NCT03332810

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

October 29, 2017

Last Update Submit

January 21, 2019

Conditions

Keywords

Mental healthMental well-beingCommunity-based engagementPositive psychologyPublic health approach

Outcome Measures

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.

    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

    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

    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

    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

    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

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

  • +6 more secondary outcomes

Study Arms (2)

SME family based physical activity

EXPERIMENTAL

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

Behavioral: SME family based physical activity

Gathering activity

ACTIVE COMPARATOR

Adults and family members will participate into two gathering activities

Behavioral: Gathering activity

Interventions

* 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.

SME family based physical 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.

Gathering activity

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Council of Social Service

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Man Ping Wang

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, School of Nursing

Study Record Dates

First Submitted

October 29, 2017

First Posted

November 6, 2017

Study Start

October 1, 2017

Primary Completion

June 30, 2018

Study Completion

November 30, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations