Lifestyle Hub Pilot Study

NCT ID: NCT04295369

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will be a randomized controlled trial on the effects of a culturally adapted self-help smartphone-based lifestyle medicine for improving psychological well-being in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 30 eligible participants will be randomly assigned to either smartphone-based lifestyle medicine (LM group) or the waitlist control group (WL group) in a ratio of 1:1.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychological Distress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lifestyle Medicine Group

Group Type EXPERIMENTAL

Lifestyle Medicine

Intervention Type BEHAVIORAL

Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep, stress management, and Chinese dietary recommendations.

Waitlist Control Group

Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lifestyle Medicine

Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep, stress management, and Chinese dietary recommendations.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fiona YY Ho

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vincent Wong

Role: CONTACT

+852 3943 6575

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fiona Ho

Role: primary

+852 39436575

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38292386 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PSY010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Game Intervention for Resilience
NCT07235696 RECRUITING NA