mHealth-supported Coach
- Conditions
- Heart Disease Risk Factors
- Interventions
- Behavioral: mHealth-supported coachingBehavioral: Conventional Health coaching
- Registration Number
- NCT05422729
- Lead Sponsor
- Food and Health Bureau, Hong Kong
- Brief Summary
A randomised controlled trial to evaluate the effects of a personalised mHealth-supported coach programme in the middle-aged group with stroke risk.
- Detailed Description
Aim: To evaluate the effects of a personalised mHealth-supported coach programme on the adoption of health-promoting behaviours in the middle-aged group, in comparison with usual care.
Design: A 24-month prospective two-arm, parallel-group, single-blinded, repeated-measure randomised controlled trial will be conducted.
Participants: People who aged between 40 and 64, mentally competent, have a non-laboratory INTERHEART risk score (IHRS) of 10 or higher, communicable in Chinese and free from stroke and transient ischemic attack (TIA) or other cardiovascular disease will be eligible to the study. A total of 164 participants will be recruited through a district community centre and randomly assigned on 1:1 ratio to the intervention group or the control group.
Intervention: A theory-based mHealth-supported coach programme, including individual consultation sessions and a mobile application with a virtual sharing platform, is developed by a multidisciplinary team for the intervention group over three months, whereas the control group receives usual care.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 164
- Chinese ethnic
- able to read Chinese and communicate in Cantonese/Mandarin
- with non-laboratory IHRS score 10 or higher
- mentally incompetent
- previously diagnosed with stroke, TIA, MI, coronary heart disease, heart failure or atrial fibrillation
- with eye or retinal disease
- with terminal disease with an expected life expectancy less than six months
- being pregnant
- have enrolled in other lifestyle-based or exercise-based projects
- do have mobile devices or internet service to access the mobile application
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Personalised mHeatlh-supported coaching programme mHealth-supported coaching Three monthly individual consultation session, supported with a specific mobile application. Traditional in-person health coaching programme Conventional Health coaching Three monthly individual consultation sessions.
- Primary Outcome Measures
Name Time Method Health-promoting behaviours 6-month post-allocation Four subscales, including health responsibility, nutrition, physical activity and stress management, of the Health Promoting Lifestyle Profile II. The possible score range from 34 to 136, with a higher score meaning healthier lifestyles were adopted.
- Secondary Outcome Measures
Name Time Method Self-efficacy of adopting health-promoting behaviours 3-month post-allocation The adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used. Participants will rate their level of confidence in various behaviours, in diet control, weight control and lifestyle management, by using a five-point Likert scale. The possible scores ranged from 7 to 35, with a higher score meaning a higher level of self-efficacy.
Change in Body mass index (BMI) Between baseline and 3-month post-allocation BMI will be calculated by dividing the weight (in kilogram) by the height (in meter) squared. The height will be measured using a stadiometer, and body weight will be measured using an electronic scale.
Change in Blood lipid profile Between 3-month and 6-month post-allocation The profile includes ncluding triglyceride, total Cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C). Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
INTERHEART risk score 6-month post-allocation The score was calculated based on the weighted sum of nine risk factors, including age, sex, lifestyles and psychosocial wellbeing, which were significantly related to cardiovasuclar diseases. The possible score range was 0 - 48, in which a higher score corresponds to higher risk.
Change in Waist-hip ratio (WHR) Between 3-month and 6-month post-allocation WHR will be used for determining body fat distribution. Waist circumference will be measured at the mid-point between the lowest rib and the iliac crest, whereas hip circumference will be measured at the widest level over the great trochanters. The two measurements will be measured to the nearest 0.1 cm by using a measuring tape.
Change in Fasting blood glucose Between 3-month and 6-month post-allocation Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.
Self-efficacy 6-month post-allocation The adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used. Participants will rate their level of confidence in various behaviours, in diet control, weight control and lifestyle management, by using a five-point Likert scale. The possible scores ranged from 7 to 35, with a higher score meaning a higher level of self-efficacy.
automatic retinal image analysis (ARIA) 6-month post-allocation Retinal fundus image will be obtained from both eyes of the participant using a non-mydriatic digital retinal camera (Canon CR-2 AF, U.S.A., Inc). Stroke risk estimation will be determined through fractural analysis, statistical texture analysis and high-order spectra analysis based on the retinal vessel parameters. The ARIA-stroke algorithm developed using R and Matlab software has a sensitivity and a specificity of 94.7% and 100%, respectively. The value between 0.5 and 0.7 is considered as moderate risk, while high risk is considered at 0.7 or higher.
Change in Body mass index(BMI) Between 3-month and 6-month post-allocation BMI will be calculated by dividing the weight (in kilogram) by the height (in meter) squared. The height will be measured using a stadiometer, and body weight will be measured using an electronic scale.
automatic retinal image analysis 3-month post-allocation Retinal fundus image will be obtained from both eyes of the participant using a non-mydriatic digital retinal camera (Canon CR-2 AF, U.S.A., Inc). Stroke risk estimation will be determined through fractural analysis, statistical texture analysis and high-order spectra analysis based on the retinal vessel parameters. The ARIA-stroke algorithm developed using R and Matlab software has a sensitivity and a specificity of 94.7% and 100%, respectively. The value between 0.5 and 0.7 is considered as moderate risk, while high risk is considered at 0.7 or higher.
Change in Blood pressure Between 3-month and 6-month post-allocation Blood pressure measurement will be carried out, after 10 min of rest, on the left arm in a sitting posture by using an electronic sphygmomanometer.
Psychological distress 6-month post-allocation The Depression Anxiety Stress Scale (DASS-21)includes 21 items, with 7 in each subscale: depression, anxiety and stress. Participants will rate their level of agreement with the statements on a 4-point Likert scale, from 0 (not apply to me at all) to 3 (applied to me very much). The potential scores range from 0 to 63, with a higher score means higher level of distress experienced.
Trial Locations
- Locations (1)
The Chinese University of Hong Kong
šš°Hong Kong, Hong Kong