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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05769374
Other study ID # Mai Yiqiang
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 22, 2022
Est. completion date June 10, 2023

Study information

Verified date March 2023
Source Universiti Putra Malaysia
Contact Yiqiang Mai
Phone +8618639160929
Email maiyiqiang929@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date June 10, 2023
Est. primary completion date April 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 13 Years to 14 Years
Eligibility 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 Design


Intervention

Device:
cooperative versus competitive AVG play
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

Locations

Country Name City State
China Universiti Putra Malaysia Jiaozuo Henan

Sponsors (1)

Lead Sponsor Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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 F — View 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/ce — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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. Post-test:end of week 8
Other 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. Post-test:end of week 8
Other 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 Post-test:end of week 8
Other 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
Post-test:end of week 8
Other 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
Post-test:end of week 8
Primary 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. Before the experiment
Primary 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. Before the experiment
Primary 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 Before the experiment
Primary 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
Before the experiment
Primary 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
Before the experiment
Secondary 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. Mid-test:end of week 4
Secondary 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. Mid-test:end of week 4
Secondary 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 Mid-test:end of week 4
Secondary 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
Mid-test:end of week 4
Secondary 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
Mid-test:end of week 4
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