NCT07158697

Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity

Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity (HcELP_CMM) Program: a Randomized Controlled Trial Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to: 1. assess the feasibility of the health chat for empowerment-based lifestyle planning for cardiometabolic multimorbidity (HcELP\_CMM); 2. examine the immediate 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; 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? 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？

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: It involves an individualized face-to-face meeting 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) assessing symptom burden and lifestyle behaviors; 2) generating and analyzing a symptom burden and lifestyle report; 3) engaging in empowerment-based therapeutic person-centered health communication; and 4) making a behavior commitment. Phase 2 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) integrating healthy behaviors into a long-term lifestyle; and 2) sustaining healthy lifestyle behaviors. 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. The control group will continue with their normal daily lifestyle. WeChat-based follow-ups will be conducted weekly during the first 4 weeks and biweekly in the subsequent 8 weeks, with each follow-up lasting 20 minutes. Follow-up communications will 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 through face-to-face interviews at the CHCCs, lasting about 30 minutes. 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: It involves an individualized face-to-face meeting conducted by the researcher in a private meeting room at the CHCCs within one week after random allocation, lasting about 1 hour. This phase includes four core steps: 1) assessing symptom burden and lifestyle behaviors; 2) generating and analyzing a symptom burden and lifestyle report; 3) engaging in empowerment-based therapeutic person-centered health communication; and 4) making a behavior commitment. Phase 2 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) integrating healthy behaviors into a long-term lifestyle; and 2) sustaining healthy lifestyle behaviors. 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 and 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. The control group will continue with their normal daily lifestyle. WeChat-based follow-ups will be conducted weekly during the first 4 weeks and biweekly in the subsequent 8 weeks, with each follow-up lasting 20 minutes. Follow-up communications will include: general well-being assessments; disease management monitoring; and addressing disease-related inquiries. 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

Interventions

Type	Name	Description
BEHAVIORAL	HcELP_CMM	The intervention consists of two phases. Phase 1 is an initial individualized, face-to-face meeting to collaboratively set goals and develop action plan (week 1) and Phase 2 is an ongoing, personalized online support 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) assess symptom burden and lifestyle behaviors; 2) generate and analysis symptom burden and lifestyle report; 3) empowerment-based therapeutic person-centered health communication; and 4) behavior commitment. Phase 2 covers two modules: 1) integrate healthy behaviors to long-term lifestyle, and 2) sustain healthy lifestyle behaviors.
BEHAVIORAL	Usual care-maintain daily lifestyle	Participants in this group will continue with their normal daily lifestyle. WeChat-based follow-up will be performed weekly in the first 4 weeks and bi-weekly in the next 8 weeks. Each follow-up will last for 20 minutes. Follow-up communications will include: (1) general well-being assessments using brief, non-intrusive inquiries (e.g., "How have participants felt overall in the past week/two weeks?"); (2) disease management monitoring through standardized question tracking significant changes in their underlying diseases, intentionally avoiding exploration of intervention-targeted lifestyle behaviors (e.g., "Have participants experienced notable changes in their health status or disease management approach since last contact?"); and (3) addressing disease-related inquiries. For any questions inquired by participants in the control group, general advice will be given for ethical consideration.

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-02-05
• Completion: 2027-02-05
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

3 sites across 1 country: China