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Smartphone Parent-child Partner Exercises Application Study

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ClinicalTrials.gov Identifier: NCT03279354
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Professor Cindy L.K. Lam, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Family Move app intervention Behavioral: "HK FitNuts" app intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Family Move app intervention
Behavioral: Family Move app intervention
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.

Placebo Comparator: Control group
"HK FitNuts" app intervention
Behavioral: "HK FitNuts" app intervention
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.




Primary Outcome Measures :
  1. Change from Baseline Child Psychosocial Health at 1 month and 6 month post intervention [ Time Frame: baseline, 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.

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


Secondary Outcome Measures :
  1. Change from Baseline Parental Mental and Physical Health at 1 month and 6 month post intervention [ Time Frame: baseline, 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.

  2. Change from Baseline Child SDQ Total Difficulties Scores at 1 month and 6 month post intervention [ Time Frame: baseline, 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

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279354


Locations
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Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Cindy Lo Kuen Lam The University of Hong Kong
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Responsible Party: Professor Cindy L.K. Lam, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03279354    
Other Study ID Numbers: UW17-179
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Cindy L.K. Lam, The University of Hong Kong:
Health-related quality of life
Physical activity
Smartphone application