Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity

NCT07158697 | Recruiting

• 1 other identifier: UW 25-383
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this study is to:

1. 1.assess the feasibility of the health chat for empowerment-based lifestyle planning for cardiometabolic multimorbidity (HcELP\_CMM);
2. 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. 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.
4. 4.If the HcELP\_CMM program is feasible?
5. 5.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？
6. 6.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？

Conditions

Cardiometabolic Diseases; Multimorbidity

Keywords

Cardiometabolic multimorbidity; Empowerment; Patient-centered; Self-management; Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (30)

• Eligibility rate

  Eligibility rate will be assessed at baseline only in the pilot part.

• Recruitment rate

  Recruitment rate will be assessed at baseline only in the pilot part.

• Attendance rate

  Attendance rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.

• Adherence rate

  Adherence rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.

• Attrition rate

  Attrition rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.

Study Arms (2)

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) an initial individualized, face-to-face meeting to collaboratively set goals and develop action plan (week 1); 2) 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: HcELP_CMM

Usual care-maintain daily lifestyle

PLACEBO COMPARATOR

Participants in the arm 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.

Behavioral: Usual care-maintain daily lifestyle

Interventions

HcELP_CMM BEHAVIORAL

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.

HcELP_CMM

Usual care-maintain daily lifestyle BEHAVIORAL

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.

Usual care-maintain daily lifestyle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or above；
• Diagnosed with cardiometabolic multimorbidity (CMM) by doctors, which was defined as co-existing with two or more cardiometabolic diseases, including primary hypertension, primary type 2 diabetes, stroke, and heart diseases (eg. ischemic heart disease, arrhythmia, heart valve diseases, and other heart diseases);
• Possessed a digital device installed with WeChat, as well as with an internet connection.

You may not qualify if:

• 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;
• Unable to sign the informed consent form.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (3)

Gusu District Feng Men Street Community Health Service Center

Suzhou, Jiangsu, 215000, China

RECRUITING

Gusu District Jinchang Street Bailian Community Health Service Center

Suzhou, Jiangsu, 215000, China

RECRUITING

Gusu District Shuang Ta Street Jinfan Community Health Service Center

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Jing Xi, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Xi, PhD

CONTACT

0086-15850061924; u3010484@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 8, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)