FamilyNCT04550065
A Digital Game on Promoting Family Well-being
A study testing Digital game in people with Family, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Advances in information communication technologies (ICT) allow for ICT-assisted health promotion to become more common. Integrating ICT in health promotion has been suggested to offer many advantages compared to traditional approaches to promote family well-being. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Family
- What is being tested?
- Digital game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2020to Dec 2022
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese-speaking;
- Individuals aged 18 years and above;
- Able to understand and play the game.
Who cannot join
- Individuals who cannot meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong community
Hong Kong, 852
Agnes YK Lai, PhD, 3917-6283, agneslai@hku.hk
Asa Choi, MA, 3917-6661, asachoi@hku.hk
About this study
Official title: SMART Family-Link Project: A Digital Game on Promoting Family Well-being
Advances in information communication technologies (ICT) allow for ICT-assisted health promotion to become more common. Integrating ICT in health promotion has been suggested to offer many advantages compared to traditional approaches to promote family well-being. Research has also shown the positive effects of game-based approaches in enhancing health promotion interventions, especially with children. We will develop and assess a digital family game with theme-based mini-games to enhance family communication and well-being.
Read the detailed description
With growing emphasis on the development and maintenance of healthy lifestyles, the family role has increasing importance. A family-based health promotion strategy can be instrumental in helping disseminate and reinforce knowledge and behaviours on family well-being and better equip families to protect themselves and promote family well-being amidst the pandemic.
This study aims to use a game-based approach to enhance knowledge and behaviours on family well-being. We will conduct quantitative and qualitative evaluation. The findings would provide preliminary evidence of the feasibility and effectiveness of such an approach in a family-based context. It would also guide the direction for future health education and awareness trials and related projects and campaigns for health promotion efforts and to help improve family well-being in the Hong Kong community and elsewhere.
- Conditions
- Family
- Being tested
- Digital game
- Keywords
- Family well-being, Family communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital gameBehavioural
A digital family game with theme-based mini games (epidemic prevention, exercise, diet, communication and parenting)
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Digital game Receives: Behavioral: Digital game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived improved family well-being
Change assessed by a validated one-item Family Happiness scale (score from 0 to 10, higher scores indicate more family happiness).
Measured: Baseline and one month
Secondary outcomes (4)
Perceived improved family communication
Change assessed by a one-item family communication scale (score from 0 to 10, higher scores indicate better family communication).
Measured: Baseline and one month
Perceived improved family health
Change assessed by a one-item family health scale (score from 0 to 10, higher scores indicate better family health).
Measured: Baseline and one month
Family well-being knowledge and behaviors
Change assessed by outcome-based questions (scores from 0 to 10, higher scores indicate better knowledge and behaviors)
Measured: Baseline and one month
Practice of sharing family well-being knowledge
Assessed by outcome-based questions with categorical choices
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Sep 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FamilyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong
- Investigators
- Agnes Y Lai, PhD, Principal investigator, School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550065
- Sponsor's protocol ID
- UW 20-353
- Status last verified
- Nov 2021
- First submitted
- 7 Sep 2020
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share after study finished
Publications
Ameryoun A, Sanaeinasab H, Saffari M, Koenig HG. Impact of Game-Based Health Promotion Programs on Body Mass Index in Overweight/Obese Children and Adolescents: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Child Obes. 2018 Feb/Mar;14(2):67-80. doi: 10.1089/chi.2017.0250. Epub 2017 Nov 29.
PubMed 29185787Chagas CMDS, Pontes E Silva TB, Reffatti LM, Botelho RBA, Toral N. Rango Cards, a digital game designed to promote a healthy diet: a randomized study protocol. BMC Public Health. 2018 Jul 24;18(1):910. doi: 10.1186/s12889-018-5848-0.
PubMed 30041639Edwards EA, Lumsden J, Rivas C, Steed L, Edwards LA, Thiyagarajan A, Sohanpal R, Caton H, Griffiths CJ, Munafo MR, Taylor S, Walton RT. Gamification for health promotion: systematic review of behaviour change techniques in smartphone apps. BMJ Open. 2016 Oct 4;6(10):e012447. doi: 10.1136/bmjopen-2016-012447.
PubMed 27707829Sit SM, Lai AY, Wong HW, Hung KS, Wang MP, Ho SY, Lam TH. Gamified Strength Recognition and Quiz to Enhance COVID-19 Prevention, Knowledge, Behaviors, and Family Well-Being. Games Health J. 2024 Jun;13(3):172-183. doi: 10.1089/g4h.2023.0190. Epub 2024 Mar 20.
PubMed 38512294
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Family-Link Project: A Digital Game on Promoting Family Well-being
- ClinicalTrials.gov ID
- NCT04550065
- Acronym / sponsor ID
- UW 20-353
- Conditions
- Family
- Keywords
- Family well-being, Family communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Sep 2020 (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.
Advances in information communication technologies (ICT) allow for ICT-assisted health promotion to become more common. Integrating ICT in health promotion has been suggested to offer many advantages compared to traditional approaches to promote family well-being. Research has also shown the positive effects of game-based approaches in enhancing health promotion interventions, especially with children. We will develop and assess a digital family game with theme-based mini-games to enhance family communication and well-being.
Detailed description
With growing emphasis on the development and maintenance of healthy lifestyles, the family role has increasing importance. A family-based health promotion strategy can be instrumental in helping disseminate and reinforce knowledge and behaviours on family well-being and better equip families to protect themselves and promote family well-being amidst the pandemic.
This study aims to use a game-based approach to enhance knowledge and behaviours on family well-being. We will conduct quantitative and qualitative evaluation. The findings would provide preliminary evidence of the feasibility and effectiveness of such an approach in a family-based context. It would also guide the direction for future health education and awareness trials and related projects and campaigns for health promotion efforts and to help improve family well-being in the Hong Kong community and elsewhere.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Digital gameDigital game |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese-speaking;
- Individuals aged 18 years and above;
- Able to understand and play the game.
Key exclusion criteria (1 listed)
- Individuals who cannot meet the inclusion criteria.
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 |
|---|---|---|
| Digital gameA digital family game with theme-based mini games (epidemic prevention, exercise, diet, communication and parenting) | Behavioural | Intervention arm |
Primary outcome
Perceived improved family well-being
Time frame: Baseline and one month
Change assessed by a validated one-item Family Happiness scale (score from 0 to 10, higher scores indicate more family happiness).
4 secondary outcomes
Perceived improved family communication
Time frame: Baseline and one month
Perceived improved family health
Time frame: Baseline and one month
Family well-being knowledge and behaviors
Time frame: Baseline and one month
Practice of sharing family well-being knowledge
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Background: PubMed 29185787Ameryoun A, Sanaeinasab H, Saffari M, Koenig HG. Impact of Game-Based Health Promotion Programs on Body Mass Index in Overweight/Obese Children and Adolescents: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Child Obes. 2018 Feb/Mar;14(2):67-80. doi: 10.1089/chi.2017.0250. Epub 2017 Nov 29.
- Background: PubMed 30041639Chagas CMDS, Pontes E Silva TB, Reffatti LM, Botelho RBA, Toral N. Rango Cards, a digital game designed to promote a healthy diet: a randomized study protocol. BMC Public Health. 2018 Jul 24;18(1):910. doi: 10.1186/s12889-018-5848-0.
- Background: PubMed 27707829Edwards EA, Lumsden J, Rivas C, Steed L, Edwards LA, Thiyagarajan A, Sohanpal R, Caton H, Griffiths CJ, Munafo MR, Taylor S, Walton RT. Gamification for health promotion: systematic review of behaviour change techniques in smartphone apps. BMJ Open. 2016 Oct 4;6(10):e012447. doi: 10.1136/bmjopen-2016-012447.
- Derived from this study: PubMed 38512294Sit SM, Lai AY, Wong HW, Hung KS, Wang MP, Ho SY, Lam TH. Gamified Strength Recognition and Quiz to Enhance COVID-19 Prevention, Knowledge, Behaviors, and Family Well-Being. Games Health J. 2024 Jun;13(3):172-183. doi: 10.1089/g4h.2023.0190. Epub 2024 Mar 20.
- Individual participant dataSharing planned: Yes. Will share after study finished
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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.
Agnes Y Lai, PhD principal investigator
School of Nursing, 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 Digital game in people with Family, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnes Y Lai, PhD (39176779, agneslai@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived improved family well-being (time frame: Baseline and one month). 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 NCT04550065, which also lists 4 linked publications.
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 9 Dec 2021.