Physical InactivityNCT05769374
Effects of Parental Involvement in Exergames Play on Physical and Mental Health on Overweight and Obese Male Adolescent
A study testing cooperative versus competitive AVG play in people with Physical Inactivity and Overweight and Obesity, run by Universiti Putra Malaysia at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 13 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Overweight and Obesity, Psychosocial Problem
- What is being tested?
- cooperative versus competitive AVG play
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2022to 10 Jun 2023
- 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 13 to 14 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Clinically diagnosed with mental illness
- Clinically diagnosed chronic disease
- Relevant weight loss drugs taken within half a year
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Universiti Putra Malaysia
Jiaozuo, Henan, 454000
Yiqiang Mai, +8618639160929, maiyiqiang929@126.com
Fengmeng Qi, +8617603915127, 583135958@qq.com
About this study
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
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.
Read the 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.
- Being tested
- cooperative versus competitive AVG play
- Keywords
- Parental involvement, Exergame, Physical activity, Psychosocial
- Medical subject headings
- Sedentary Behavior, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cooperative versus competitive AVG playDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Two player mode(parental involvement) in AVG play | Experimental | the parent involvement group requires one parent to accompany the child to complete the experimental task Receives: Device: cooperative versus competitive AVG play |
| Single player mode in AVG play | Experimental | the single-person model and the child need to complete the experimental task under the parent's supervision. Receives: Device: cooperative versus competitive AVG play |
| children did not engage in any AVGs play | Active comparator | children did not engage in any AVGs play nor any other structured school-based PA programs beyond physical education. Receives: Device: cooperative versus competitive AVG play |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the experiment
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.
Measured: Before the experiment
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
Measured: Before the experiment
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
Measured: Before the experiment
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
Measured: Before the experiment
Secondary outcomes (5)
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.
Measured: Mid-test:end of week 4
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.
Measured: Mid-test:end of week 4
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
Measured: Mid-test:end of week 4
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
Measured: Mid-test:end of week 4
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
Measured: Mid-test:end of week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start22 Jul 2022
- Primary completion10 Apr 2023 (estimated)
- Study completion10 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies 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, 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
- Quadruple blind
- Who is masked
- Participant, Care provider, 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, Mai Yiqiang, Universiti Putra Malaysia
- Investigators
- Yiqiang Mai, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769374
- Sponsor's protocol ID
- Mai Yiqiang
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2023
- Last updated
- 15 Mar 2023
- 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
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.
PubMed 24256892Staiano 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.
PubMed 26918815Staiano 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.
PubMed 31367239
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05769374
- Acronym / sponsor ID
- Mai Yiqiang
- Keywords
- Parental involvement, Exergame, Physical activity, Psychosocial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 10 Apr 2023 (estimated)
- Study completion
- 10 Jun 2023 (estimated)
- First posted
- 15 Mar 2023 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Two player mode(parental involvement) in AVG play | Experimental | Device: cooperative versus competitive AVG playthe parent involvement group requires one parent to accompany the child to complete the experimental task |
| Single player mode in AVG play | Experimental | Device: cooperative versus competitive AVG playthe 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 | Active comparator | Device: cooperative versus competitive AVG playchildren did not engage in any AVGs play nor any other structured school-based PA programs beyond physical education. |
Who may qualify
- Ages
- 13 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Clinically diagnosed with mental illness
- Clinically diagnosed chronic disease
- Relevant weight loss drugs 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 |
|---|---|---|
| cooperative versus competitive AVG playThe 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 | Device | Single player mode in AVG play, Two player mode(parental involvement) in AVG play, children did not engage in any AVGs play |
Primary outcome
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.
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.
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
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
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
5 secondary outcomes
Physical Activity Questionnaire for Children (PAQ-C)
Time frame: Mid-test:end of week 4
Pediatric Quality of Life Inventory 4.0 (PedsQL)
Time frame: Mid-test:end of week 4
The Self-Efficacy for School Physical Activity Questionnaire
Time frame: Mid-test:end of week 4
Parent child relational quality scale
Time frame: Mid-test:end of week 4
Parental Support Scale for Children's Physical Exercise
Time frame: Mid-test:end of week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Results publication: PubMed 24256892Takeuchi 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 publication: PubMed 26918815Staiano 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 publication: PubMed 31367239Staiano 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.
- 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.
Yiqiang Mai principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cooperative versus competitive AVG play in people with Physical Inactivity and Overweight and Obesity, run by Universiti Putra Malaysia at 1 site in China.
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 6 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yiqiang Mai (+8618639160929, maiyiqiang929@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Questionnaire for Children (PAQ-C) (time frame: Before the experiment). The study lists 5 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 NCT05769374, which also lists 3 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 15 Mar 2023.