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Physical ActivityNCT03279354

Smartphone Parent-child Partner Exercises Application Study

A study testing Family Move app intervention and "HK FitNuts" app intervention in people with Physical Activity, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Building upon our previous groundwork including the development of the FAMILY MOVE app and the pilot study, we will further evaluate the effectiveness of a simple parent-child partner exercise programme delivered by our FAMILY MOVE app on children's health-related quality of life through a single blinded randomized… Read more about this study

Who is it for?
Ages 7 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Family Move app intervention and "HK FitNuts" app intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
186 participants
Where
1 siteHong Kong
Study dates
1 Jun 2017to 30 Jun 2019
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 7 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Family monthly household income does not exceed 75% of Hong Kong's median monthly household income at enrollment;
  • Family has at least one parent and one child aged 7 to16 years at enrollment;
  • At least one parent has a smartphone with iOS or Android mobile operating system.

Who cannot join

  • Both parents and children cannot understand or read traditional Chinese
  • Parents or children with a medical condition limiting ability to exercise
  • Previous use of the apps of interest

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomized Controlled Trial of the Effectiveness of a Smartphone Parent-child Partner Exercises Application on Enhancing Health-related Quality of Life of Children From Low-income Families

Building upon our previous groundwork including the development of the FAMILY MOVE app and the pilot study, we will further evaluate the effectiveness of a simple parent-child partner exercise programme delivered by our FAMILY MOVE app on children's health-related quality of life through a single blinded randomized placebo-controlled trial (RCT). This RCT will sample 286 low-income parent-child pairs recruited from low income families in the community. Study participants will be randomized after baseline assessment by an independent statistician using computer randomization tool with 1:1 allocation ratio to either the FAMILY MOVE app intervention group or the HK FitNuts app control group. After both groups have completed the intervention study and follow up measurements at 1 month, 6 months and 12 months after intervention, the control group will receive the same FAMILY MOVE app. Outcome assessments will be conducted by a trained interviewer blinded to the subject group allocation at baseline, 1 month, 6 months and 12 months after intervention.

Read the detailed description

The health benefits of regular physical activity (PA) are well recognized. An active lifestyle benefits health-related quality of life (HRQoL) through its effect on physical and mental health. Adults and children who regularly participate in PA reported better health-related quality of life (HRQoL) compared to those who do not. HRQoL is a multidimensional construct that captures the impact of illness on the person's ability to live a fulfilling life. Physical, social and psychological functioning are the most important domains of HRQoL in adults and children. Although many individuals realize the beneficial effects of PA, some lack motivation to sustain the recommended workout levels whilst others lack the means.

Physical activity to promote HRQOL In particular, parents living on a low income face a number of practical barriers such as unaffordable cost, lack of childcare support and limited time after work to engage in PA. Inactive parents will have difficulty to set PA examples and standards for their children. The amount of time they spend with children in activities together is also limited. Community programmes on parent-child partner exercises have the potential to enhance HRQoL in both parents and children by increasing their PA level and quality parent-child interactions. However, engaging low-income adults and children in PA programmes is challenging because of their busy schedule and limited access to PA facilities. Ubiquitous technologies such as web-based programme and smartphone applications (apps) may overcome the barriers to PA interventions for this difficult-to-reach population. Exercises for these families need to be simple and practical. The introduction of basic partner stretching and strength exercises that requires the parents and their children to help each other could be a good start for inactive families to change toward an active lifestyle. In addition to improved fitness, the shared joy and support during parent-child partner exercises may promote positive moods and better life satisfaction, i.e. HRQoL.

Mobile technology to promote PA Mobile device usage is rapidly increasing and half of the worldwide mobile phone subscriptions are in the Asia Pacific region. Advanced mobile devices such as smartphones are equipped with features of personal computer operating system such as persistent network connectivity and downloadable apps. Smartphone apps that combine textual information with gaming elements such as competition, scoreboard and point are growing in popularity as health promoting tools. These gaming elements harness people's aversion of losses which motivate them to keep doing exercises to achieve activity goals. In addition, apps also enable users to monitor, record and reflect on their behaviour and lifestyle in a more convenient and less stigmatizing way than traditional health interventions. However, their effectiveness in low-income families especially on HRQoL in children is unknown. Furthermore, most of the available apps are produced in Western populations and in English, which limit their applicability to low-income Chinese families. The few PA promotion apps that are available in Chinese language mainly target at individual adult users without considering whether the exercise moves are appropriate for children, which make it difficult to use in family intervention.

Previous work done by the research team Since 2012, our research team, in collaboration with a philanthropic foundation in Hong Kong (Kerry Group Foundation (Hong Kong) Limited (KGKF)), has provided various health empowerment interventions and comprehensive health assessment to a group of low income families in Hong Kong (166 low-income families from Tung Chung and 205 families with similar socio-demographic background from other districts of Hong Kong). We found that local Chinese adults from low-income families had poorer HRQoL than the general population [14]. Their children also had poorer HRQOL and more behavioral problems [15]. Results of our preliminary analysis showed that both parents and children from low-income families reported lower levels of PA per week than the recommended levels by World Health Organization (WHO). There was a positive correlation (r=0.25, p=0.001) between the total weekly time of physical activities (including walking, moderate-intensity or/and vigorous-intensity activities) in parents and children. Moreover, we delivered a pilot parent-child exercise course in October-November 2016 and found a significant gain of 12.5 points in the scores of Mental Health scale of Child Health Questionnaire - Parent Form - 50 (CHQ-PF50) of participating children. Our research team is working towards delivering this parent-child partner exercise programme as a smartphone app.

The development of the smartphone app on simple parent-child partner exercises, which is funded by a philanthropic foundation in Hong Kong (Kerry Group Foundation (Hong Kong) Limited (KGKF)) is currently in progress.

After expert consultation and review of relevant literature, we are developing a smartphone app "FAMILY MOVE" in Chinese language with the following features:

  • Account login with a unique, anonymous participant number for each user family which would allow us to keep record of the user's frequency and duration of use of our app
  • A fully automated 8-week parent-child partner exercise programme (release of Level 1 moves in Week 1-2; Level 2 moves in Week 3-4; Level 3 moves in Week 5-6; revision of all moves in Week 7-8) for young children aged 6 to 10 years and adolescents aged 11 years or above, respectively
  • Each level consists of one warm-up clip (1 minute), 4 short exercise move demonstration clips with audio instructions (30 seconds per clip), and 1 long dance clip (3 minutes) integrating the four exercise moves with background music
  • Points will be given to users after they have viewed an exercise move video clip. More points would be awarded to more difficult moves
  • The scoreboard will display personal score as well as the scores of the top 5 users
  • Three push notifications per week as prompts to motivate users to keep doing exercises

The exercise moves that the parent and children practiced in the pilot exercise course had been filmed after modification based on opinions from PA experts and would be used as demonstration videos in the app.

A pre-post pilot study will be conducted in 2017 on 166 parent-child pairs recruited from the group of families living in Tung Chung district in our cohort after the FAMILY MOVE app is produced. Parents of eligible families will be notified by SMS ("Short Message Service") and asked whether they agree or not to receive the FAMILY MOVE app as part of our health empowerment study. Parents who agree to participate in this pilot 8-week intervention study will be asked to complete the same set of questionnaires on their own HRQOL, PA levels and mental health condition and their children's HRQOL, behavior and PA levels at each assessment time point (baseline, 1-month and 6-month post intervention).

Building upon such groundwork and existing evidence, in the present study our team would like to evaluate further by launching a randomized-controlled trial (RCT) examining the effectiveness of a simple parent-child partner exercise programme delivered as a smartphone app "FAMILY MOVE" in enhancing the HRQoL and PA level of children from low-income families.

Aims and Hypotheses to be Tested:

Study Objectives

  1. To evaluate the effectiveness of the smartphone app "FAMILY MOVE" in improving the HRQoL of children;
  2. To evaluate the effectiveness of the smartphone app "FAMILY MOVE" in improving the PA levels of children;
  3. To explore the associations between "FAMILY MOVE" app usage and HRQoL and PA of children.

Study hypotheses

  1. Compared to the control group, children from the intervention group will show better HRQoL (measured by the Psychosocial Summary scores of the Child Health Questionnaire - Parent Form - 50 (CHQ-PF50)) at 1 month, 6 months and 12 months after intervention.
  2. Compared to the control group, children from the intervention group will show greater PA measured by the METS (Metabolic Equivalent for Task) -minutes/week at 1 month, 6 months and 12 months after intervention.
  3. There is a positive correlation of improvement in HRQoL and PA levels of children with the time they spend on the FAMILY MOVE app.
Being tested
Family Move app intervention, "HK FitNuts" app intervention
Keywords
Health-related quality of life, Physical activity, Smartphone application
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Move app interventionBehavioural

    All the recruited parent-child pairs will be randomized after baseline assessment by an independent statistician using computer randomization tool to either the FAMILY MOVE app intervention group or the HK FitNuts app control group with a 1:1 allocation ratio. Although both groups receive a stand-alone app, the apps have distinct design features: use of competition and point elements (FAMILY MOVE app) or use of traditional demonstration elements (HK FitNuts app). After both groups have completed the 8-week intervention study and follow up measurements at 1 month, 6 months and 12 months after intervention, the control group will receive the same FAMILY MOVE app. Outcome assessments will be conducted by a trained interviewer blinded to the subject group allocation.

  • "HK FitNuts" app interventionBehavioural

    The parent-child pairs in the control group will be given a link to download the "HK FitNuts" app which was developed by Hong Kong Association of Sports Medicine and Sports Science, Department of Orthopaedics \& Traumatology of the Chinese University of Hong Kong and Hong Kong Dietitians Association to promote healthy lifestyle in Hong Kong. The app includes short video clips demonstrating basic individual exercise moves and provides other textual information related to PA. However, it does not have push notification function. In order to ensure that the intervention and control group will receive equal attention from our research team, we shall send a text about HK FitNuts and general exercise information to participants in the control group three times per week. Same as participants in the intervention group, the control group will also be asked to provide their weekly app usage and PA pattern by completing an online log at the end of each intervention week.

Study groups in NCT03279354
Study groupRoleWhat they receive
Intervention groupExperimentalFamily Move app intervention
Receives: Behavioral: Family Move app intervention
Control groupPlacebo comparator"HK FitNuts" app intervention
Receives: Behavioral: "HK FitNuts" app intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Child Psychosocial Health at 1 month and 6 month post intervention

    Chinese Child Health Questionnaire - Parent Form - 50 (CHQ-PF50); including 12 domain scales (General Health, Physical Functioning, Role/Social Limitations - Emotional/Behavioral, Role/Social Limitations - Physical, Bodily Pain/Discomfort, Behavior, Mental Health, Self-Esteem, Parental Impact - Emotion, Parental Impact - Time, Family Activities, and Family Cohesion) and 2 summary scores (Physical Summary Score and Psychosocial Summary Score). Higher scores indicate better HRQoL.

    Measured: baseline, 1 month, and 6 month post intervention

  2. Change from Baseline Child Total Physical Activity Score (MET-minutes/week) at 1 month and 6 month post intervention

    International Physical Activity Questionnaire - Short Form - Chinese version (IPAQ-SF); including seven questions on the frequency and duration of time spent in physical activity in the past 7 days to calculate a score for each domain (walking, moderate-intensity activities and vigorous-intensity activities) and an overall grand total expressed in MET-minutes/week.

    Measured: baseline, 1 month, and 6 month post intervention

Secondary outcomes (4)
  1. Change from Baseline Parental Mental and Physical Health at 1 month and 6 month post intervention

    Chinese (Hong Kong) translation of 12-item Short-Form Health Survey-version 2 (SF-12v2); a generic HRQoL measure including 8 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) and two (mental health and physical health) summary scores.

    Measured: baseline, 1 month, and 6 month post intervention

  2. Change from Baseline Child SDQ Total Difficulties Scores at 1 month and 6 month post intervention

    Chinese Strength and Difficulties Questionnaire (SDQ); including 5 subscales of emotional symptoms, conduct problems, hyperactivity/inattention, prosocial behaviors and peer relationship problems. Higher scores indicate worse behavior for all except the prosocial behavior score. The scores of the four subscales that measure symptoms or problems can be summated to a total difficulties score

    Measured: baseline, 1 month, and 6 month post intervention

  3. Change from Baseline Parent Total Physical Activity Score (MET-minutes/week) at 1 month and 6 month post intervention

    International Physical Activity Questionnaire - Short Form - Chinese version (IPAQ-SF); including seven questions on the frequency and duration of time spent in physical activity in the past 7 days to calculate a score for each domain (walking, moderate-intensity activities and vigorous-intensity activities) and an overall grand total expressed in MET-minutes/week.

    Measured: baseline, 1 month, and 6 month post intervention

  4. Change from Baseline Parental DASS scores on each subscale (Depression, Anxiety and Stress) at 1 month and 6 month post intervention

    Chinese Depression Anxiety Stress Scale - 21 (DASS - 21); including 3 subscales, each with 7 items rating the severity/frequency of anxiety symptoms, depression symptoms, and stress respectively

    Measured: baseline, 1 month, and 6 month post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2017
  2. Study start1 Jun 2017
  3. Primary completion31 Dec 2018
  4. Study completion30 Jun 2019

Resources

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
Health services research
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03279354
Sponsor's protocol ID
UW17-179
Status last verified
Dec 2024
First submitted
6 Sep 2017
Last updated
12 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wong RSM, Yu EYT, Wong TW, Fung CSC, Choi CSY, Or CKL, Liu KSN, Wong CKH, Ip P, Lam CLK. Development and pilot evaluation of a mobile app on parent-child exercises to improve physical activity and psychosocial outcomes of Hong Kong Chinese children. BMC Public Health. 2020 Oct 14;20(1):1544. doi: 10.1186/s12889-020-09655-9.

    PubMed 33054753

Questions about this trial

What is this clinical trial studying?

A study testing Family Move app intervention and "HK FitNuts" app intervention in people with Physical Activity, 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 3 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 12 Dec 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. Some participants in this study may receive a placebo. 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 from Baseline Child Psychosocial Health at 1 month and 6 month post intervention (time frame: baseline, 1 month, and 6 month post intervention). The study lists 2 primary outcomes in all. 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 NCT03279354, which also lists 1 linked publication.

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 12 Dec 2024.

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Clinical Trial NCT03279354 | AzTrials