- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05769374
Effects of Parental Involvement in Exergames Play on Physical and Mental Health on Overweight and Obese Male Adolescent
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yiqiang Mai
- Phone Number: +8618639160929
- Email: maiyiqiang929@126.com
Study Contact Backup
- Name: Kim Geok Soh
- Phone Number: 03-97698153
- Email: kims@upm.edu.my
Study Locations
-
-
Henan
-
Jiaozuo, Henan, China, 454000
- Recruiting
- Universiti Putra Malaysia
-
Contact:
- Fengmeng Qi
- Phone Number: +8617603915127
- Email: 583135958@qq.com
-
Contact:
- Yiqiang Mai
- Phone Number: +8618639160929
- Email: maiyiqiang929@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Two player mode(parental involvement) in AVG play
the parent involvement group requires one parent to accompany the child to complete the experimental task
|
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
|
Experimental: Single player mode in AVG play
the single-person model and the child need to complete the experimental task under the parent's supervision.
|
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
|
Active Comparator: children did not engage in any AVGs play
children did not engage in any AVGs play nor any other structured school-based PA programs beyond physical education.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Questionnaire for Children (PAQ-C)
Time Frame: Before the experiment
|
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.
|
Before the experiment
|
Pediatric Quality of Life Inventory 4.0 (PedsQL)
Time Frame: Before the experiment
|
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.
|
Before the experiment
|
The Self-Efficacy for School Physical Activity Questionnaire
Time Frame: Before the experiment
|
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
|
Before the experiment
|
Parent child relational quality scale
Time Frame: Before the experiment
|
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 |
Before the experiment
|
Parental Support Scale for Children's Physical Exercise
Time Frame: Before the experiment
|
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 |
Before the experiment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Questionnaire for Children (PAQ-C)
Time Frame: Mid-test:end of week 4
|
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.
|
Mid-test:end of week 4
|
Pediatric Quality of Life Inventory 4.0 (PedsQL)
Time Frame: Mid-test:end of week 4
|
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.
|
Mid-test:end of week 4
|
The Self-Efficacy for School Physical Activity Questionnaire
Time Frame: Mid-test:end of week 4
|
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
|
Mid-test:end of week 4
|
Parent child relational quality scale
Time Frame: Mid-test:end of week 4
|
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 |
Mid-test:end of week 4
|
Parental Support Scale for Children's Physical Exercise
Time Frame: Mid-test:end of week 4
|
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 |
Mid-test:end of week 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Questionnaire for Children (PAQ-C)
Time Frame: Post-test:end of week 8
|
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.
|
Post-test:end of week 8
|
Pediatric Quality of Life Inventory 4.0 (PedsQL)
Time Frame: Post-test:end of week 8
|
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.
|
Post-test:end of week 8
|
The Self-Efficacy for School Physical Activity Questionnaire
Time Frame: Post-test:end of week 8
|
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
|
Post-test:end of week 8
|
Parent child relational quality scale
Time Frame: Post-test:end of week 8
|
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 |
Post-test:end of week 8
|
Parental Support Scale for Children's Physical Exercise
Time Frame: Post-test:end of week 8
|
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 |
Post-test:end of week 8
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yiqiang Mai, Universiti Putra Malaysia
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mai Yiqiang
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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