Mental Well-beingNCT03332810
Healthy Community Pilot Project RCT Study
A study testing SME family based physical activity and Gathering activity in people with Mental Well-being and Happiness, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Aims: To enhance mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community. Targets: Adults aged 18-59 and their family members in Hong Kong. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Well-being, Happiness
- What is being tested?
- SME family based physical activity and Gathering activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Families (Major subjects):
- Adults aged 18-59 and their family members (Their family members could be children)
- Chinese speaking
- Able to complete study questionnaires/ focus groups
- Service providers of NGO service units
- Staff working in the participating NGO service units
Show all 13Show fewer
- Adults aged 18-59
- Chinese speaking
- Able to complete study questionnaires/ focus group
- Community partners
- Staff working in the collaborating NGO service units or District Healthy City Committees in partnership with HKU research team to organize or plan or implement the project
- Chinese speaking
- Able to complete study questionnaires/ individual in-depth interviews
Who cannot join
- Those who cannot read Chinese
- Those who suffered from severe mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-based Mental Wellness Project for Adolescents and Adults: Healthy Community Pilot Project RCT Study
Aims: To enhance mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community.
Targets: Adults aged 18-59 and their family members in Hong Kong.
Read more
Methods: Healthy Community Pilot Project will adopt the public health and family-focused approach, under the brand name of "Joyful@HK Campaign". Evidence-based and Evidence Generating approach with vigorous study design, both qualitative (e.g. focus groups) and quantitative (e.g. randomised controlled trial), will be used to evaluate the overall programme effectiveness including follow-up of at least one month ("best science"). To ensure the practicability and sustainability of the community-based engagement project, we will engage community partners with strong track records of "best practice" to design, plan, and implement the intervention. This project will use innovative and integrated positive psychology and public health theories and methods to plan brief, simple, and cost-effective intervention.
Significance: By using "best science" in the design and evaluation of intervention programme, and the "best practice" of the partners' skills, experience and strong connection with service targets in the community, the intervention, if proven to be effective, for promoting sharing, mind and enjoyment and enhancing mental well-being can be further developed and widely disseminated to and adopted by the practitioners in the health and social service sectors for replication and improvement to benefit the whole population.
Read the detailed description
Healthy Community Pilot Project is one of the six Community-based Mental Wellness Project for Adolescents and Adults, which aims at enhancing mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community. The project is funded by Health Care and Promotion Fund of Food and Health Bureau.
Healthy Community Pilot Project is organized by the Hong Kong Council of Social Service and led by the School of Public Health, The University of Hong Kong.The project will organize one train-the-trainer workshop to train the service providers from 8-10 NGO service units on the concept of sharing, mind and enjoyment (SME), ways of conducting SME family-based physical activities and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder). Two SME family-based physical activities will be held by the NGO service providers in collaboration with 3 District Healthy City Committees. Each NGO service unit may organize enjoyable SME family-based physical activities according to the needs of individual district and to promote positive psychology under the theme of Sharing, Mind and Enjoyment. One wisdom sharing session will be organized to members of District Healthy City Committees to promote best practice of community mental wellness project.
The major subjects of the Healthy Community Pilot Project RCT study are 150-200 families with 400 participants. 3 District Healthy City Committees will be selected as collaborators. 10-18 NGO service units will either be randomized into intervention service units and control service units. Cluster Randomized Control Trial will be used to evaluate the effectiveness of the intervention programme.
In the study, families will be invited to complete a series of questionnaires or invited to attend focus groups to measure the sharing, mind and enjoyment related behavioural changes, mental well-being and subjective changes. NGO workers who joined the train-the-trainer workshop will also be invited to complete questionnaires to measure their knowledge about mental health, skills of conducting SME family-based physical activities and their sharing, mind and enjoyment related behavioural change. They will be invited to focus group interview to assess their experience and feedback on this project while community partners will be invited to individual in-depth interviews to assess the outcomes of community engagement process.
HKU team will conduct evaluation during the programme implementation stage. The effectiveness of the intervention, as well as the level of participation and ratings for the intervention will also be evaluated.
- Conditions
- Mental Well-being, Happiness
- Being tested
- SME family based physical activity, Gathering activity
- Keywords
- Mental health, Mental well-being, Community-based engagement, Positive psychology, Public health approach
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SME family based physical activityBehavioural
- One train-the-trainer workshop: to train the service providers from 8-15 NGO service units on the concept of SME, ways of conducting mental well-being activities and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder).
- Two SME family-based physical activities held by each NGO service unit: to organize enjoyable activities according to the needs of individual district as well as to promote positive psychology under the theme of SME. All these activities are organized by the NGO service providers in collaboration with District Healthy City Committee.
Gathering activityBehavioural
- Gathering activities will be held for control groups. However, SME concept or techniques will not be introduced during the activity. Physical activity will not be used as the intervention method.
| Study group | Role | What they receive |
|---|---|---|
| SME family based physical activity | Experimental | Adults and family members will participate into one core session and one booster session Receives: Behavioral: SME family based physical activity |
| Gathering activity | Active comparator | Adults and family members will participate into two gathering activities Receives: Behavioral: Gathering activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours
The frequency of performing the SME (Sharing: encourage families to do physical activity, encourage families to do zero-time exercise, do physical activity with families; Mind: have intention, goal and confidence to do physical activity; Enjoyment: enjoy physical activity) related behaviours in the past 7 days will be assessed. The questions are rated 0-7 with 0 indicating none of this behavior happened in the past 7 days and 7 indicating this behavior happened every day in the past 7 days.
Measured: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Secondary outcomes (11)
Changes in personal happiness from baseline to three-month after baseline
Personal happiness will be assessed by Subjective Happiness Scale (SHS). SHS was rated on 7-point scale with 1 indicating not happiness at all and 7 indicating extreme happiness. To score the scale, the 4th item will be coded reversely and mean of the 4 items will be computed.
Measured: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in mental well-being from baseline to three-month after baseline
Mental well-being will be assessed by validated Chinese version of 7-item Warwick Edinburgh Well-being Scale. Each item ranges from 1 to 5 and the scale will be scored by first summing the score for each of the 7 items and then transforming the total score for each person according to a conversion table.
Measured: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in family relationship from baseline to three-month after baseline
Self-perceived understanding, intimacy, and family communication will be assessed by three questions (rated 0-10).
Measured: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in individual and family health from baseline to three-month after baseline
Self-perceived health, at the individual and family level will be assessed by two questions respectively (rated 0-10).
Measured: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in individual and family happiness from baseline to three-month after baseline
Self-perceived happiness, at the individual and family level will be assessed by two questions respectively (rated 0-10).
Measured: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in family harmony from baseline to three-month after baseline
Self-perceived family harmony will be assessed by a single question (rated 0-10).
Measured: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in knowledge and perception of mixed anxiety and depressive disorders
Knowledge and perception of mixed anxiety and depressive disorders will be assessed by 4 questions (2 questions about understanding of symptoms, 1 about the intention of help seeking, 1 about support seeking from families) rated 0-10.
Measured: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Satisfaction towards SME physical activity training & program
Satisfaction towards programme will be assessed by conducting focus group and program evaluation measures (general satisfaction, self-perceived helpfulness and likely-to-recommend level) rated 0-10.
Measured: T2: immediate post intervention; T3: one-month follow-up after baseline
The social impact of the community-based engagement project
The social impact of the community-based engagement project will be evaluated by conducting community stakeholders' in-depth interviews.
Measured: Up to four months
The process of community based intervention programme
Assessed by a Process Evaluation on-site observation form, and a series of checklists including Resources input record sheet, Participants' attendance form, Programme rundown, Attendance record form, and NGOs' final report. The components of process evaluation, including context, reach, dose delivered, dose received, fidelity and recruitment will be assessed.
Measured: Up to four months
Outcomes of community engagement process
Outcomes of community engagement process will be assessed by a self-designed questionnaire survey.
Measured: Up to four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Oct 2017
- Primary completion30 Jun 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Well-beingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Council of Social Service
- Responsible party
- Principal investigator, Dr. Wang Man-Ping, The University of Hong Kong
- Investigators
- Man Ping Wang, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332810
- Sponsor's protocol ID
- SPH-MHP-HKCSS01
- Status last verified
- Jan 2019
- First submitted
- 29 Oct 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun Y, Ho SY, Chan CS, Wang MP, Wan ANT, Xu Y, Lai AYK, Lam TH. Brief Intervention to Promote Physical Activity and Mental Well-Being in Community Adults: A Pilot Cluster Randomized Controlled Trial. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241281567. doi: 10.1177/21501319241281567.
PubMed 39279371
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Mental Wellness Project for Adolescents and Adults: Healthy Community Pilot Project RCT Study
- ClinicalTrials.gov ID
- NCT03332810
- Acronym / sponsor ID
- SPH-MHP-HKCSS01
- Conditions
- Mental Well-being, Happiness
- Keywords
- Mental health, Mental well-being, Community-based engagement, Positive psychology, Public health approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Council of Social Service
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims: To enhance mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community.
Targets: Adults aged 18-59 and their family members in Hong Kong.
Methods: Healthy Community Pilot Project will adopt the public health and family-focused approach, under the brand name of "Joyful@HK Campaign". Evidence-based and Evidence Generating approach with vigorous study design, both qualitative (e.g. focus groups) and quantitative (e.g. randomised controlled trial), will be used to evaluate the overall programme effectiveness including follow-up of at least one month ("best science"). To ensure the practicability and sustainability of the community-based engagement project, we will engage community partners with strong track records of "best practice" to design, plan, and implement the intervention. This project will use innovative and integrated positive psychology and public health theories and methods to plan brief, simple, and cost-effective intervention.
Significance: By using "best science" in the design and evaluation of intervention programme, and the "best practice" of the partners' skills, experience and strong connection with service targets in the community, the intervention, if proven to be effective, for promoting sharing, mind and enjoyment and enhancing mental well-being can be further developed and widely disseminated to and adopted by the practitioners in the health and social service sectors for replication and improvement to benefit the whole population.
Detailed description
Healthy Community Pilot Project is one of the six Community-based Mental Wellness Project for Adolescents and Adults, which aims at enhancing mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community. The project is funded by Health Care and Promotion Fund of Food and Health Bureau.
Healthy Community Pilot Project is organized by the Hong Kong Council of Social Service and led by the School of Public Health, The University of Hong Kong.The project will organize one train-the-trainer workshop to train the service providers from 8-10 NGO service units on the concept of sharing, mind and enjoyment (SME), ways of conducting SME family-based physical activities and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder). Two SME family-based physical activities will be held by the NGO service providers in collaboration with 3 District Healthy City Committees. Each NGO service unit may organize enjoyable SME family-based physical activities according to the needs of individual district and to promote positive psychology under the theme of Sharing, Mind and Enjoyment. One wisdom sharing session will be organized to members of District Healthy City Committees to promote best practice of community mental wellness project.
The major subjects of the Healthy Community Pilot Project RCT study are 150-200 families with 400 participants. 3 District Healthy City Committees will be selected as collaborators. 10-18 NGO service units will either be randomized into intervention service units and control service units. Cluster Randomized Control Trial will be used to evaluate the effectiveness of the intervention programme.
In the study, families will be invited to complete a series of questionnaires or invited to attend focus groups to measure the sharing, mind and enjoyment related behavioural changes, mental well-being and subjective changes. NGO workers who joined the train-the-trainer workshop will also be invited to complete questionnaires to measure their knowledge about mental health, skills of conducting SME family-based physical activities and their sharing, mind and enjoyment related behavioural change. They will be invited to focus group interview to assess their experience and feedback on this project while community partners will be invited to individual in-depth interviews to assess the outcomes of community engagement process.
HKU team will conduct evaluation during the programme implementation stage. The effectiveness of the intervention, as well as the level of participation and ratings for the intervention will also be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SME family based physical activity | Experimental | Behavioral: SME family based physical activityAdults and family members will participate into one core session and one booster session |
| Gathering activity | Active comparator | Behavioral: Gathering activityAdults and family members will participate into two gathering activities |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Families (Major subjects):
- Service providers of NGO service units
- Community partners
Key exclusion criteria (2 listed)
- Those who cannot read Chinese
- Those who suffered from severe mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SME family based physical activity* One train-the-trainer workshop: to train the service providers from 8-15 NGO service units on the concept of SME, ways of conducting mental well-being activities and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder). * Two SME family-based physical activities held by each NGO service unit: to organize enjoyable activities according to the needs of individual district as well as to promote positive psychology under the theme of SME. All these activities are organized by the NGO service providers in collaboration with District Healthy City Committee. | Behavioural | SME family based physical activity |
| Gathering activity- Gathering activities will be held for control groups. However, SME concept or techniques will not be introduced during the activity. Physical activity will not be used as the intervention method. | Behavioural | Gathering activity |
Primary outcome
Changes in participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours
Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
The frequency of performing the SME (Sharing: encourage families to do physical activity, encourage families to do zero-time exercise, do physical activity with families; Mind: have intention, goal and confidence to do physical activity; Enjoyment: enjoy physical activity) related behaviours in the past 7 days will be assessed. The questions are rated 0-7 with 0 indicating none of this behavior happened in the past 7 days and 7 indicating this behavior happened every day in the past 7 days.
11 secondary outcomes
Changes in personal happiness from baseline to three-month after baseline
Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in mental well-being from baseline to three-month after baseline
Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in family relationship from baseline to three-month after baseline
Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in individual and family health from baseline to three-month after baseline
Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in individual and family happiness from baseline to three-month after baseline
Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in family harmony from baseline to three-month after baseline
Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Changes in knowledge and perception of mixed anxiety and depressive disorders
Time frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Satisfaction towards SME physical activity training & program
Time frame: T2: immediate post intervention; T3: one-month follow-up after baseline
The social impact of the community-based engagement project
Time frame: Up to four months
The process of community based intervention programme
Time frame: Up to four months
Outcomes of community engagement process
Time frame: Up to four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Derived from this study: PubMed 39279371Sun Y, Ho SY, Chan CS, Wang MP, Wan ANT, Xu Y, Lai AYK, Lam TH. Brief Intervention to Promote Physical Activity and Mental Well-Being in Community Adults: A Pilot Cluster Randomized Controlled Trial. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241281567. doi: 10.1177/21501319241281567.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Man Ping Wang principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SME family based physical activity and Gathering activity in people with Mental Well-being and Happiness, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours (time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03332810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.