Lifestyle Hub Pilot Study (NCT04295369) | Clinical Trial Compass
UnknownNot Applicable
Lifestyle Hub Pilot Study
Hong Kong30 participantsStarted 2020-02-10
Plain-language summary
This study will examine the effects of a smartphone-based lifestyle medicine (LM) for improving psychological well-being in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of common mental disorders (e.g., depression and anxiety), modifying different lifestyle factors simultaneously may be effective to improve our psychological well-being. Chinese dietary recommendations will be integrated into the app to increase the acceptability towards mental health intervention. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for improving psychological well-being.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hong Kong residents
* Aged ≥ 18 years
* Able to read Chinese and type in Chinese or English
* Have an Internet-enabled mobile device (iOS or Android operating system)
* Are willing to provide informed consent and comply with the trial protocol
Exclusion Criteria:
* Have a Patient Health Questionnaire (PHQ-9) score ≥ 10
* Have a Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
* Current involvement in psychotherapy or unstable medication for depression and/or anxiety
* Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk)
* Are having unsafe conditions and are not recommended for physical activity or a change in diet by physicians
* Having major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Depression Anxiety Stress Scales-21
Timeframe: Immediately post-treatment and 1-month post treatment