Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity

Condition(s) studied

Investigational drug(s) / intervention(s)

HcELP_CMM: 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 Care: 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 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. 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;
3. 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:

1. If the HcELP\_CMM program is feasible and acceptable?
2. 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？
3. 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？

Eligibility

Primary outcome measure(s)

• Eligibility rate — 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 — 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 — 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 — 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. — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (3)

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