Family Health, Happiness and HarmonyNCT04040270
Family Drama Project
A study testing Live drama+DVD+Worksheets and DVD+Worksheets in people with Family Health, Happiness and Harmony and Physical Health, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
A harmonious family relationship has significant effects on the psychological well-being and development of children. Good communication between parents and children is a crucial element for family health, happiness and harmony. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Health, Happiness and Harmony, Physical Health
- What is being tested?
- Live drama+DVD+Worksheets and DVD+Worksheets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,453 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2012to 30 Sep 2013
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary 4 to 6 students in participating primary schools.
Who cannot join
- Students who cannot read Chinese.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3Hs Family Drama Project
A harmonious family relationship has significant effects on the psychological well-being and development of children. Good communication between parents and children is a crucial element for family health, happiness and harmony. However, communication within Hong Kong families is vastly inadequate partly due to our busy urban lifestyle.
The 3Hs Family Drama Project I was to promote health, happiness, harmony (3Hs), healthy eating and physical activity in primary school students. Students watched interactive live drama in schools and were given DVD and worksheets. Students were encouraged to watch the DVD with other family members at home. This study was to evaluate the effectiveness of interactive live drama, DVD and worksheet.
Read the detailed description
3Hs Family Drama Project was an intervention to enhance the 3Hs through increasing interaction and communication between parents and children. Healthy eating and physical activity were also promoted. The drama project staged 100 drama performances in primary schools during the 2012-13 school year. The main targets were Primary 4 to 6 (P4-6) students and their families. Group A students would watch the live drama in school and were encouraged to watch the DVD and finish worksheets with their parents, while group B students would be given a DVD and worksheets and were encouraged to watch the DVD and finish the worksheets with their parents.
The goals of the study were to evaluate the effectiveness of the project to enhance health, happiness, harmony (3Hs), healthy eating and physical activity and participants' satisfaction levels towards the drama project.
Quantitative assessments were used to evaluate the effectiveness and the satisfaction of the project. Questionnaire was distributed to assess the immediate and short-term effects.
- Being tested
- Live drama+DVD+Worksheets, DVD+Worksheets
- Keywords
- Family well-being, Healthy Eating, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live drama+DVD+WorksheetsBehavioural
Interactive live drama was proposed to enhance memories of the audience of health promotion programmes.
The interactive live drama and DVD conveyed educational information on healthy living habits (including physical activity and healthy eating) as well as the importance and suggested methods to enhance family well-being. Students were encouraged to share the information on healthy living habits and watched the DVD with their parents.
Worksheets were given to all students and encouraged to finish the worksheets with their parents.
DVD+WorksheetsBehavioural
The DVD conveyed educational information on healthy living habits (including physical activity and healthy eating) as well as the importance and suggested methods to enhance family well-being. Students were encouraged to share the information on healthy living habits and watched the DVD with their parents.
Worksheets were given to all students and encouraged to finish the worksheets with their parents.
| Study group | Role | What they receive |
|---|---|---|
| Live drama+DVD+Worksheets | Experimental | Primary school students watched an interactive live drama in schools. DVD and worksheets were also distributed to students and asked them to watch the DVD and finish the worksheets with their parents. Receives: Behavioral: Live drama+DVD+Worksheets |
| DVD+Worksheets | Experimental | Primary school students were given DVD and worksheets and they were asked to watch the DVD and finish the worksheets with their parents. After the study finished, the students watched the live drama. Receives: Behavioral: DVD+Worksheets |
| Waitlist control | No intervention | Primary school students received no intervention during the 4-week study period. After the study finished, the students watched the live drama, and DVD with worksheets were distributed to students and they were encouraged to share with their parents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in family health, happiness and harmony (3Hs)
Health, happiness and harmony (3Hs) were assessed by family well-being scale. Perceived family harmony and health were measured by 2 questions on a scale ranging from 1 to 5, whereas perceived family happiness was measured by a single question on a scale ranging from 1 to 4. The higher score the better.
Measured: baseline and 4 weeks
Secondary outcomes (5)
Change in parent-child interactions
Students were asked whether they performed the 12 mentioned activities (e.g. watching movies with parents) in the past 7 days.
Measured: baseline, 1 week and 4 weeks
Change in fruit and vegetable consumption
Students were asked to report the number of days (0-7) of consuming at least 2 servings of fruit and 3 servings of vegetables in the past 7 days.
Measured: baseline, 1 week and 4 weeks
Change in behavior on moderate-to-vigorous physical activity
Students were asked to report the number of days (0-7) of at least 60 minutes moderate-to-vigorous physical activity in the past 7 days.
Measured: baseline, 1 week and 4 weeks
Satisfaction towards the live drama and take-home DVD
Students were asked to rate the live drama, DVD on a scale ranging from 1 to 5. The higher score the more satisfied.
Measured: 1 week and 4 weeks
Change in family health, happiness and harmony (3Hs)
Health, happiness and harmony (3Hs) were assessed by family well-being scale. Perceived family harmony and health were measured by 2 questions on a scale ranging from 1 to 5, whereas perceived family happiness was measured by a single question on a scale ranging from 1 to 4. The higher score the better.
Measured: baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Sep 2012
- Primary completion30 Sep 2013
- Study completion30 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Health, Happiness and HarmonyStudies 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
- 7,453 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Boys' and Girls' Clubs Association of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Sai Yin Ho, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040270
- Sponsor's protocol ID
- UW 12-409
- Status last verified
- Aug 2019
- First submitted
- 29 Jul 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3Hs Family Drama Project
- ClinicalTrials.gov ID
- NCT04040270
- Acronym / sponsor ID
- UW 12-409
- Keywords
- Family well-being, Healthy Eating, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,453 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Boys' and Girls' Clubs Association of Hong Kong
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 31 Jul 2019 (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.
A harmonious family relationship has significant effects on the psychological well-being and development of children. Good communication between parents and children is a crucial element for family health, happiness and harmony. However, communication within Hong Kong families is vastly inadequate partly due to our busy urban lifestyle.
The 3Hs Family Drama Project I was to promote health, happiness, harmony (3Hs), healthy eating and physical activity in primary school students. Students watched interactive live drama in schools and were given DVD and worksheets. Students were encouraged to watch the DVD with other family members at home. This study was to evaluate the effectiveness of interactive live drama, DVD and worksheet.
Detailed description
3Hs Family Drama Project was an intervention to enhance the 3Hs through increasing interaction and communication between parents and children. Healthy eating and physical activity were also promoted. The drama project staged 100 drama performances in primary schools during the 2012-13 school year. The main targets were Primary 4 to 6 (P4-6) students and their families. Group A students would watch the live drama in school and were encouraged to watch the DVD and finish worksheets with their parents, while group B students would be given a DVD and worksheets and were encouraged to watch the DVD and finish the worksheets with their parents.
The goals of the study were to evaluate the effectiveness of the project to enhance health, happiness, harmony (3Hs), healthy eating and physical activity and participants' satisfaction levels towards the drama project.
Quantitative assessments were used to evaluate the effectiveness and the satisfaction of the project. Questionnaire was distributed to assess the immediate and short-term effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Live drama+DVD+Worksheets | Experimental | Behavioral: Live drama+DVD+WorksheetsPrimary school students watched an interactive live drama in schools. DVD and worksheets were also distributed to students and asked them to watch the DVD and finish the worksheets with their parents. |
| DVD+Worksheets | Experimental | Behavioral: DVD+WorksheetsPrimary school students were given DVD and worksheets and they were asked to watch the DVD and finish the worksheets with their parents. After the study finished, the students watched the live drama. |
| Waitlist control | No intervention | –Primary school students received no intervention during the 4-week study period. After the study finished, the students watched the live drama, and DVD with worksheets were distributed to students and they were encouraged to share with their parents. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Primary 4 to 6 students in participating primary schools.
Key exclusion criteria (1 listed)
- Students who cannot read Chinese.
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 |
|---|---|---|
| Live drama+DVD+WorksheetsInteractive live drama was proposed to enhance memories of the audience of health promotion programmes. The interactive live drama and DVD conveyed educational information on healthy living habits (including physical activity and healthy eating) as well as the importance and suggested methods to enhance family well-being. Students were encouraged to share the information on healthy living habits and watched the DVD with their parents. Worksheets were given to all students and encouraged to finish the worksheets with their parents. | Behavioural | Live drama+DVD+Worksheets |
| DVD+WorksheetsThe DVD conveyed educational information on healthy living habits (including physical activity and healthy eating) as well as the importance and suggested methods to enhance family well-being. Students were encouraged to share the information on healthy living habits and watched the DVD with their parents. Worksheets were given to all students and encouraged to finish the worksheets with their parents. | Behavioural | DVD+Worksheets |
Primary outcome
Change in family health, happiness and harmony (3Hs)
Time frame: baseline and 4 weeks
Health, happiness and harmony (3Hs) were assessed by family well-being scale. Perceived family harmony and health were measured by 2 questions on a scale ranging from 1 to 5, whereas perceived family happiness was measured by a single question on a scale ranging from 1 to 4. The higher score the better.
5 secondary outcomes
Change in parent-child interactions
Time frame: baseline, 1 week and 4 weeks
Change in fruit and vegetable consumption
Time frame: baseline, 1 week and 4 weeks
Change in behavior on moderate-to-vigorous physical activity
Time frame: baseline, 1 week and 4 weeks
Satisfaction towards the live drama and take-home DVD
Time frame: 1 week and 4 weeks
Change in family health, happiness and harmony (3Hs)
Time frame: baseline and 1 week
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 7 Aug 2019.
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.
Sai Yin Ho, PhD 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 Live drama+DVD+Worksheets and DVD+Worksheets in people with Family Health, Happiness and Harmony and Physical Health, 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 1 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: finished, as of the sponsor's last update on 7 Aug 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?
Change in family health, happiness and harmony (3Hs) (time frame: baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2019.