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Effects of Parental Involvement in Exergames Play on Physical and Mental Health on Overweight and Obese Male Adolescent

Primary Purpose

Physical Inactivity, Overweight and Obesity, Psychosocial Problem

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cooperative versus competitive AVG play
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Physical Inactivity focused on measuring Parental involvement, Exergame, Physical activity, Psychosocial

Eligibility Criteria

13 Years - 14 Years (Child)MaleAccepts Healthy Volunteers

Inclusion Criteria: The family needs to install a television and connect to the Internet The family has never purchased a game console similar to AVG before ensure that at least one parent has enough time to accompany his or her child to complete the experimental task in a week BMI percentile should be more than 85 there are no other sports besides daily physical activities The parents of the subjects agreed with their children to participate in the experiment and were willing to participate with their children. Exclusion Criteria: Clinically diagnosed with mental illness Clinically diagnosed chronic disease Relevant weight loss drugs taken within half a year

Sites / Locations

  • Universiti Putra MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Two player mode(parental involvement) in AVG play

Single player mode in AVG play

children did not engage in any AVGs play

Arm Description

the parent involvement group requires one parent to accompany the child to complete the experimental task

the single-person model and the child need to complete the experimental task under the parent's supervision.

children did not engage in any AVGs play nor any other structured school-based PA programs beyond physical education.

Outcomes

Primary Outcome Measures

Physical Activity Questionnaire for Children (PAQ-C)
It is a self-filled and retrospective physical activity level questionnaire for children and adolescents (PAQ-C)(aged 7 to 18). On the one hand, PAQ-C measures the general level of physical activity by scoring (continuous variable) rather than measuring the intensity, frequency, and duration of physical activity, which improves its operational and theoretical feasibility; On the other hand, PAQ-C helps to improve time efficiency and reduce capital costs, making it easy to manage and operate.Likert's 5-level scoring method adopted five numbers of scores from 1(strongly disagree) to 5 (strongly agree) were used, and the scores were converted into linear scales. Higher scores indicated the higher PA level.
Pediatric Quality of Life Inventory 4.0 (PedsQL)
The scale is used to assess the quality of life of young adults in the past seven days. The scale included 23 items, which assessed the physical (8 items), social (5 items), school (5 items), and emotional (5 items). Likert's 5-level scoring method adopted five numbers of scores from 0 (never) to 4 (almost always) were used, and the scores were converted into linear scales. Higher scores indicated the higher quality of life.
The Self-Efficacy for School Physical Activity Questionnaire
Physical activity efficacy scale [the Self-Efficacy for School Physical Activity Questionnaire (SEPAQ)] to assess task related efficacy in the main school activity behavioural.Using the scale, please check the appropriate response (0-100%) for each question.Higher scores indicated the higher self-efficacy level
Parent child relational quality scale
From the perspective of adolescents, this scale includes 29 items and is divided into four dimensions: parent-child intimacy, parent-child conflict, parent-child trust, and parent-child satisfaction to measure the quality of the parent-child relationship. Scoring: This questionnaire adopts a 5-point Likert scale, with 1-5 representing increasing support (1=strongly disagree; 2=Disagree;3=Not necessarily;4=agree; 5=strongly agree).Higher scores indicated the higher parent child relational quality
Parental Support Scale for Children's Physical Exercise
The questionnaire includes 20 items. From the parent's perspective, parents' support for children's physical activity behavior is measured from five dimensions: verbal encouragement, physical activity model, logistical support, behavior encouragement, and physical activity preference. Scoring: This questionnaire adopts a 5-point Likert scale, with 1-5 representing increasing support (1=never; 2=rarely; 3=sometimes; 4=often; 5=always.Higher scores indicated the higher parental support level

Secondary Outcome Measures

Physical Activity Questionnaire for Children (PAQ-C)
It is a self-filled and retrospective physical activity level questionnaire for children and adolescents (PAQ-C)(aged 7 to 18). On the one hand, PAQ-C measures the general level of physical activity by scoring (continuous variable) rather than measuring the intensity, frequency, and duration of physical activity, which improves its operational and theoretical feasibility; On the other hand, PAQ-C helps to improve time efficiency and reduce capital costs, making it easy to manage and operate.Likert's 5-level scoring method adopted five numbers of scores from 1(strongly disagree) to 5 (strongly agree) were used, and the scores were converted into linear scales. Higher scores indicated the higher PA level.
Pediatric Quality of Life Inventory 4.0 (PedsQL)
The scale is used to assess the quality of life of young adults in the past seven days. The scale included 23 items, which assessed the physical (8 items), social (5 items), school (5 items), and emotional (5 items). Likert's 5-level scoring method adopted five numbers of scores from 0 (never) to 4 (almost always) were used, and the scores were converted into linear scales. Higher scores indicated the higher quality of life.
The Self-Efficacy for School Physical Activity Questionnaire
Physical activity efficacy scale [the Self-Efficacy for School Physical Activity Questionnaire (SEPAQ)] to assess task related efficacy in the main school activity behavioural.Using the scale, please check the appropriate response (0-100%) for each question.Higher scores indicated the higher self-efficacy level
Parent child relational quality scale
From the perspective of adolescents, this scale includes 29 items and is divided into four dimensions: parent-child intimacy, parent-child conflict, parent-child trust, and parent-child satisfaction to measure the quality of the parent-child relationship. Scoring: This questionnaire adopts a 5-point Likert scale, with 1-5 representing increasing support (1=strongly disagree; 2=Disagree;3=Not necessarily;4=agree; 5=strongly agree).Higher scores indicated the higher parent child relational quality
Parental Support Scale for Children's Physical Exercise
The questionnaire includes 20 items. From the parent's perspective, parents' support for children's physical activity behavior is measured from five dimensions: verbal encouragement, physical activity model, logistical support, behavior encouragement, and physical activity preference. Scoring: This questionnaire adopts a 5-point Likert scale, with 1-5 representing increasing support (1=never; 2=rarely; 3=sometimes; 4=often; 5=always.Higher scores indicated the higher parental support level

Full Information

First Posted
February 18, 2023
Last Updated
March 13, 2023
Sponsor
Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05769374
Brief Title
Effects of Parental Involvement in Exergames Play on Physical and Mental Health on Overweight and Obese Male Adolescent
Official Title
Effects of Parental Involvement in Active Video Games Play on Physical Activity, Psychosocial Beliefs and Parent-child Relational Quality on Overweight and Obese Male Adolescents in China
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
April 10, 2023 (Anticipated)
Study Completion Date
June 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In recent years, with the rising obesity rate, overweight and obesity have become a hot issue of public health. As a sensitive and special group, teenagers shoulder the heavy responsibility of building the motherland, so their health is also the focus of scholars and experts. As a new type of sports game, active video game(AVG) has been proved by many studies to be able to effectively improve the sedentary behavior of teenagers, and can completely become a substitute for today's popular smart phones. In addition, due to the increase of overweight and obese teenagers, a series of psychological problems, such as anxiety, depression, and low self-esteem, also troubled this group. Some researchers can effectively improve the psychological status of the subjects through the intervention experiment of AVG. However, there are few studies on psychosocial beliefs at present, and the impact of psychosocial variables such as self-efficacy, social support and quality of life on overweight and obese groups is extremely important. Moreover, due to the impact of the COVID-19 epidemic, the relationship between family members will also change, especially the alienation and rigidity of the relationship between children and parents will show a significant growth trend. Therefore, this study mainly takes AVG play with parents' participation as the main intervention means to influence the physical activities, psychosocial beliefs and quality of parent-child relationship of the experimental target.
Detailed Description
In this study, three groups, namely the control group (children did not engage in any AVGs play nor any other structured school-based PA programs beyond physical education), two experimental groups (parental involvement in AVG play and single-player mode). It should be noted that the parent involvement group requires one parent to accompany the child to complete the experimental task, while the single-person model and the child need to complete the experimental task under the parent's supervision. The sample is 13-14-year-old Chinese overweight and obese male middle school students. Researchers will establish three groups in the WeChat platform to facilitate communication with each group of experimental subjects. A study of 73 previously inactive, typically developing children showed initially high intrinsic motivation to use an AVGs system, which disappeared by week seven of the survey. However, the overall results of a study indicate that the use of AVGs may have increased self-reported levels of PA in overweight or obese children over 12 weeks. Given that the group in this study is junior high school students in grade one or two, with heavy learning tasks, the research period is eight weeks. Based on the articles, according to the characteristics of the Nintendo Wii, to increase the subject's compliance with the game and maximize the training effect, each gaming session consisted of the upper body, cardio,and sports games . Routines were pre-determined and varied daily, gradually increasing in difficulty throughout the program. AVG participants were tracked every time for individual progress in the two experimental groups by earning points and expending calories, which were continuously reported by the Wii console as the participants played. After each game session, the parents will export the data from the game console and send it to the researcher through WeChat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Overweight and Obesity, Psychosocial Problem
Keywords
Parental involvement, Exergame, Physical activity, Psychosocial

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this experiment, experiment group 1 is AVG with parents' participation, that is, the experiment object is accompanied by parents to complete the experiment, and experiment group 2 is to complete the experiment task by themselves under the supervision of parents. The control group did not undergo any AVG intervention and maintained the same physical activity as usual.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Two player mode(parental involvement) in AVG play
Arm Type
Experimental
Arm Description
the parent involvement group requires one parent to accompany the child to complete the experimental task
Arm Title
Single player mode in AVG play
Arm Type
Experimental
Arm Description
the single-person model and the child need to complete the experimental task under the parent's supervision.
Arm Title
children did not engage in any AVGs play
Arm Type
Active Comparator
Arm Description
children did not engage in any AVGs play nor any other structured school-based PA programs beyond physical education.
Intervention Type
Device
Intervention Name(s)
cooperative versus competitive AVG play
Intervention Description
The duration of the study was 8 weeks and the frequency was 60 minutes three times a week. In the first two weeks, three games, Golf, Just Dance and Tennis, will be selected to experiment on easy and normal difficulty respectively. In the three weeks from week 3 to Week 5, Bowling, Shape Boxing and Table tennis will be selected for the experiment with easy, normal and difficult difficulties respectively. In the last three weeks, Rowing, Family ski and Baseball will be selected to carry out experiments with easy, ordinary and difficult difficulty respectively.Additionally,participants in control group did not participate in any AVG intervention and maintained their daily physical activity behaviors
Primary Outcome Measure Information:
Title
Physical Activity Questionnaire for Children (PAQ-C)
Description
It is a self-filled and retrospective physical activity level questionnaire for children and adolescents (PAQ-C)(aged 7 to 18). On the one hand, PAQ-C measures the general level of physical activity by scoring (continuous variable) rather than measuring the intensity, frequency, and duration of physical activity, which improves its operational and theoretical feasibility; On the other hand, PAQ-C helps to improve time efficiency and reduce capital costs, making it easy to manage and operate.Likert's 5-level scoring method adopted five numbers of scores from 1(strongly disagree) to 5 (strongly agree) were used, and the scores were converted into linear scales. Higher scores indicated the higher PA level.
Time Frame
Before the experiment
Title
Pediatric Quality of Life Inventory 4.0 (PedsQL)
Description
The scale is used to assess the quality of life of young adults in the past seven days. The scale included 23 items, which assessed the physical (8 items), social (5 items), school (5 items), and emotional (5 items). Likert's 5-level scoring method adopted five numbers of scores from 0 (never) to 4 (almost always) were used, and the scores were converted into linear scales. Higher scores indicated the higher quality of life.
Time Frame
Before the experiment
Title
The Self-Efficacy for School Physical Activity Questionnaire
Description
Physical activity efficacy scale [the Self-Efficacy for School Physical Activity Questionnaire (SEPAQ)] to assess task related efficacy in the main school activity behavioural.Using the scale, please check the appropriate response (0-100%) for each question.Higher scores indicated the higher self-efficacy level
Time Frame
Before the experiment
Title
Parent child relational quality scale
Description
From the perspective of adolescents, this scale includes 29 items and is divided into four dimensions: parent-child intimacy, parent-child conflict, parent-child trust, and parent-child satisfaction to measure the quality of the parent-child relationship. Scoring: This questionnaire adopts a 5-point Likert scale, with 1-5 representing increasing support (1=strongly disagree; 2=Disagree;3=Not necessarily;4=agree; 5=strongly agree).Higher scores indicated the higher parent child relational quality
Time Frame
Before the experiment
Title
Parental Support Scale for Children's Physical Exercise
Description
The questionnaire includes 20 items. From the parent's perspective, parents' support for children's physical activity behavior is measured from five dimensions: verbal encouragement, physical activity model, logistical support, behavior encouragement, and physical activity preference. Scoring: This questionnaire adopts a 5-point Likert scale, with 1-5 representing increasing support (1=never; 2=rarely; 3=sometimes; 4=often; 5=always.Higher scores indicated the higher parental support level
Time Frame
Before the experiment
Secondary Outcome Measure Information:
Title
Physical Activity Questionnaire for Children (PAQ-C)
Description
It is a self-filled and retrospective physical activity level questionnaire for children and adolescents (PAQ-C)(aged 7 to 18). On the one hand, PAQ-C measures the general level of physical activity by scoring (continuous variable) rather than measuring the intensity, frequency, and duration of physical activity, which improves its operational and theoretical feasibility; On the other hand, PAQ-C helps to improve time efficiency and reduce capital costs, making it easy to manage and operate.Likert's 5-level scoring method adopted five numbers of scores from 1(strongly disagree) to 5 (strongly agree) were used, and the scores were converted into linear scales. Higher scores indicated the higher PA level.
Time Frame
Mid-test:end of week 4
Title
Pediatric Quality of Life Inventory 4.0 (PedsQL)
Description
The scale is used to assess the quality of life of young adults in the past seven days. The scale included 23 items, which assessed the physical (8 items), social (5 items), school (5 items), and emotional (5 items). Likert's 5-level scoring method adopted five numbers of scores from 0 (never) to 4 (almost always) were used, and the scores were converted into linear scales. Higher scores indicated the higher quality of life.
Time Frame
Mid-test:end of week 4
Title
The Self-Efficacy for School Physical Activity Questionnaire
Description
Physical activity efficacy scale [the Self-Efficacy for School Physical Activity Questionnaire (SEPAQ)] to assess task related efficacy in the main school activity behavioural.Using the scale, please check the appropriate response (0-100%) for each question.Higher scores indicated the higher self-efficacy level
Time Frame
Mid-test:end of week 4
Title
Parent child relational quality scale
Description
From the perspective of adolescents, this scale includes 29 items and is divided into four dimensions: parent-child intimacy, parent-child conflict, parent-child trust, and parent-child satisfaction to measure the quality of the parent-child relationship. Scoring: This questionnaire adopts a 5-point Likert scale, with 1-5 representing increasing support (1=strongly disagree; 2=Disagree;3=Not necessarily;4=agree; 5=strongly agree).Higher scores indicated the higher parent child relational quality
Time Frame
Mid-test:end of week 4
Title
Parental Support Scale for Children's Physical Exercise
Description
The questionnaire includes 20 items. From the parent's perspective, parents' support for children's physical activity behavior is measured from five dimensions: verbal encouragement, physical activity model, logistical support, behavior encouragement, and physical activity preference. Scoring: This questionnaire adopts a 5-point Likert scale, with 1-5 representing increasing support (1=never; 2=rarely; 3=sometimes; 4=often; 5=always.Higher scores indicated the higher parental support level
Time Frame
Mid-test:end of week 4
Other Pre-specified Outcome Measures:
Title
Physical Activity Questionnaire for Children (PAQ-C)
Description
It is a self-filled and retrospective physical activity level questionnaire for children and adolescents (PAQ-C)(aged 7 to 18). On the one hand, PAQ-C measures the general level of physical activity by scoring (continuous variable) rather than measuring the intensity, frequency, and duration of physical activity, which improves its operational and theoretical feasibility; On the other hand, PAQ-C helps to improve time efficiency and reduce capital costs, making it easy to manage and operate.Likert's 5-level scoring method adopted five numbers of scores from 1(strongly disagree) to 5 (strongly agree) were used, and the scores were converted into linear scales. Higher scores indicated the higher PA level.
Time Frame
Post-test:end of week 8
Title
Pediatric Quality of Life Inventory 4.0 (PedsQL)
Description
The scale is used to assess the quality of life of young adults in the past seven days. The scale included 23 items, which assessed the physical (8 items), social (5 items), school (5 items), and emotional (5 items). Likert's 5-level scoring method adopted five numbers of scores from 0 (never) to 4 (almost always) were used, and the scores were converted into linear scales. Higher scores indicated the higher quality of life.
Time Frame
Post-test:end of week 8
Title
The Self-Efficacy for School Physical Activity Questionnaire
Description
Physical activity efficacy scale [the Self-Efficacy for School Physical Activity Questionnaire (SEPAQ)] to assess task related efficacy in the main school activity behavioural.Using the scale, please check the appropriate response (0-100%) for each question.Higher scores indicated the higher self-efficacy level
Time Frame
Post-test:end of week 8
Title
Parent child relational quality scale
Description
From the perspective of adolescents, this scale includes 29 items and is divided into four dimensions: parent-child intimacy, parent-child conflict, parent-child trust, and parent-child satisfaction to measure the quality of the parent-child relationship. Scoring: This questionnaire adopts a 5-point Likert scale, with 1-5 representing increasing support (1=strongly disagree; 2=Disagree;3=Not necessarily;4=agree; 5=strongly agree).Higher scores indicated the higher parent child relational quality
Time Frame
Post-test:end of week 8
Title
Parental Support Scale for Children's Physical Exercise
Description
The questionnaire includes 20 items. From the parent's perspective, parents' support for children's physical activity behavior is measured from five dimensions: verbal encouragement, physical activity model, logistical support, behavior encouragement, and physical activity preference. Scoring: This questionnaire adopts a 5-point Likert scale, with 1-5 representing increasing support (1=never; 2=rarely; 3=sometimes; 4=often; 5=always.Higher scores indicated the higher parental support level
Time Frame
Post-test:end of week 8

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The family needs to install a television and connect to the Internet The family has never purchased a game console similar to AVG before ensure that at least one parent has enough time to accompany his or her child to complete the experimental task in a week BMI percentile should be more than 85 there are no other sports besides daily physical activities The parents of the subjects agreed with their children to participate in the experiment and were willing to participate with their children. Exclusion Criteria: Clinically diagnosed with mental illness Clinically diagnosed chronic disease Relevant weight loss drugs taken within half a year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiqiang Mai
Phone
+8618639160929
Email
maiyiqiang929@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Geok Soh
Phone
03-97698153
Email
kims@upm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiqiang Mai
Organizational Affiliation
Universiti Putra Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Putra Malaysia
City
Jiaozuo
State/Province
Henan
ZIP/Postal Code
454000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiqiang Mai
Phone
+8618639160929
Email
maiyiqiang929@126.com
First Name & Middle Initial & Last Name & Degree
Fengmeng Qi
Phone
+8617603915127
Email
583135958@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Since this is my doctoral thesis experiment, I don't want to share it until after graduation
Citations:
PubMed Identifier
24256892
Citation
Takeuchi H, Taki Y, Hashizume H, Asano K, Asano M, Sassa Y, Yokota S, Kotozaki Y, Nouchi R, Kawashima R. The impact of television viewing on brain structures: cross-sectional and longitudinal analyses. Cereb Cortex. 2015 May;25(5):1188-97. doi: 10.1093/cercor/bht315. Epub 2013 Nov 20.
Results Reference
result
PubMed Identifier
26918815
Citation
Staiano AE, Marker AM, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL. A randomized controlled trial of dance exergaming for exercise training in overweight and obese adolescent girls. Pediatr Obes. 2017 Apr;12(2):120-128. doi: 10.1111/ijpo.12117. Epub 2016 Feb 26.
Results Reference
result
PubMed Identifier
31367239
Citation
Staiano AE, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL Jr. A 12-week randomized controlled pilot study of dance exergaming in a group: Influence on psychosocial factors in adolescent girls. Cyberpsychology (Brno). 2018;12(2):3. doi: 10.5817/CP2018-2-3.
Results Reference
result

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Effects of Parental Involvement in Exergames Play on Physical and Mental Health on Overweight and Obese Male Adolescent

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