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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HcELP_CMM | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility rate | Eligibility rate will only be measured in the pilot part，which will be calculated as eligible participants divided by screened participants. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Xi, PhD | Contact | 0086-15850061924 | u3010484@connect.hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Jing Xi, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gusu District Feng Men Street Community Health Service Center | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D000079102 | Empowerment |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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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.
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Masking Description
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| Usual Care | Behavioral | 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. |
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| Attrition rate | Attrition rate will only be measured in the pilot part, which will be calculated as participants dropping out divided by randomized participants. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Adverse events will be assessed through study completion (an average of 12 weeks) in the pilot part only. |
| 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | This outcome will be collected at baseline. |
| Gusu District Jinchang Street Bailian Community Health Service Center | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| Gusu District Shuang Ta Street Jinfan Community Health Service Center | Recruiting | Suzhou | Jiangsu | 215000 | China |
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