An interventional study of HcELP_CMM and Usual Care in Cardiometabolic Diseases and Multimorbidity, sponsored by The University of Hong Kong. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Supportive care
The goal of this study is to:
The main questions it aims to answer are:
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.
Exclusion Criteria:
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.
Behavioral: HcELP_CMM
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.
Behavioral: Usual Care
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.
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.
Eligibility rate
Eligibility rate will only be measured in the pilot part，which will be calculated as eligible participants divided by screened participants.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
Attrition rate
Attrition rate will only be measured in the pilot part, which will be calculated as participants dropping out divided by randomized participants.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Adverse events will be assessed through study completion (an average of 12 weeks) in the pilot part only.
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.
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
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.
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
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).
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
This outcome will be measured in the pilot part and in the full RCT part, which will be collected by self-reported method.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: This outcome will be collected at baseline.
Plan to share: No
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The University of Hong Kong