NCT05769374

Brief Summary

In recent years, with the rising obesity rate, overweight and obesity have become a hot issue of public health. As a sensitive and special group, teenagers shoulder the heavy responsibility of building the motherland, so their health is also the focus of scholars and experts. As a new type of sports game, active video game(AVG) has been proved by many studies to be able to effectively improve the sedentary behavior of teenagers, and can completely become a substitute for today's popular smart phones. In addition, due to the increase of overweight and obese teenagers, a series of psychological problems, such as anxiety, depression, and low self-esteem, also troubled this group. Some researchers can effectively improve the psychological status of the subjects through the intervention experiment of AVG. However, there are few studies on psychosocial beliefs at present, and the impact of psychosocial variables such as self-efficacy, social support and quality of life on overweight and obese groups is extremely important. Moreover, due to the impact of the COVID-19 epidemic, the relationship between family members will also change, especially the alienation and rigidity of the relationship between children and parents will show a significant growth trend. Therefore, this study mainly takes AVG play with parents' participation as the main intervention means to influence the physical activities, psychosocial beliefs and quality of parent-child relationship of the experimental target.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

February 18, 2023

Last Update Submit

March 13, 2023

Conditions

Keywords

Parental involvementExergamePhysical activityPsychosocial

Outcome Measures

Primary 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.

    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.

    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

    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

    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

    Before the experiment

Secondary Outcomes (5)

  • Physical Activity Questionnaire for Children (PAQ-C)

    Mid-test:end of week 4

  • Pediatric Quality of Life Inventory 4.0 (PedsQL)

    Mid-test:end of week 4

  • The Self-Efficacy for School Physical Activity Questionnaire

    Mid-test:end of week 4

  • Parent child relational quality scale

    Mid-test:end of week 4

  • Parental Support Scale for Children's Physical Exercise

    Mid-test:end of week 4

Other Outcomes (5)

  • Physical Activity Questionnaire for Children (PAQ-C)

    Post-test:end of week 8

  • Pediatric Quality of Life Inventory 4.0 (PedsQL)

    Post-test:end of week 8

  • The Self-Efficacy for School Physical Activity Questionnaire

    Post-test:end of week 8

  • +2 more other outcomes

Study Arms (3)

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

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.

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.

Device: cooperative versus competitive AVG play

Interventions

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

Single player mode in AVG playTwo player mode(parental involvement) in AVG playchildren did not engage in any AVGs play

Eligibility Criteria

Age13 Years - 14 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Clinically diagnosed with mental illness
  • Clinically diagnosed chronic disease
  • Relevant weight loss drugs taken within half a year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Putra Malaysia

Jiaozuo, Henan, 454000, China

RECRUITING

Related Publications (3)

  • 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, 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.

  • 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.

MeSH Terms

Conditions

Sedentary BehaviorOverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yiqiang Mai

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 15, 2023

Study Start

July 22, 2022

Primary Completion

April 10, 2023

Study Completion

June 10, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Since this is my doctoral thesis experiment, I don't want to share it until after graduation

Locations