NCT06579495

Brief 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. 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.

Trial Health

35
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 Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 25, 2024

Last Update Submit

August 27, 2024

Conditions

Keywords

Competitive ExergameMental HealthSocial-emotional

Outcome Measures

Primary Outcomes (11)

  • Weight

    Weight is measured using a standard kilogram scale and results are given in kilograms (kg).

    pretest, week 4, week 8

  • Height

    Height is measured using a standard height ruler and results are given in meters(m).

    pretest, week 4, week 8

  • Body Mass Index (BMI)

    Body Mass Index (BMI) is measured using the formula BMI = weight (kg)/height (m)\^2.

    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).

    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 %.

    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.

    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.

    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.

    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.

    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.

    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.

    pretest, week 4, week 8

Study Arms (3)

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.

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.

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.

Other: Children did not engage in any Competitive Exergame play

Interventions

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.

Peer involvement in Two player mode(peer involvement) in Competitive Exergame play

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 play

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 play

Eligibility Criteria

Age12 Years - 14 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • Christison 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.

MeSH Terms

Conditions

Weight LossOverweightObesityPsychological Well-Being

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesPersonal SatisfactionBehavior

Study Officials

  • Chunqing Liu

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

August 25, 2024

First Posted

August 30, 2024

Study Start

September 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

August 30, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

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