Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
HcELP_CMM
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
232 Participants
are divided into 2 treatment groupsGroup A: HcELP_CMMExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Eligibility rate
Eligibility rate will only be measured in the pilot part，which will be calculated as eligible participants divided by screened participants.
Time frame
Eligibility rate will be assessed at baseline only in the pilot part.2
Recruitment rate
Recruitment rate will only be measured in the pilot part, which will be calculated as randomized participants divided by eligible participants.
Time frame
Recruitment rate will be assessed at baseline only in the pilot part.3
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.
Time frame
Adherence rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.4
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.
Time frame
Reasons for refusal to participate the program will be assessed at baseline only in the pilot part.Secondary 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.
Time frame
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.2
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.
Time frame
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.3
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).
Time frame
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
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.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov