Family Drama Project II

August 5, 2019 updated by: The University of Hong Kong

3Hs Family Drama Project (Phase 2)

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 (Phase 2) was an enhanced version of the 3Hs Family Drama Project to promote health, happiness, harmony (3Hs), healthy eating and physical activity in primary school students. Students watched the interactive live drama (long or short version) and are given DVD and worksheets. Students were encouraged to watch the DVD with other family members at home. The present study aimed to evaluate the effectiveness and satisfaction levels of teachers, parents and students towards the drama project.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

3Hs Family Drama Project (Phase 2) 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 conducted 100 drama performances (either in the long or short version) in primary schools during the 2015-16 school year. The main targets were Primary 3 to 5 (P3-5) students and their families. Students would take home a DVD of the drama to watch and worksheets to complete with parents and other family members.

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 of the project. Process evaluations were performed in randomly selected students, parents and teachers to evaluate the process of each component of the program. Qualitative and quantitative assessments were used. Students, parents and teachers were asked to express their views on a questionnaire. Feedback from students was also collected through small group discussions, while that of parents was collected through telephone interviews.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7026

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Local primary schools

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Students: (both the Intervention group and waitlist control group)

  • 1. Students who can read Chinese.
  • 2. Primary 3 to 5 students in participating primary schools.

Parents: (Intervention group only)

  • 1. Parents who can read Chinese.
  • 2. With at least one primary school child.

School teachers: (Intervention group only)

  • 1. Teachers who can read Chinese.

Exclusion Criteria:

  • Students, parents or teachers who cannot read Chinese.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Long live drama
Primary school students watched an interactive long live drama (90 minutes) in schools. DVD and worksheets were also distributed to students and asked them to watch the DVD and finish the worksheets with their parents.
Behavioral: Long live drama

The interactive live 90-minute 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.
Experimental: Short live drama
Primary school students watched an interactive short live drama (60 minutes) in schools. DVD and worksheets were also distributed to students and asked them to watch the DVD and finish the worksheets with their parents.
Behavioral: Short live drama

The interactive live 60-minute 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.
No Intervention: Waitlist control
Primary school students received no intervention during the 3-month study period. After the study finished, the students watched either short or long live drama, and DVD with worksheets were distributed to students and they were invited to share with their parents.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in family health, happiness and harmony (3Hs)
Time Frame: baseline and 3 months
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.
baseline and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in parent-child interactions
Time Frame: baseline, 1 month and 3 months
Students were asked whether they performed the 12 mentioned activities (e.g. watching movies with parents) in the past 7 days.
baseline, 1 month and 3 months
Change in knowledge on healthy eating
Time Frame: baseline, 1 month and 3 months
Students were asked by 4 questions: 1)Do typical photo chips contain salt; 2)Will drinking sugary drinks affect weight; 3)Will more sedentary behaviours affect weight and 4)How many cubes of sugar are in a can of coke. The former 3 questions were given with 4 options, while the latter was given with 8 options. Each corrected answer scores 1 and a sum of scores from the 4 questions were deemed a measurement of knowledge.
baseline, 1 month and 3 months
Change in behavior on physical activity
Time Frame: baseline, 1 month and 3 months
Students were asked to report the number of days (0-7) of simple exercise and at least 60 minutes moderate-to-vigorous physical activity in the past 7 days.
baseline, 1 month and 3 months
Satisfaction towards the live drama, song and interactive parts
Time Frame: Immediately after the live drama
Students were asked to rate the live drama, song and interactive parts on a scale ranging from 1 to 5 scale and the lower score the more satisfied.
Immediately after the live drama
Change in family health, happiness and harmony (3Hs)
Time Frame: baseline and 1 month
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.
baseline and 1 month
Changes in body mass index
Time Frame: baseline and 1 month
Body mass index was calculated from the measured weight and height
baseline and 1 month
Changes in physical fitness (muscle strength)
Time Frame: baseline and 1 month
Muscle strength was assessed through a dynamometer
baseline and 1 month
Changes in physical fitness (muscle endurance)
Time Frame: baseline and 1 month
Muscle endurance of legs was assessed through a simple fitness test "Squat".
baseline and 1 month
Changes in physical fitness (muscle endurance)
Time Frame: baseline and 1 month
Muscle endurance was assessed through a simple fitness test "Plank".
baseline and 1 month
Change in fruit and vegetable consumption
Time Frame: baseline, 1 month and 3 months
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.
baseline, 1 month and 3 months
Satisfaction towards the DVD and worksheets
Time Frame: 1 month
Students were asked to rate the DVD and worksheets on a scale ranging from 1 to 5 and the lower score the more satisfied.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Boys' and Girls' Clubs Association of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW 15-464

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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