Weight LossNCT06579495
Effects of Competitive Exergame on Weight Loss, Mental Health, and Social-emotional
A study testing Peer involvement in Two player mode(peer involvement) in Competitive Exergame play, Single player mode in Competitive Exergame play and Children did not engage in any Competitive Exergame play in people with Weight Loss and Mental Health Issue, run by Universiti Putra Malaysia.
Trial summary
Overweight and obesity are prevalent, especially among adolescents. By 2016, over 124 million children and adolescents, comprising 6% of girls and 8% of boys, were classified as obese. Read more about this study
- Who is it for?
- Ages 12 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Mental Health Issue, Overweight and Obesity
- What is being tested?
- Peer involvement in Two player mode(peer involvement) in Competitive Exergame play, Single player mode in Competitive Exergame play and Children did not engage in any Competitive Exergame play
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- The age of the experimental subjects should be 12-14 years old;
- The student had never played AVG before;
- The students' BMI percentile should be more than 85;
- There are no other sports besides daily physical activities;
- The students without physical and/or mental disabilities;
Who cannot join
- Having self-reported physical and/or mental disabilities;
- Having motion sickness reaction when exercising under AVG based condition;
- Relevant weight loss medicine taken within half a year;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Competitive Exergame on Weight Loss, Mental Health, and Social-emotional Among Overweight and Obese Male Adolescents in China
Overweight and obesity are prevalent, especially among adolescents. By 2016, over 124 million children and adolescents, comprising 6% of girls and 8% of boys, were classified as obese. Over the past century, childhood obesity has transitioned from a symbol of prosperity and well-being to being acknowledged as a significant health concern. Furthermore, according to the World Health Organization, it is now considered "one of the most serious challenges of the 21st century." Overweight and obese adolescents have serious problems with weight loss, mental health and social-emotional. A previous study by Lopez identified time constraints and a lack of motivation as hindrances to physical activity, a key component of effective weight loss measures.
In today's society, developed modern technology plays a very important role in the growth of teenagers and in their daily life. Exergame is a new type of video game that allows participants to be more active, stimulating their whole body movement game experience and promoting non-sedentary physical activity. Active Video Games (AVGs) utilize motion-sensing technology to simplify the complex functions typically associated with computer operations. Exergaming is a novel video game that stimulates an active whole-body gaming experience that allow to play multiple players compete or cooperate on a team. Playing against a peer offering both virtual and real social interaction is more likely to sustain engagement, and also promotes higher energy expenditure in an exergame compared to playing alone.
Harnessing adolescents' fascination with video games represents an innovative strategy in the battle against pediatric obesity and sedentary lifestyles. It is especially important to intervene with overweight and obese adolescents using Competitive exergame to become more actively involved in sports, no longer afraid of social interaction, and improve quality of life. Competitive exergame provides a virtual and a real social interaction to improve mental health on overweight and obese adolescents. Therefore, the study will systematically investigate the effects of Competitive Exergame on Weight loss, Mental health,and Social-emotional among overweight and obese male adolescents in China.
Read the detailed description
To assess the effectiveness of Competitive exergame as an intervention, overweight and obese adolescents participating in this study were randomly assigned to three groups (two experimental and one control). This experimental design consists of peer involvement in AVG play and AVG single-player, as well as one control group (children maintained normal daily life without intervention). The sample is 12-14-year-old Chinese overweight and obese male middle school students. The test site is in the school, and the child needs to complete the experimental task under the PE teacher's supervision. The researchers will set up their groups on the WeChat platform, which will be used to contact parents to learn about the subjects' daily diets. The experiment lasted for 8 weeks, with the experimental group conducted three 45-minute interventions per week. The independent variable in this study was the Competitive Exergame intervention, while the dependent variables were weight loss, mental health, and social-emotional. Based on the study design, which involves learning from and summarizing quantitative studies, the dependent variables were measured at three points: pre-test (before the intervention), post-test 1 (4 weeks after the intervention), and post-test 2 (8 weeks after the intervention). The data from these three measurements were collected, organized, and analyzed.
BMI was calculated using a formula, body fat was measured using bioelectrical impedance (BIA), and waist-to-hip ratio was measured using an accurate tape measure. Satisfaction was measured using Multidimensional Students' Life Satisfaction Scale (MSLSS). It should be noted that a 6-point agreement format has been used with middle and high school students. For each item, there are 4 response options ranging from 1 to 6 (1=Strongly Disagree'2=Mostly Disagree, 3=Mildly Disagree'4=Mildly Agree'5=Mostly Agree'6=Strongly Agree). Hence'10 negatively-keyed items are scored so that Strongly Agree= 1, and so forth. Higher scores thus indicate higher levels of life satisfaction throughout the scale. Previous studies have confirmed the Cronbach's alpha is 0.90. Self-confident was measured using Self-Confidence Scale for Chinese Primary and Secondary School (SCS). A 17-item self-confidence scale for primary and secondary school students in China was developed through theoretical construction exploratory and confirmatory factor analysis. The SCS used a 5-point Likert scale ranging from 1 (disagree a lot) to 5 (agree a lot). A higher score indicates a student perceived higher Self-Confidence. The scale has been validated with a Cronbach's alpha of 0.84. Depression was measured using Patient Health Questionnaire (PHQ-9). It comprises 9 diagnostic symptom criteria based on the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) major depressive disorder. Each item has 4 response options ranging from 0 = "not at all" to 3 ="nearly every day" with total scores ranging from 0 to 27. Previous studies have confirmed the Cronbach's alpha is 0.89. Self-efficacy was measured using Physical activity self-efficacy Scales (S-PASESC). The SPASES used a 5-point Likert scale ranging from 1 (disagree a lot) to 5 (agree a lot). A higher score indicates a student perceived higher PA self-efficacy. A higher score indicates a student perceived higher PA self-efficacy. The scale has been validated with a Cronbach's alpha of 0.92. Self-esteem was measured using Self-Esteem Scale (SES). A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. All items are answered using a 4-point Likert scale ranging from strongly agree to strongly disagree. Items 2, 5, 6, 8, 9 are reverse scored. Give "Strongly Disagree" 1 point, "Disagree" 2 points, "Agree" 3 points, and "Strongly Agree" 4 points. The scores for all ten items. Keep scores on a continuous scale. Higher scores indicate higher self-esteem. The scale has been validated with a Cronbach's alpha of 0.88. Social Anxiety was measured using Social Phobia and Anxiety Inventory Form (SPAI-B). The SPAI-B consists of 16 items answered with a 5-point Likert scale ranging from 1 (Never happens) to 5 (Always happens). The total score is 23 to 115, and the higher the score, the more obvious the anxiety symptoms. The scale has been validated with a Cronbach's alpha of 0.92.
Before the training was conducted, training and explanations were provided to all members of the experimental group, which mainly included game mode selection, game login, and explanation of operating procedures. The game consists of 9 sports events. Each game has a single-player mode and a multi-player mode. Each class consists of three parts: Upper and lower body training, Sports games and Aerobic exercise. Players need to choose the mode to exercise. The experiment lasted for 8 weeks, with 45-minute intervention three times a week.
Week 1: Log in to the Nintendo game account registered in advance. Experimental group 1 chose the multiplayer mode and the Experimental group 2 chose the single mode. Each class of Upper and lower body strength training (Bowling) section lasts 10 minutes. The Sports games (Table tennis) section of each lesson lasts 20 minutes, and the Cardio (Fecing) section of each lesson lasts 15 minutes. This week's game level is Beginner.
Week 2: Following the game selections from last week, there is a multiplayer mode for Experimental Group 1 and a single-player mode for Experimental Group 2. This week's game level is Advanced.
Week 3: Experimental group 1 chose the multiplayer mode and the Experimental group 2 chose the single mode. Each class of Upper and lower body strength training (Golf) section lasts 10 minutes. The Sports games (Tennis) section of each lesson lasts 20 minutes, and the Cardio (Cycling) section of each lesson lasts 15 minutes. This week's game level is Beginner.
Week 4: Following the game selections from last week, there is a multiplayer mode for Experimental Group 1 and a single-player mode for Experimental Group 2. This week's game level is Intermediate.
Week 5: Following the game selections from last week, there is a multiplayer mode for Experimental Group 1 and a single-player mode for Experimental Group 2. This week's game level is Advanced.
Week 6: Experimental group 1 chose the multiplayer mode and the Experimental group 2 chose the single mode. Each class of Upper and lower body strength training (Basketball) section lasts 10 minutes. The Sports games (Boxing) section of each lesson lasts 20 minutes, and the Cardio (Dance) section of each lesson lasts 15 minutes. This week's game level is Beginner.
Week 7: Following the game selections from last week, there is a multiplayer mode for Experimental Group 1 and a single-player mode for Experimental Group 2. This week's game level is Intermediate.
Week 8: Following the game selections from last week, there is a multiplayer mode for Experimental Group 1 and a single-player mode for Experimental Group 2. This week's game level is Advanced.
- Conditions
- Weight Loss, Mental Health Issue, Overweight and Obesity
- Being tested
- Peer involvement in Two player mode(peer involvement) in Competitive Exergame play, Single player mode in Competitive Exergame play, Children did not engage in any Competitive Exergame play
- Keywords
- Competitive Exergame, Mental Health, Social-emotional
- Medical subject headings
- Weight Loss, Overweight, Obesity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer involvement in Two player mode(peer involvement) in Competitive Exergame playOther
Device: Nintendo Wii sports competitive versus. The duration of the study was 8 weeks and the frequency was 45 minutes, three times per week. In the first two weeks, three games of bowling, tennis and fencing will be selected for experimentation at the beginner and intermediate levels respectively. In the three weeks from week 3 to week 5, golf, tennis and cycling were selected for the beginner, intermediate and advanced levels of the experiment. In the last three weeks, basketball, boxing and dancing will be selected for experimentation at beginner, intermediate and advanced levels respectively. The control group did not participate in any intervention and maintained daily physical activity behavior.
Single player mode in Competitive Exergame playOther
Device: Nintendo Wii sports competitive versus. The duration of the study was 8 weeks and the frequency was 45 minutes, three times per week. In the first two weeks, three games of bowling, tennis and fencing will be selected for experimentation at the beginner and intermediate levels respectively. In the three weeks from week 3 to week 5, golf, tennis and cycling were selected for the beginner, intermediate and advanced levels of the experiment. In the last three weeks, basketball, boxing and dancing will be selected for experimentation at beginner, intermediate and advanced levels respectively. The control group did not participate in any intervention and maintained daily physical activity behavior.
Children did not engage in any Competitive Exergame playOther
Device: Nintendo Wii sports competitive versus. The duration of the study was 8 weeks and the frequency was 45 minutes, three times per week. In the first two weeks, three games of bowling, tennis and fencing will be selected for experimentation at the beginner and intermediate levels respectively. In the three weeks from week 3 to week 5, golf, tennis and cycling were selected for the beginner, intermediate and advanced levels of the experiment. In the last three weeks, basketball, boxing and dancing will be selected for experimentation at beginner, intermediate and advanced levels respectively. The control group did not participate in any intervention and maintained daily physical activity behavior.
| Study group | Role | What they receive |
|---|---|---|
| Peer involvement in Two player mode(peer involvement) in Competitive Exergame play | Experimental | The peer participation group requires a classmate to accompany the child to complete the experiment task. Receives: Other: Peer involvement in Two player mode(peer involvement) in Competitive Exergame play |
| Single player mode in Competitive Exergame play | Experimental | Single player mode play the single-person model and the child need to complete the experimental task under the teacher's supervision. Receives: Other: Single player mode in Competitive Exergame play |
| Children did not engage in any Competitive Exergame play | Active comparator | Children did not engage in any Competitive Exergame play nor any other structured school-based PA programs beyond physical education, and maintained just for a normal school life. Receives: Other: Children did not engage in any Competitive Exergame play |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight is measured using a standard kilogram scale and results are given in kilograms (kg).
Measured: pretest, week 4, week 8
Height
Height is measured using a standard height ruler and results are given in meters(m).
Measured: pretest, week 4, week 8
Body Mass Index (BMI)
Body Mass Index (BMI) is measured using the formula BMI = weight (kg)/height (m)^2.
Measured: pretest, week 4, week 8
Waist-to-hip ratio
Waist-to-hip ratio is measured using a precise tape measure, with waist and hip measurements expressed in centimeters (cm).
Measured: pretest, week 4, week 8
Body fat
Body fat was measured by a body composition analyzer using bioelectric impedance analysis (BIA), and the results were expressed in %.
Measured: pretest, week 4, week 8
The Multidimensional Students' Life Satisfaction Scale (MSLSS)
The Multidimensional Students' Life Satisfaction Scale (MSLSS) is designed to provide a profile of children's life satisfaction across key domains. It should be noted that a 6-point agreement format has been used with middle and high school students. Higher scores thus indicate higher levels of life satisfaction throughout the scale.
Measured: pretest, week 4, week 8
Self-Confidence Scale for Chinese Primary and Secondary School (SCS)
Self-confidence was measured using Self-Confidence Scale for Chinese Primary and Secondary School (SCS). The SCS used a 5-point Likert scale ranging from 1 (disagree a lot) to 5 (agree a lot). A higher score indicates a student perceived higher Self-Confidence.
Measured: pretest, week 4, week 8
Patient Health Questionnaire (PHQ-9)
A higher score indicates a student perceived higher. Self-Confidence. Depression wsa measured using Patient Health Questionnaire (PHQ-9). It comprises 9 diagnostic symptom criteria based on the Diagnostic and Statistical Manual of Mental Disorders#IV (DSM#IV) major depressive disorder.
Measured: pretest, week 4, week 8
Physical activity self-efficacy Scales (S-PASESC)
Self-efficacy was measured using Physical activity self-efficacy Scales (S-PASESC). The SPASES used a 5-point Likert scale ranging from 1 (disagree a lot) to 5 (agree a lot). A higher score indicates a student perceived higher PA self-efficacy. A higher score indicates a student perceived higher PA self-efficacy.
Measured: pretest, week 4, week 8
Self-Esteem Scale (SES)
Self-Esteem was measured uasing Self-Esteem Scale (SES). A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. All items are answered using a 4-point Likert scale ranging from strongly agree to strongly disagree. The scores for all ten items. Keep scores on a continuous scale. Higher scores indicate higher self-esteem.
Measured: pretest, week 4, week 8
Social Phobia and Anxiety Inventory Form (SPAI-B)
Social Anxiety was measured using Social Phobia and Anxiety Inventory Form (SPAI-B). The SPAI-B consists of 16 items answered with a 5-point Likert scale ranging from 1 (Never happens) to 5 (Always happens). The total score is 23 to 115, and the higher the score, the more obvious the anxiety symptoms.
Measured: pretest, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this experiment, experimental group 1 involved peer participation in a Competitive Exergame; that is, the participants were accompanied by peers to complete the experiment. Experimental group 2 completed the task on their own using the Single-player Competitive Exergame. The control group did not undergo any intervention and simply continued with their normal school routine.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Chunqing, Universiti Putra Malaysia
- Investigators
- Chunqing Liu, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579495
- Sponsor's protocol ID
- Liu Chunqing
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this is my doctoral thesis experiment, I don't want to share it until after graduation.
Publications
Irandoust K, Taheri M, H'mida C, Neto GR, Trabelsi K, Ammar A, Souissi N, Chtourou H, Nikolaidis PT, Rosemann T, Knechtle B. Exergaming and Aquatic Exercises Affect Lung Function and Weight Loss in Obese Children. Int J Sports Med. 2021 Jun;42(6):566-572. doi: 10.1055/a-1289-9307. Epub 2020 Nov 11.
PubMed 33176381Christison AL, Evans TA, Bleess BB, Wang H, Aldag JC, Binns HJ. Exergaming for Health: A Randomized Study of Community-Based Exergaming Curriculum in Pediatric Weight Management. Games Health J. 2016 Dec;5(6):413-421. doi: 10.1089/g4h.2015.0097. Epub 2016 Dec 2.
PubMed 27911621
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Competitive Exergame on Weight Loss, Mental Health, and Social-emotional Among Overweight and Obese Male Adolescents in China
- ClinicalTrials.gov ID
- NCT06579495
- Acronym / sponsor ID
- Liu Chunqing
- Conditions
- Weight Loss, Mental Health Issue, Overweight and Obesity
- Keywords
- Competitive Exergame, Mental Health, Social-emotional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overweight and obesity are prevalent, especially among adolescents. By 2016, over 124 million children and adolescents, comprising 6% of girls and 8% of boys, were classified as obese. Over the past century, childhood obesity has transitioned from a symbol of prosperity and well-being to being acknowledged as a significant health concern. Furthermore, according to the World Health Organization, it is now considered "one of the most serious challenges of the 21st century." Overweight and obese adolescents have serious problems with weight loss, mental health and social-emotional. A previous study by Lopez identified time constraints and a lack of motivation as hindrances to physical activity, a key component of effective weight loss measures.
In today's society, developed modern technology plays a very important role in the growth of teenagers and in their daily life. Exergame is a new type of video game that allows participants to be more active, stimulating their whole body movement game experience and promoting non-sedentary physical activity. Active Video Games (AVGs) utilize motion-sensing technology to simplify the complex functions typically associated with computer operations. Exergaming is a novel video game that stimulates an active whole-body gaming experience that allow to play multiple players compete or cooperate on a team. Playing against a peer offering both virtual and real social interaction is more likely to sustain engagement, and also promotes higher energy expenditure in an exergame compared to playing alone.
Harnessing adolescents' fascination with video games represents an innovative strategy in the battle against pediatric obesity and sedentary lifestyles. It is especially important to intervene with overweight and obese adolescents using Competitive exergame to become more actively involved in sports, no longer afraid of social interaction, and improve quality of life. Competitive exergame provides a virtual and a real social interaction to improve mental health on overweight and obese adolescents. Therefore, the study will systematically investigate the effects of Competitive Exergame on Weight loss, Mental health,and Social-emotional among overweight and obese male adolescents in China.
Detailed description
To assess the effectiveness of Competitive exergame as an intervention, overweight and obese adolescents participating in this study were randomly assigned to three groups (two experimental and one control). This experimental design consists of peer involvement in AVG play and AVG single-player, as well as one control group (children maintained normal daily life without intervention). The sample is 12-14-year-old Chinese overweight and obese male middle school students. The test site is in the school, and the child needs to complete the experimental task under the PE teacher's supervision. The researchers will set up their groups on the WeChat platform, which will be used to contact parents to learn about the subjects' daily diets. The experiment lasted for 8 weeks, with the experimental group conducted three 45-minute interventions per week. The independent variable in this study was the Competitive Exergame intervention, while the dependent variables were weight loss, mental health, and social-emotional. Based on the study design, which involves learning from and summarizing quantitative studies, the dependent variables were measured at three points: pre-test (before the intervention), post-test 1 (4 weeks after the intervention), and post-test 2 (8 weeks after the intervention). The data from these three measurements were collected, organized, and analyzed.
BMI was calculated using a formula, body fat was measured using bioelectrical impedance (BIA), and waist-to-hip ratio was measured using an accurate tape measure. Satisfaction was measured using Multidimensional Students' Life Satisfaction Scale (MSLSS). It should be noted that a 6-point agreement format has been used with middle and high school students. For each item, there are 4 response options ranging from 1 to 6 (1=Strongly Disagree'2=Mostly Disagree, 3=Mildly Disagree'4=Mildly Agree'5=Mostly Agree'6=Strongly Agree). Hence'10 negatively-keyed items are scored so that Strongly Agree= 1, and so forth. Higher scores thus indicate higher levels of life satisfaction throughout the scale. Previous studies have confirmed the Cronbach's alpha is 0.90. Self-confident was measured using Self-Confidence Scale for Chinese Primary and Secondary School (SCS). A 17-item self-confidence scale for primary and secondary school students in China was developed through theoretical construction exploratory and confirmatory factor analysis. The SCS used a 5-point Likert scale ranging from 1 (disagree a lot) to 5 (agree a lot). A higher score indicates a student perceived higher Self-Confidence. The scale has been validated with a Cronbach's alpha of 0.84. Depression was measured using Patient Health Questionnaire (PHQ-9). It comprises 9 diagnostic symptom criteria based on the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) major depressive disorder. Each item has 4 response options ranging from 0 = "not at all" to 3 ="nearly every day" with total scores ranging from 0 to 27. Previous studies have confirmed the Cronbach's alpha is 0.89. Self-efficacy was measured using Physical activity self-efficacy Scales (S-PASESC). The SPASES used a 5-point Likert scale ranging from 1 (disagree a lot) to 5 (agree a lot). A higher score indicates a student perceived higher PA self-efficacy. A higher score indicates a student perceived higher PA self-efficacy. The scale has been validated with a Cronbach's alpha of 0.92. Self-esteem was measured using Self-Esteem Scale (SES). A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. All items are answered using a 4-point Likert scale ranging from strongly agree to strongly disagree. Items 2, 5, 6, 8, 9 are reverse scored. Give "Strongly Disagree" 1 point, "Disagree" 2 points, "Agree" 3 points, and "Strongly Agree" 4 points. The scores for all ten items. Keep scores on a continuous scale. Higher scores indicate higher self-esteem. The scale has been validated with a Cronbach's alpha of 0.88. Social Anxiety was measured using Social Phobia and Anxiety Inventory Form (SPAI-B). The SPAI-B consists of 16 items answered with a 5-point Likert scale ranging from 1 (Never happens) to 5 (Always happens). The total score is 23 to 115, and the higher the score, the more obvious the anxiety symptoms. The scale has been validated with a Cronbach's alpha of 0.92.
Before the training was conducted, training and explanations were provided to all members of the experimental group, which mainly included game mode selection, game login, and explanation of operating procedures. The game consists of 9 sports events. Each game has a single-player mode and a multi-player mode. Each class consists of three parts: Upper and lower body training, Sports games and Aerobic exercise. Players need to choose the mode to exercise. The experiment lasted for 8 weeks, with 45-minute intervention three times a week.
Week 1: Log in to the Nintendo game account registered in advance. Experimental group 1 chose the multiplayer mode and the Experimental group 2 chose the single mode. Each class of Upper and lower body strength training (Bowling) section lasts 10 minutes. The Sports games (Table tennis) section of each lesson lasts 20 minutes, and the Cardio (Fecing) section of each lesson lasts 15 minutes. This week's game level is Beginner.
Week 2: Following the game selections from last week, there is a multiplayer mode for Experimental Group 1 and a single-player mode for Experimental Group 2. This week's game level is Advanced.
Week 3: Experimental group 1 chose the multiplayer mode and the Experimental group 2 chose the single mode. Each class of Upper and lower body strength training (Golf) section lasts 10 minutes. The Sports games (Tennis) section of each lesson lasts 20 minutes, and the Cardio (Cycling) section of each lesson lasts 15 minutes. This week's game level is Beginner.
Week 4: Following the game selections from last week, there is a multiplayer mode for Experimental Group 1 and a single-player mode for Experimental Group 2. This week's game level is Intermediate.
Week 5: Following the game selections from last week, there is a multiplayer mode for Experimental Group 1 and a single-player mode for Experimental Group 2. This week's game level is Advanced.
Week 6: Experimental group 1 chose the multiplayer mode and the Experimental group 2 chose the single mode. Each class of Upper and lower body strength training (Basketball) section lasts 10 minutes. The Sports games (Boxing) section of each lesson lasts 20 minutes, and the Cardio (Dance) section of each lesson lasts 15 minutes. This week's game level is Beginner.
Week 7: Following the game selections from last week, there is a multiplayer mode for Experimental Group 1 and a single-player mode for Experimental Group 2. This week's game level is Intermediate.
Week 8: Following the game selections from last week, there is a multiplayer mode for Experimental Group 1 and a single-player mode for Experimental Group 2. This week's game level is Advanced.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- In this experiment, experimental group 1 involved peer participation in a Competitive Exergame; that is, the participants were accompanied by peers to complete the experiment. Experimental group 2 completed the task on their own using the Single-player Competitive Exergame. The control group did not undergo any intervention and simply continued with their normal school routine.
| Arm | Type | Receives |
|---|---|---|
| Peer involvement in Two player mode(peer involvement) in Competitive Exergame play | Experimental | Other: Peer involvement in Two player mode(peer involvement) in Competitive Exergame playThe peer participation group requires a classmate to accompany the child to complete the experiment task. |
| Single player mode in Competitive Exergame play | Experimental | Other: Single player mode in Competitive Exergame playSingle player mode play the single-person model and the child need to complete the experimental task under the teacher's supervision. |
| Children did not engage in any Competitive Exergame play | Active comparator | Other: Children did not engage in any Competitive Exergame playChildren did not engage in any Competitive Exergame play nor any other structured school-based PA programs beyond physical education, and maintained just for a normal school life. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The age of the experimental subjects should be 12-14 years old;
- The student had never played AVG before;
- The students' BMI percentile should be more than 85;
- There are no other sports besides daily physical activities;
- The students without physical and/or mental disabilities;
Key exclusion criteria (3 listed)
- Having self-reported physical and/or mental disabilities;
- Having motion sickness reaction when exercising under AVG based condition;
- Relevant weight loss medicine taken within half a year;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer involvement in Two player mode(peer involvement) in Competitive Exergame playDevice: Nintendo Wii sports competitive versus. The duration of the study was 8 weeks and the frequency was 45 minutes, three times per week. In the first two weeks, three games of bowling, tennis and fencing will be selected for experimentation at the beginner and intermediate levels respectively. In the three weeks from week 3 to week 5, golf, tennis and cycling were selected for the beginner, intermediate and advanced levels of the experiment. In the last three weeks, basketball, boxing and dancing will be selected for experimentation at beginner, intermediate and advanced levels respectively. The control group did not participate in any intervention and maintained daily physical activity behavior. | Other | Peer involvement in Two player mode(peer involvement) in Competitive Exergame play |
| Single player mode in Competitive Exergame playDevice: Nintendo Wii sports competitive versus. The duration of the study was 8 weeks and the frequency was 45 minutes, three times per week. In the first two weeks, three games of bowling, tennis and fencing will be selected for experimentation at the beginner and intermediate levels respectively. In the three weeks from week 3 to week 5, golf, tennis and cycling were selected for the beginner, intermediate and advanced levels of the experiment. In the last three weeks, basketball, boxing and dancing will be selected for experimentation at beginner, intermediate and advanced levels respectively. The control group did not participate in any intervention and maintained daily physical activity behavior. | Other | Single player mode in Competitive Exergame play |
| Children did not engage in any Competitive Exergame playDevice: Nintendo Wii sports competitive versus. The duration of the study was 8 weeks and the frequency was 45 minutes, three times per week. In the first two weeks, three games of bowling, tennis and fencing will be selected for experimentation at the beginner and intermediate levels respectively. In the three weeks from week 3 to week 5, golf, tennis and cycling were selected for the beginner, intermediate and advanced levels of the experiment. In the last three weeks, basketball, boxing and dancing will be selected for experimentation at beginner, intermediate and advanced levels respectively. The control group did not participate in any intervention and maintained daily physical activity behavior. | Other | Children did not engage in any Competitive Exergame play |
Primary outcome
Weight
Time frame: pretest, week 4, week 8
Weight is measured using a standard kilogram scale and results are given in kilograms (kg).
Height
Time frame: pretest, week 4, week 8
Height is measured using a standard height ruler and results are given in meters(m).
Body Mass Index (BMI)
Time frame: pretest, week 4, week 8
Body Mass Index (BMI) is measured using the formula BMI = weight (kg)/height (m)^2.
Waist-to-hip ratio
Time frame: pretest, week 4, week 8
Waist-to-hip ratio is measured using a precise tape measure, with waist and hip measurements expressed in centimeters (cm).
Body fat
Time frame: pretest, week 4, week 8
Body fat was measured by a body composition analyzer using bioelectric impedance analysis (BIA), and the results were expressed in %.
The Multidimensional Students' Life Satisfaction Scale (MSLSS)
Time frame: pretest, week 4, week 8
The Multidimensional Students' Life Satisfaction Scale (MSLSS) is designed to provide a profile of children's life satisfaction across key domains. It should be noted that a 6-point agreement format has been used with middle and high school students. Higher scores thus indicate higher levels of life satisfaction throughout the scale.
Self-Confidence Scale for Chinese Primary and Secondary School (SCS)
Time frame: pretest, week 4, week 8
Self-confidence was measured using Self-Confidence Scale for Chinese Primary and Secondary School (SCS). The SCS used a 5-point Likert scale ranging from 1 (disagree a lot) to 5 (agree a lot). A higher score indicates a student perceived higher Self-Confidence.
Patient Health Questionnaire (PHQ-9)
Time frame: pretest, week 4, week 8
A higher score indicates a student perceived higher. Self-Confidence. Depression wsa measured using Patient Health Questionnaire (PHQ-9). It comprises 9 diagnostic symptom criteria based on the Diagnostic and Statistical Manual of Mental Disorders#IV (DSM#IV) major depressive disorder.
Physical activity self-efficacy Scales (S-PASESC)
Time frame: pretest, week 4, week 8
Self-efficacy was measured using Physical activity self-efficacy Scales (S-PASESC). The SPASES used a 5-point Likert scale ranging from 1 (disagree a lot) to 5 (agree a lot). A higher score indicates a student perceived higher PA self-efficacy. A higher score indicates a student perceived higher PA self-efficacy.
Self-Esteem Scale (SES)
Time frame: pretest, week 4, week 8
Self-Esteem was measured uasing Self-Esteem Scale (SES). A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. All items are answered using a 4-point Likert scale ranging from strongly agree to strongly disagree. The scores for all ten items. Keep scores on a continuous scale. Higher scores indicate higher self-esteem.
Social Phobia and Anxiety Inventory Form (SPAI-B)
Time frame: pretest, week 4, week 8
Social Anxiety was measured using Social Phobia and Anxiety Inventory Form (SPAI-B). The SPAI-B consists of 16 items answered with a 5-point Likert scale ranging from 1 (Never happens) to 5 (Always happens). The total score is 23 to 115, and the higher the score, the more obvious the anxiety symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Results publication: PubMed 33176381Irandoust K, Taheri M, H'mida C, Neto GR, Trabelsi K, Ammar A, Souissi N, Chtourou H, Nikolaidis PT, Rosemann T, Knechtle B. Exergaming and Aquatic Exercises Affect Lung Function and Weight Loss in Obese Children. Int J Sports Med. 2021 Jun;42(6):566-572. doi: 10.1055/a-1289-9307. Epub 2020 Nov 11.
- Results publication: PubMed 27911621Christison AL, Evans TA, Bleess BB, Wang H, Aldag JC, Binns HJ. Exergaming for Health: A Randomized Study of Community-Based Exergaming Curriculum in Pediatric Weight Management. Games Health J. 2016 Dec;5(6):413-421. doi: 10.1089/g4h.2015.0097. Epub 2016 Dec 2.
- Individual participant dataSharing planned: No. Since this is my doctoral thesis experiment, I don't want to share it until after graduation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunqing Liu principal investigator
Universiti Putra Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing Peer involvement in Two player mode(peer involvement) in Competitive Exergame play, Single player mode in Competitive Exergame play and Children did not engage in any Competitive Exergame play in people with Weight Loss and Mental Health Issue, run by Universiti Putra Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuqning Liu (+8618370774883, gs62555@student.upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: pretest, week 4, week 8). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06579495, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.