Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity

NCT07158697 | Recruiting

• 1 other identifier: UW 25-383
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this study is to:

1. 1.assess the feasibility, acceptability, and the preliminary effects of the health chat for empowerment-based lifestyle planning for CMM (HcELP\_CMM);
2. 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. 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 and acceptable?
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 (13)

• 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.

• 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.

Secondary Outcomes (25)

• Lifestyle behaviors

  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

  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

  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

  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

  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.

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) 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

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.

Behavioral: Usual Care

Interventions

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.

Usual care

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.

HcELP_CMM

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), which was defined as co-existing with two or more cardiometabolic diseases, including primary hypertension, type 2 diabetes, stroke, heart diseases (eg. coronary heart disease, arrhythmia, heart failure, myocardial infarction, and cardiac valve diseases), dyslipidemia, and obesity;
• 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.

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: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)