Family ResearchNCT06626100
A Digital Game on Promoting Family Well-being
A study testing Exercise-themed game and Diet-themed game in people with Family Research and Family-centered Care, 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 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Research, Family-centered Care
- What is being tested?
- Exercise-themed game and Diet-themed game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Oct 2024to 31 Mar 2026
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Chinese-speaking;
- Parental consent for those under 18;
- Able to understand and play the game;
- Has a smartphone.
Who cannot join
- Individuals who cannot meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Shirley M Sit, MPhil contact
Hong Kong1 site
The University of Hong Kong
Hong Kong
Agnes Y Lai, PhD, 85239176283, agneslai@hku.hk
Shirley M Sit, MPhil, ssit@connect.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 conduct an online survey to assess the use of games and gamification for health promotion, as well as a family-based randomized controlled trial to promote healthy living.
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 beyond the COVID-19 pandemic. Additionally, the pandemic led to increased sedentary behavior and unhealthy eating. New, innovative health promotion strategies and approaches to increase physical activity and healthy diet and enhance well-being are needed.
This study aims to investigate and use a game-based approach to enhance knowledge and behaviours on healthy living and family well-being. We will conduct quantitative and qualitative evaluation. The findings would provide 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 Research, Family-centered Care
- Being tested
- Exercise-themed game, Diet-themed game
- Keywords
- Gamification, Family well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-themed gameBehavioural
The intervention includes three parts: quiz questions on knowledge on and benefits of exercise; monitored step count using smartphone tracker; whatsapp reminders on the benefits of exercise.
Diet-themed gameBehavioural
The intervention includes two parts: quiz questions on knowledge on and benefits of healthy diet; whatsapp reminders on the benefits of healthy diet.
| Study group | Role | What they receive |
|---|---|---|
| Exercise-themed game | Experimental | The intervention includes an exercise-themed quiz game and monitored step count. Receives: Behavioral: Exercise-themed game |
| Diet-themed game | Active comparator | The intervention includes a diet-themed quiz game. Receives: Behavioral: Diet-themed game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step count
Average daily step count
Measured: Baseline and one month
Secondary outcomes (4)
Perceived improved family happiness
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
Game satisfaction score
Overall game rating (on a scale of 0-5, higher scores indicate higher satisfaction).
Measured: 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
Self-reported healthy habits
Change assessed by frequency-based questions related to exercise levels and consumption of fruits and vegetables (scores from 0 to 7 days, higher scores indicate more engagement in healthy habits)
Measured: Baseline and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Mar 2026 (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 Family ResearchStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626100
- Sponsor's protocol ID
- UW 20-353-2
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share after the study is completed
Publications
Runacres A, Mackintosh KA, Knight RL, Sheeran L, Thatcher R, Shelley J, McNarry MA. Impact of the COVID-19 Pandemic on Sedentary Time and Behaviour in Children and Adults: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Oct 27;18(21):11286. doi: 10.3390/ijerph182111286.
PubMed 34769800Ameryoun 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 27707829
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. 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
- NCT06626100
- Acronym / sponsor ID
- UW 20-353-2
- Conditions
- Family Research, Family-centered Care
- Keywords
- Gamification, Family well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 3 Oct 2024 (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 conduct an online survey to assess the use of games and gamification for health promotion, as well as a family-based randomized controlled trial to promote healthy living.
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 beyond the COVID-19 pandemic. Additionally, the pandemic led to increased sedentary behavior and unhealthy eating. New, innovative health promotion strategies and approaches to increase physical activity and healthy diet and enhance well-being are needed.
This study aims to investigate and use a game-based approach to enhance knowledge and behaviours on healthy living and family well-being. We will conduct quantitative and qualitative evaluation. The findings would provide 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise-themed game | Experimental | Behavioral: Exercise-themed gameThe intervention includes an exercise-themed quiz game and monitored step count. |
| Diet-themed game | Active comparator | Behavioral: Diet-themed gameThe intervention includes a diet-themed quiz game. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese-speaking;
- Parental consent for those under 18;
- Able to understand and play the game;
- Has a smartphone.
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 |
|---|---|---|
| Exercise-themed gameThe intervention includes three parts: quiz questions on knowledge on and benefits of exercise; monitored step count using smartphone tracker; whatsapp reminders on the benefits of exercise. | Behavioural | Exercise-themed game |
| Diet-themed gameThe intervention includes two parts: quiz questions on knowledge on and benefits of healthy diet; whatsapp reminders on the benefits of healthy diet. | Behavioural | Diet-themed game |
Primary outcome
Step count
Time frame: Baseline and one month
Average daily step count
4 secondary outcomes
Perceived improved family happiness
Time frame: Baseline and one month
Game satisfaction score
Time frame: One month
Family well-being knowledge and behaviors
Time frame: Baseline and one month
Self-reported healthy habits
Time frame: Baseline and one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Background: PubMed 34769800Runacres A, Mackintosh KA, Knight RL, Sheeran L, Thatcher R, Shelley J, McNarry MA. Impact of the COVID-19 Pandemic on Sedentary Time and Behaviour in Children and Adults: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Oct 27;18(21):11286. doi: 10.3390/ijerph182111286.
- 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.
- Individual participant dataSharing planned: Yes. Will share after the study is completed
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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.
Shirley M Sit, MPhil contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise-themed game and Diet-themed game in people with Family Research and Family-centered Care, 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 4 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 3 Oct 2024. 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 (85239176779, agneslai@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step count (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 NCT06626100, 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 3 Oct 2024.