Lifestyle Hub Pilot Study
Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Improving Psychological Well-being: A Pilot Randomized Controlled Trial
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2020
CompletedFirst Submitted
Initial submission to the registry
February 28, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMarch 4, 2020
March 1, 2020
3 months
February 28, 2020
March 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Depression Anxiety Stress Scales-21
DASS-21 is a 21-items scale, comprises of three sub-scales which measures the negative emotional states of depression, anxiety, and stress, over the past week. The DASS is based on a dimensional rather than a categorical conception of psychological disorder, thus it has no direct implications for the allocation of patients to discrete diagnostic categories. However, recommended cutoff scores for conventional severity labels (normal, moderate, severe) are given in the DASS Manual.
Immediately post-treatment and 1-month post treatment
Secondary Outcomes (8)
Change in The Insomnia Severity Index (ISI)
Baseline, immediately post-treatment and 1-month post treatment
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Baseline, immediately post-treatment and 1-month post treatment
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Baseline, immediately post-treatment and 1-month post treatment
Change in the Sheehan Disability Scale (SDS)
Baseline, immediately post-treatment and 1-month post treatment
Change in the Credibility-Expectancy Questionnaire (CEQ)
Baseline, immediately post-treatment and 1-month post treatment
- +3 more secondary outcomes
Study Arms (2)
Lifestyle Medicine Group
EXPERIMENTALWaitlist Control Group
NO INTERVENTIONParticipants in the waitlist control group will receive the intervention after the immediate post-treatment assessment.
Interventions
Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep, stress management, and Chinese dietary recommendations.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Chinese University of Hong Kong
Shatin, Hong Kong
Related Publications (1)
Wong VW, Tong JT, Shi NK, Ng CH, Sarris J, Ho FY. Smartphone-delivered multicomponent lifestyle medicine intervention for improving mental health in a nonclinical population: a randomized controlled trial. Front Public Health. 2024 Jan 16;11:1231981. doi: 10.3389/fpubh.2023.1231981. eCollection 2023.
PMID: 38292386DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 28, 2020
First Posted
March 4, 2020
Study Start
February 10, 2020
Primary Completion
May 1, 2020
Study Completion
June 1, 2020
Last Updated
March 4, 2020
Record last verified: 2020-03