lifestyle maintenance.
Usual CareBehavioural
Participants in this group will receive usual care provided by the CHCCs, which will include general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| HcELP_CMM | Experimental | Participants in the arm will attend a 12-week HcELP_CMM program. This program is a hybrid intervention involving two phases: 1) face-to-face goal-oriented health counseling (week 1); 2) WeChat-based enhanced healthy lifestyle empowerment delivered by WeChat platform utilizing the official account, chat function, and synchronized online videos to integrate and sustain healthy lifestyle (weekly, week 2-12). Phase 1 covers 4 core steps: 1) risk diagnostics; 2) risk communication; 3) goal setting; and 4)strengthen commitment to lifestyle change. Phase 2 covers two modules: 1) lifestyle change for better, and 2) effective lifestyle maintenance. Receives: Behavioral: HcELP_CMM |
| Usual care | Active comparator | Participants in the arm will receive usual care provided by the CHCCs, which will include general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility rate
Eligibility rate will only be measured in the pilot part，which will be calculated as eligible participants divided by screened participants.
Measured: Eligibility rate will be assessed at baseline only in the pilot part.
Recruitment rate
Recruitment rate will only be measured in the pilot part, which will be calculated as randomized participants divided by eligible participants.
Measured: Recruitment rate will be assessed at baseline only in the pilot part.
Adherence rate
Adherence rate will only be measured in the pilot part, which will be calculated as participants who completed the program divided by randomized participants.
Measured: Adherence rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Reasons for refusal to participate the program
Reasons for refusal to participate the program will only be measured in the pilot part, which will be obtained from individual review.
Measured: Reasons for refusal to participate the program will be assessed at baseline only in the pilot part.
Participant's engagement experiences, feedback about the study design, and perceived program effects.
Participant's engagement experiences, feedback about the study design, and perceived program effects will only be measured in the pilot part, which will be explored by the individualized semi-structured qualitative interviews with participants in the HcELP_CMM group through synchronized online video interviewing via WeChat platform.
Measured: Participant's engagement experiences, feedback about the study design, and perceived program effects will be measured within one week after the completion of the intervention only in the pilot part.
Attrition rate
Attrition rate will only be measured in the pilot part, which will be calculated as participants dropping out divided by randomized participants.
Measured: Attrition rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Engagement rate
Engagement rate will only be measured in the pilot part, which will be calculated as the number of sessions of structed activities participants attended.
Measured: Engagement rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Reasons of non-engagement
Reasons of non-engagement will only be measured in the pilot part, which will be obtained from individual review.
Measured: Reasons of non-engagement will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Exposure to empowerment videos
Exposure to empowerment videos will only be measured in the pilot part, which will be calculated as ratio of views to videos distributed.
Measured: Exposure to empowerment videos will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Completion rate
Completion rate will only be measured in the pilot part, which will be calculated as proportion of participants attending ≥80% of planned structured sessions.
Measured: Completion rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Goal attainment level
Goal attainment level will only be measured in the pilot part, which will be calculated from submitted lifestyle self-evaluation logbooks.
Measured: Goal attainment level will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Researcher-participant dialogues
Researcher-participant dialogues will only be measured in the pilot part, which will be analyzed from the recordings in WeChat.
Measured: Researcher-participant dialogues will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Adverse events
Adverse events will only be measured in the pilot part, which will be monitored throughout the intervention via self-reported adverse events.
Measured: Adverse events will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Secondary outcomes (25)
Lifestyle behaviors
This outcome will be assessed both in the pilot part and full RCT part. Lifestyle behaviors will be measured by the Health Promoting Lifestyle Profile II (HPLP-II). It encompassed 52 items with six aspects of health promotion behaviors including nutrition, interpersonal support, stress management, exercise, health responsibility, and self-actualization. The HPLP-II uses a four-point scale with 1-4 representing always to never with a total score ranging from 52 to 208 and a higher score indicates better health behavior. It has been translated and validated in China, and the Chinese version has a Cronbach's α coefficient from 0.84 to 0.91.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Blood pressure
This outcome will be assessed in the pilot part and in the full RCT part. Blood pressure will be taken in the sitting position using an electronic sphygmomanometer. Before measurement, patients will be required to sit still for more than 5 min. The average of three consecutive measurements will be considered the effective blood pressure.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Capillary fasting plasma glucose
This outcome will be assessed in the pilot part and in the full RCT part, which will be determined by using a Contour TS blood glucose meter and supporting test strips (BAYER, Germany).
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Waist circumference
This outcome will be assessed in the pilot part and in the full RCT part，which will be measured with a flexible plastic tape measure at the navel position after the patient exhaled.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Body Mass Index
This outcome will be assessed in the pilot part and in the full RCT part，which will be calculated for each patient by dividing their weight in kilograms by the square of their height in meters.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Symptom burden
This outcome will be assessed in the pilot part and in the full RCT part. It will be assessed by the Memorial Symptom Assessment Scale (MSAS). MSAS includes 32 commonly occurring symptoms experienced during the preceding week in terms of three dimensions - frequency, severity and distress - for 24 symptoms, and two dimensions - severity and distress -for 8 symptoms. The prevalence of each symptom is answered by yes/no; frequency on a four-point scale(1-4): rarely, occasionally, frequently or almost constantly; severity on a four-point scale(1-4): slight, moderate, severe, or very severe; and distress on a five-point scale(0-4) - not at all, a little bit, somewhat, quite a bit or very much. One item related to sexual was excluded because discussing sex can cause discomfort among Chinese participants. The total symptom burden score per patient is the mean of all symptom burden scores.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Health-related quality of life
This outcome will be assessed in the pilot part and in the full RCT part. The 12-item Short Form Health Survey (SF-12) will be used to assess the Health-related quality of life. It is a simplified version of the 36-item Short Form Health Survey (SF-36), but it's almost equivalent to SF-36 and easier to understand and complete. It evaluates 8 dimensions, including general health, physical functioning , role-physical, bodily pain for physical component summary, and vitality, social functioning, role-emotional, and mental health for mental component summary. The total score of physical component summary and mental component summary both ranges from 0 to 100, and a higher score means better physical or mental status. SF-12 has good reliability, content, and construct validity.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Depression
This outcome will be assessed in the pilot part and in the full RCT part. Depression will be measured with the Chinese version of the Patient Health Questionnaire-9 (PHQ-9). The scale comprises nine items, with each item rated on a 4-point scale from 0 (not at all) to 3 (almost every day). The total score ranges from 0 to 27, with higher scores indicating more severe depression. The cut-off points of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. In this study, we used a score of 5 as the cut-off point, with a score greater than or equal to 5 indicating the presence of depressive symptoms. The Cronbach's α coefficient of the total scale is 0.86 for the Chinese general population.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Handgrip
This outcome will be measured in the pilot part and in the full RCT part, which will be measured twice by a dynamometer in the dominant hand and the maximum value will be recorded.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
5-times-sit-to-stand test
This outcome will be measured in the pilot part and in the full RCT part. Participants will be asked to stand up straight and sit as fast as possible on a standard-height chair without armrests, five times without stopping. The completion time will be recorded.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Time up-and-go test
This outcome will be measured in the pilot part and in the full RCT part. Participants will be instructed to stand up from a chair, walk three meters at their usual speed, turn, walk back to the chair, and sit down. The time will be recorded.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
4-meter gait speed
This outcome will be measured in the pilot part and in the full RCT part. Participants will be required to walk 4-m distance at their usual speed twice and the faster time will be recorded.
Measured: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Age
This outcome will be measured in the pilot part and in the full RCT part, which will be collected by self-reported method.
Measured: This outcome will be collected at baseline.
Gender
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized into male and female.
Measured: This outcome will be collected at baseline.
Education level
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized into primary school and below, middle school, high school, and bachelor's degree and above.
Measured: This outcome will be collected at baseline.
Marital status
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized into married, single, divorced, and widowed.
Measured: This outcome will be collected at baseline.
Employment status
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized as employment and unemployment.
Measured: This outcome will be collected at baseline.
Income
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized into less than 5,000, 5,000-10,000, and more than 10,000.
Measured: This outcome will be collected at baseline.
Living conditions
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized into living alone and living with others.
Measured: This outcome will be collected at baseline.
Drinking status
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized into never, former drinker, and current drinker.
Measured: This outcome will be collected at baseline.
Smoking status
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized into never, former smoker, and current smoker.
Measured: This outcome will be collected at baseline.
Sleep duration at night
This outcome will be measured in the pilot part and in the full RCT part, which will be recorded as the hours of sleep at night.
Measured: This outcome will be collected at baseline.
Sleep quality
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized into very poor, poor, fair, good, and very good.
Measured: This outcome will be collected at baseline.
Exercise habit
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized into with exercise habit and without exercise habit. Exercise habit is defined as exercising at least three times per week, with each session lasting no less than 30 minutes.
Measured: This outcome will be collected at baseline.
Polypharmacy
This outcome will be measured in the pilot part and in the full RCT part, which will be categorized into yes and no. Polypharmacy is defined as the use of five or more medications.
Measured: This outcome will be collected at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start8 Sep 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an intervention group to receive the HcELP\_CMM program intervention or a control group to receive the usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Xi, The University of Hong Kong
- Investigators
- Jing Xi, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158697
- Sponsor's protocol ID
- UW 25-383
- Acronym
- HcELP_CMM
- Status last verified
- May 2026
- First submitted
- 21 Aug 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity (HcELP_CMM) Program: a Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT07158697
- Acronym / sponsor ID
- HcELP_CMM / UW 25-383
- Conditions
- Cardiometabolic Diseases, Multimorbidity
- Keywords
- Cardiometabolic multimorbidity, Empowerment, Patient-centered, Self-management, Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 8 Sep 2025 (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.
The goal of this study is to:
- assess the feasibility, acceptability, and the preliminary effects of the health chat for empowerment-based lifestyle planning for CMM (HcELP_CMM);
- examine the short-term effects of the HcELP_CMM program on lifestyle behaviors, cardiometabolic indicators, symptom burden, health related quality of life (HRQoL), psychological well-being, and physical function in patients with CMM;
- examine the long-term effects of the HcELP_CMM program on lifestyle behaviors, cardiometabolic indicators, symptom burden, HRQoL, psychological well-being, and physical function in patients with CMM.
The main questions it aims to answer are:
- If the HcELP_CMM program is feasible and acceptable?
- If the HcELP_CMM program has the potential to improve the lifestyle behaviors, cardiometabolic indicators, symptom burden, HRQoL, psychological well-being, and physical function in patients with CMM compared to the usual care group in the short-term？
- If the HcELP_CMM program has the potential to improve the lifestyle behaviors, cardiometabolic indicators, symptom burden, HRQoL, psychological well-being, and physical function in patients with CMM compared to the usual care group in the long-term？
Detailed description
This study has two parts. Part 1 is a sequential mixed-method pilot study consisted of a single-blind, parallel-group, two-arm randomized controlled trial followed by a qualitative descriptive study. Part 2 is a full single-blind, parallel-group, two-arm randomized controlled trial study. In these two parts, participants with CMM will be randomly assigned to either an intervention group to receive the HcELP_CMM intervention or a control group to receive the usual care in a 1:1 ratio.
For part 1, the intervention group will participate in the 12-week HcELP_CMM project. The intervention consists of two phases. Phase 1 involves an individualized face-to-face goal-oriented health counseling conducted by the researcher in a private meeting room at the community health care centers (CHCCs) within one week after random allocation, lasting about 1 hour. This phase includes four core steps: 1) risk diagnostics by assessing symptom burden, lifestyle behaviors, and past experience of lifestyle modefication; 2) risk communication by generating and analyzing a symptom-lifestyle report; 3) goal setting by conducting a brief health education based on lifestyle behaviors guidelines for CMM and developing personalized goals and detailed action plan, and measurable bio-feedback parameters; and 4) strengthen commitment to lifestyle change by making a behavior commitment. Phase 2 is WeChat-based enhanced healthy lifestyle empowerment, which will be delivered individually through the WeChat platform using the official account, chat function, and synchronized online video between weeks 2 and 12. It includes two modules:1) lifestyle change for better; and 2) effective lifestyle maintenance. In Module 1, participants will implement action plans weekly, and a source hub of empowerment videos will be provided to promote the implementation of action plan. Additionally, participants will self-evaluate lifestyle behaviors, fill out and upload the logbook of self-assessment lifestyle behavior weekly. In Module 2, participants will self-monitor bio-feedback parameters, fill out and upload the logbook of self-monitoring biofeedback parameters weekly. Furthermore, they will receive bi-weekly health counseling through synchronized online videos on the WeChat platform, with each session lasting about 20 minutes. Participants were then encouraged to integrate the discussed coping strategies into their daily routines.The control group will receive usual care provided by the CHCCs, which included general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention. Additionally, some participants in the intervention group will undergo semi-structured interviews via synchronized online video through the WeChat platform in1 week after the intervention concludes, lasting 1 hour. The interview will be audio recorded. Outcome data collection will occur in 1 week after the completion of the intervention through face-to-face interviews at the CHCCs, lasting about 30 minutes.
For part 2, the intervention group will participate in the 12-week HcELP_CMM project. The intervention consists of two phases. Phase 1 involves an individualized face-to-face goal-oriented health counseling conducted by the researcher in a private meeting room at the community health care centers (CHCCs) within one week after random allocation, lasting about 1 hour. This phase includes four core steps: 1) risk diagnostics by assessing symptom burden, lifestyle behaviors, and past experience of lifestyle modefication; 2) risk communication by generating and analyzing a symptom-lifestyle report; 3) goal setting by conducting a brief health education based on lifestyle behaviors guidelines for CMM and developing personalized goals and detailed action plan, and measurable bio-feedback parameters; and 4) strengthen commitment to lifestyle change by making a behavior commitment. Phase 2 is WeChat-based enhanced healthy lifestyle empowerment, which will be delivered individually through the WeChat platform using the official account, chat function, and synchronized online video between weeks 2 and 12. It includes two modules:1) lifestyle change for better; and 2) effective lifestyle maintenance. In Module 1, participants will implement action plans weekly, and a source hub of empowerment videos will be provided to promote the implementation of action plan. Additionally, participants will self-evaluate lifestyle behaviors, fill out and upload the logbook of self-assessment lifestyle behavior weekly. In Module 2, participants will self-monitor bio-feedback parameters, fill out and upload the logbook of self-monitoring biofeedback parameters weekly. Beside, a small Wechat group contained 8-10 participants will be created to facilitate communication and mutual support among participants. Furthermore, they will receive bi-weekly health counseling through synchronized online videos on the WeChat platform, with each session lasting about 20 minutes. Participants were then encouraged to integrate the discussed coping strategies into their daily routines.The control group will receive usual care provided by the CHCCs, which included general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention. Besides, all participants in the intervention and control groups will undergo a 2-month follow-up after the intervention. During the follow-up period, all participants will maintain their daily lifestyle at home and obtained WeChat-based follow-up bi-weekly. Followup communications include: general well-being assessments; disease management monitoring; and addressing disease related inquiries. Outcome data collection will occur in 1 week after the completion of the intervention and follow-up through face-to-face interviews at the CHCCs, lasting about 30 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention group to receive the HcELP_CMM program intervention or a control group to receive the usual care.
| Arm | Type | Receives |
|---|---|---|
| HcELP_CMM | Experimental | Behavioral: HcELP_CMMParticipants in the arm will attend a 12-week HcELP_CMM program. This program is a hybrid intervention involving two phases: 1) face-to-face goal-oriented health counseling (week 1); 2) WeChat-based enhanced healthy lifestyle empowerment delivered by WeChat platform utilizing the official account, chat function, and synchronized online videos to integrate and sustain healthy lifestyle (weekly, week 2-12). Phase 1 covers 4 core steps: 1) risk diagnostics; 2) risk communication; 3) goal setting; and 4)strengthen commitment to lifestyle change. Phase 2 covers two modules: 1) lifestyle change for better, and 2) effective lifestyle maintenance. |
| Usual care | Active comparator | Behavioral: Usual CareParticipants in the arm will receive usual care provided by the CHCCs, which will include general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or above；
- Diagnosed with cardiometabolic multimorbidity (CMM), which was defined as co-existing with two or more cardiometabolic diseases, including primary hypertension, type 2 diabetes, stroke, heart diseases (eg. coronary heart disease, arrhythmia, heart failure, myocardial infarction, and cardiac valve diseases), dyslipidemia, and obesity;
- Possessed a digital device installed with WeChat, as well as with an internet connection.
Key exclusion criteria (4 listed)
- Contraindications to exercise according to American College of Sports Medicine (ACSM), such as severe musculoskeletal disorders, severe cardiovascular diseases, or spinal nerve injury;
- Diagnosis of psychiatric disease;
- Has impaired cognitive function as indicated by an Abbreviated Mental Test Score (AMTS) ≤6;
- Has impaired sensory or communication function which hider them participation in this program, such as hearing loss, vision loss, and unable to speak Mandarin.
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 |
|---|---|---|
| HcELP_CMMParticipants in this group will attend a 12-week HcELP_CMM program. This program is a hybrid intervention involving two phases: 1) face-to-face goal-oriented health counseling (week 1); 2) WeChat-based enhanced healthy lifestyle empowerment delivered by WeChat platform utilizing the official account, chat function, and synchronized online videos to integrate and sustain healthy lifestyle (weekly, week 2-12). Phase 1 covers 4 core steps: 1) risk diagnostics; 2) risk communication; 3) goal setting; and 4)strengthen commitment to lifestyle change. Phase 2 covers two modules: 1) lifestyle change for better, and 2) effective lifestyle maintenance. | Behavioural | HcELP_CMM |
| Usual CareParticipants in this group will receive usual care provided by the CHCCs, which will include general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention. | Behavioural | Usual care |
Primary outcome
Eligibility rate
Time frame: Eligibility rate will be assessed at baseline only in the pilot part.
Eligibility rate will only be measured in the pilot part，which will be calculated as eligible participants divided by screened participants.
Recruitment rate
Time frame: Recruitment rate will be assessed at baseline only in the pilot part.
Recruitment rate will only be measured in the pilot part, which will be calculated as randomized participants divided by eligible participants.
Adherence rate
Time frame: Adherence rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Adherence rate will only be measured in the pilot part, which will be calculated as participants who completed the program divided by randomized participants.
Reasons for refusal to participate the program
Time frame: Reasons for refusal to participate the program will be assessed at baseline only in the pilot part.
Reasons for refusal to participate the program will only be measured in the pilot part, which will be obtained from individual review.
Participant's engagement experiences, feedback about the study design, and perceived program effects.
Time frame: Participant's engagement experiences, feedback about the study design, and perceived program effects will be measured within one week after the completion of the intervention only in the pilot part.
Participant's engagement experiences, feedback about the study design, and perceived program effects will only be measured in the pilot part, which will be explored by the individualized semi-structured qualitative interviews with participants in the HcELP_CMM group through synchronized online video interviewing via WeChat platform.
Attrition rate
Time frame: Attrition rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Attrition rate will only be measured in the pilot part, which will be calculated as participants dropping out divided by randomized participants.
Engagement rate
Time frame: Engagement rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Engagement rate will only be measured in the pilot part, which will be calculated as the number of sessions of structed activities participants attended.
Reasons of non-engagement
Time frame: Reasons of non-engagement will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Reasons of non-engagement will only be measured in the pilot part, which will be obtained from individual review.
Exposure to empowerment videos
Time frame: Exposure to empowerment videos will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Exposure to empowerment videos will only be measured in the pilot part, which will be calculated as ratio of views to videos distributed.
Completion rate
Time frame: Completion rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Completion rate will only be measured in the pilot part, which will be calculated as proportion of participants attending ≥80% of planned structured sessions.
Goal attainment level
Time frame: Goal attainment level will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Goal attainment level will only be measured in the pilot part, which will be calculated from submitted lifestyle self-evaluation logbooks.
Researcher-participant dialogues
Time frame: Researcher-participant dialogues will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Researcher-participant dialogues will only be measured in the pilot part, which will be analyzed from the recordings in WeChat.
Adverse events
Time frame: Adverse events will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Adverse events will only be measured in the pilot part, which will be monitored throughout the intervention via self-reported adverse events.
25 secondary outcomes
Lifestyle behaviors
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Blood pressure
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Capillary fasting plasma glucose
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Waist circumference
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Body Mass Index
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Symptom burden
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Health-related quality of life
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Depression
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Handgrip
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
5-times-sit-to-stand test
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Time up-and-go test
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
4-meter gait speed
Time frame: In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.
Age
Time frame: This outcome will be collected at baseline.
Gender
Time frame: This outcome will be collected at baseline.
Education level
Time frame: This outcome will be collected at baseline.
Marital status
Time frame: This outcome will be collected at baseline.
Employment status
Time frame: This outcome will be collected at baseline.
Income
Time frame: This outcome will be collected at baseline.
Living conditions
Time frame: This outcome will be collected at baseline.
Drinking status
Time frame: This outcome will be collected at baseline.
Smoking status
Time frame: This outcome will be collected at baseline.
Sleep duration at night
Time frame: This outcome will be collected at baseline.
Sleep quality
Time frame: This outcome will be collected at baseline.
Exercise habit
Time frame: This outcome will be collected at baseline.
Polypharmacy
Time frame: This outcome will be collected at baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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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.
Jing Xi, PhD principal investigator
The University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HcELP_CMM in people with Cardiometabolic Diseases and Multimorbidity, run by The University of Hong Kong at 3 sites in China.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Xi, PhD (0086-15850061924, u3010484@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility rate (time frame: Eligibility rate will be assessed at baseline only in the pilot part.). The study lists 13 primary outcomes in all. 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 11 May 2026.