NCT03279354

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

1.6 years

First QC Date

September 6, 2017

Last Update Submit

December 7, 2024

Conditions

Keywords

Health-related quality of lifePhysical activitySmartphone application

Outcome Measures

Primary Outcomes (2)

  • 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.

    baseline, 1 month, and 6 month post intervention

  • 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.

    baseline, 1 month, and 6 month post intervention

Secondary Outcomes (4)

  • Change from Baseline Parental Mental and Physical Health at 1 month and 6 month post intervention

    baseline, 1 month, and 6 month post intervention

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

    baseline, 1 month, and 6 month post intervention

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

    baseline, 1 month, and 6 month post intervention

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

    baseline, 1 month, and 6 month post intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Family Move app intervention

Behavioral: Family Move app intervention

Control group

PLACEBO COMPARATOR

"HK FitNuts" app intervention

Behavioral: "HK FitNuts" app intervention

Interventions

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.

Intervention group

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.

Control group

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Cindy Lo Kuen Lam

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 12, 2017

Study Start

June 1, 2017

Primary Completion

December 31, 2018

Study Completion

June 30, 2019

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations