Clinical trial NCT05949320: "Health in Mobile" for Community-dwelling Individuals With Chronic Diseases
Official title: "Health in Mobile" - The e-Motivational-Interviewing Intervention for Community-dwelling Individuals With Chronic Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intervention
Control Group
Keywords: Motivational Interviewing
Hypertension
Diabetes Mellitus
Mobile Phone-Based Intervention
mHealth
Lead sponsor: Education University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Society for Rehabilitation
First posted: 2023-07-18
Enrollment: 1600
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to provide a mobile-apps-based intervention to facilitate individuals with chronic diseases such as high blood pressure and diabetes to adopt healthy behaviours. The intervention is based on Motivational Interviewing, a clinical technique used to enhance an individual's behavioural changes. The proposed research project comprises developing and validating the "Health in Mobile" app, which we call e-MI, which will then be launched to members of the three District Health Centre Express (DCHEs) who have presented with clinical/preclinical chronic health issues such as high blood pressure and diabetes. The participants are registered members of the three DCHEs. The targeted sample size is 1600 members, with 1200 are in the e-MI group while the other 400 are in the waiting list control group.

Detailed description: Motivational interviewing (MI) is a clinical technique used to enhance an individual's behavioral changes. The MI intervention shares a similar basis as the cognitive behavioral therapy based on the Stages of Change. It has been found effective for enabling individuals to tackle their problems in weight control, substance abuse, and smoking.

The proposed study focuses on facilitating individuals with chronic diseases such as high blood pressure and diabetes to adopt health behaviors. The technique employed to facilitate the behavioral changes is the MI. Previous literature has reported the positive effects of MI in patients with chronic diseases. For instance, promoting weight loss in overweight and obese individuals, improving physical activity self-management in adults with type II diabetes, and regulation in blood pressure level among hypertensive individuals. However, the applications of the MI are mostly via the face-to-face method. Other application methods such as telephone coaching, online synchronous chat and mobile app are delivered as the alternative for communication. Individuals are engaged to enhance or modify certain behaviors via such as instant text interaction with psychologists, messages generated from a predefined system, and messages from interactive tools based on one's situation. Positive intervention effects were observed in these alternative forms of MI in terms of successful weight loss from a mobile app and telephone coaching and smoking cessation from telephone coaching. However, drawbacks include decreased attendance and engagement for lengthy programs, technical issues in delivering messages, and over-simplification of materials. The purpose of this study, therefore, is to deliver the MI to the participants with the use of perceptual learning theories, and the differential focuses on the cognitive and affective components when viewing simple MI messages via an app, and we name it the e-MI.

Eligibility criteria: Inclusion Criteria:

* 1) pass the cognitive screening test indicating low risk of mild cognitive impairment and depressive moods;
* 2) age 45 to 75 years;
* 3) completed primary school education or above;
* 4) has a considerate level of information literacy access to mobile phones and tablets;
* 5) agree to participate in the study and provide informed consent.

Exclusion Criteria:

* 1) participants with type 1 diabetes, impaired glucose tolerance, metabolic syndrome, maturity-onset diabetes of youth, or gestational diabetes;
* 2) clinical diagnosis of cardiovascular disease, kidney disease, liver disease, malignant tumour, or new-onset diabetes after organ transplant;
* 3) participants with a psychiatric or neurological disability

Primary outcomes:
measure: The Chinese Affect Scale
timeFrame: Baseline
measure: The Chinese Affect Scale
timeFrame: 3 months
measure: The Chinese Affect Scale
timeFrame: 9 months
measure: The Chinese version of University of Rhode Island Change Assessment
timeFrame: Baseline
measure: The Chinese version of University of Rhode Island Change Assessment
timeFrame: 3 months
measure: The Chinese version of University of Rhode Island Change Assessment
timeFrame: 9 months
measure: The International Physical Activity Questionnaire - Short Form
timeFrame: Baseline
measure: The International Physical Activity Questionnaire - Short Form
timeFrame: 3 months
measure: The International Physical Activity Questionnaire - Short Form
timeFrame: 9 months
measure: The standard 12-Item Short Form Health Survey
timeFrame: Baseline
measure: The standard 12-Item Short Form Health Survey
timeFrame: 3 months
measure: The standard 12-Item Short Form Health Survey
timeFrame: 9 months
measure: The Treatment Self-Regulation Questionnaire
timeFrame: Baseline
measure: The Treatment Self-Regulation Questionnaire
timeFrame: 3 months
measure: The Treatment Self-Regulation Questionnaire
timeFrame: 9 months
measure: The Contemplation Ladder
timeFrame: Baseline
measure: The Contemplation Ladder
timeFrame: 3 months
measure: The Contemplation Ladder
timeFrame: 9 months
measure: The Chinese version of the 7-item Generalized Anxiety Disorder scale
timeFrame: Baseline
measure: The Chinese version of the 7-item Generalized Anxiety Disorder scale
timeFrame: 3 months
measure: The Chinese version of the 7-item Generalized Anxiety Disorder scale
timeFrame: 9 months
measure: Health Promotion Lifestyle Profile - II: Chinese version Short Form
timeFrame: Baseline
measure: Health Promotion Lifestyle Profile - II: Chinese version Short Form
timeFrame: 3 months
measure: Health Promotion Lifestyle Profile - II: Chinese version Short Form
timeFrame: 9 months
measure: Self-Reported Chronic Medical Conditions
timeFrame: Baseline
measure: Self-Reported Chronic Medical Conditions
timeFrame: 3 months
measure: Self-Reported Chronic Medical Conditions
timeFrame: 9 months
measure: The Chinese version of the Satisfaction with Life Scale
timeFrame: Baseline
measure: The Chinese version of the Satisfaction with Life Scale
timeFrame: 3 months
measure: The Chinese version of the Satisfaction with Life Scale
timeFrame: 9 months
measure: The Chinese version of the nine-item Patient Health Questionnaire
timeFrame: Baseline
measure: The Chinese version of the nine-item Patient Health Questionnaire
timeFrame: 3 months
measure: The Chinese version of the nine-item Patient Health Questionnaire
timeFrame: 9 months
measure: Eating Behaviour Questionnaire from the EatSmart Restaurant Star+ Campaign
timeFrame: Baseline
measure: Eating Behaviour Questionnaire from the EatSmart Restaurant Star+ Campaign
timeFrame: 3 months
measure: Eating Behaviour Questionnaire from the EatSmart Restaurant Star+ Campaign
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: North Point
country: Hong Kong
facility: Eastern District Health Centre Express
city: Sai Ying Pun
country: Hong Kong
facility: Central and Western District Health Centre Express
city: Sha Tin
country: Hong Kong
facility: Sha Tin District Health Centre Express
Study officials:
affiliation: The Education University of Hong Kong
name: Che Hin Chetwyn Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: