ClinicalTrials.gg
CompletedNCT03332810Updated Jan 23, 2019

Healthy Community Pilot Project RCT Study

An interventional study of SME family based physical activity and Gathering activity in Mental Well-being and Happiness, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-23.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention

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Phase
Not applicable
Study type
Interventional
Enrollment
342
Allocation
Randomized
Ages
6 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 20 studies in Psychological Well-Being by The University of Hong Kong — 9 open to participants now, 9 under way, none of them phase 3. Psychological Well-Being · The University of Hong Kong.

Enrollment
3rd of 18
342 · median 139
Started
2017
with 4 others
No phase
17 of 20
9 open now
Registered
5th of 20
by date

Among the 20 studies in Psychological Well-Being by The University of Hong Kong, this one is the 3rd largest by enrollment of the 18 interventional ones that give a count, is one of 5 that started in 2017, is one of 17 with no phase, and was the 5th registered.

Psychological Well-Being

2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.

Browse Psychological Well-Being studies →

Open to participants now

9 of the 20 studies in Psychological Well-Being by The University of Hong Kong are open now, in 1 country. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 9 open studies →

Where they have run

Who these studies take

Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.

This study: 6 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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.

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.

03

Conditions studied

  • Mental Well-being
  • Happiness

Keywords

  • Mental health
  • Mental well-being
  • Community-based engagement
  • Positive psychology
  • Public health approach
04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. Service providers of NGO service units

    • Staff working in the participating NGO service units
    • Adults aged 18-59
    • Chinese speaking
    • Able to complete study questionnaires/ focus group
  3. 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

Exclusion criteria

Exclusion Criteria:

  • Those who cannot read Chinese
  • Those who suffered from severe mental disorders
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
342 participants (actual)

Study arms

  • Experimental
    SME family based physical activity

    Adults and family members will participate into one core session and one booster session

    Behavioral: SME family based physical activity

  • Active comparator
    Gathering activity

    Adults and family members will participate into two gathering activities

    Behavioral: Gathering activity

Interventions

  • BehavioralSME 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.

  • BehavioralGathering 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline

Secondary outcomes

  1. 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.

    Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline

  2. 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.

    Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline

  3. 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).

    Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline

  4. 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).

    Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline

  5. 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).

    Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline

  6. 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).

    Time frame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline

  7. 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.

    Time frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline

  8. 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.

    Time frame: T2: immediate post intervention; T3: one-month follow-up after baseline

  9. 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.

    Time frame: Up to four months

  10. 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.

    Time frame: Up to four months

  11. Outcomes of community engagement process

    Outcomes of community engagement process will be assessed by a self-designed questionnaire survey.

    Time frame: Up to four months

07

Study locations

1 site
  • The Hong Kong Council of Social Service
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jun 2018, 8 months.

Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's 8 months is below that.

Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2017
First posted
Nov 6, 2017
StartActual
Oct 1, 2017
Primary completionActual
Jun 30, 2018
CompletionActual
Nov 30, 2018
Last update
Jan 23, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03332810
Collaborators
The Hong Kong Council of Social Service
Responsible party
Dr. Wang Man-Ping (Assistant Professor, School of Nursing, The University of Hong Kong) — Principal investigator
First posted
Nov 6, 2017
Start date
Oct 1, 2017
Primary completion
Jun 30, 2018
Completion
Nov 30, 2018
Last update
Jan 23, 2019

Study contacts

Man Ping Wang
principal investigator · The University of Hong Kong

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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