Lifestyle Hub Pilot Study

March 3, 2020 updated by: Fiona YY Ho, Chinese University of Hong Kong

Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Improving Psychological Well-being: A Pilot Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Sha Tin, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lifestyle Medicine Group
Behavioral: Lifestyle Medicine
Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep, stress management, and Chinese dietary recommendations.
NO_INTERVENTION: Waitlist Control Group
Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Depression Anxiety Stress Scales-21
Time Frame: Immediately post-treatment and 1-month post treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-developed survey
Time Frame: Baseline
The self-developed survey will collect information including demographic information (e.g., age, gender, level of education, working industry, relationship status, and location of residence), substance use, body mass index (BMI), rest-activity pattern, and social rhythms, etc.
Baseline
Change in The Insomnia Severity Index (ISI)
Time Frame: Baseline, immediately post-treatment and 1-month post treatment
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5 point Likert scale are obtained on the perceived severity of sleep-onset, sleep maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Baseline, immediately post-treatment and 1-month post treatment
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Time Frame: Baseline, immediately post-treatment and 1-month post treatment
SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
Baseline, immediately post-treatment and 1-month post treatment
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Time Frame: Baseline, immediately post-treatment and 1-month post treatment
The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
Baseline, immediately post-treatment and 1-month post treatment
Change in the Sheehan Disability Scale (SDS)
Time Frame: Baseline, immediately post-treatment and 1-month post treatment
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. The participant rates the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 10 point visual analog scale. The numerical ratings of 0-10 can be translated into a percentage, if desired. The 3 items can also be summed into a single dimensional measure of global functional impairment that rages from 0 (unimpaired) to 30 (highly impaired).
Baseline, immediately post-treatment and 1-month post treatment
Change in the Credibility-Expectancy Questionnaire (CEQ)
Time Frame: Baseline, immediately post-treatment and 1-month post treatment
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Baseline, immediately post-treatment and 1-month post treatment
Change in the Food Frequency Questionnaires (FFQs)
Time Frame: Baseline, immediately post-treatment and 1-month post treatment
FFQs is a 18-item scale, including drinks, plant, animal products and cigarette intake, which measures the frequency of food intake over the past three months on a 7-point scale.
Baseline, immediately post-treatment and 1-month post treatment
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Time Frame: Baseline, immediately post-treatment and 1-month post treatment
Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from a short form of the International Physical Activity Questionnaire - Chinese version.
Baseline, immediately post-treatment and 1-month post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2020

Primary Completion (ANTICIPATED)

May 1, 2020

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

February 28, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (ACTUAL)

March 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSY010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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