NCT06510920

Brief Summary

The goal of this clinical trial is to learn if aerobic exercise improves executive functioning in obese children. It will also understand the effects of aerobic exercise on executive functioning in obese children. The main questions it aims to answer are:

  1. 1.What are the levels of executive functioning(inhibitory function, working memory, and cognitive flexibility) in normal-weight and obese children aged 8-10 years?
  2. 2.What are the differences on executive function before and after aerobic exercise intervention among obese children?
  3. 3.Do factors of health, gender and ages influence students' executive functioning (inhibitory function, working memory, and cognitive flexibility)? Researchers will compare the aerobic exercise intervention group with the no-aerobic exercise group in terms of executive function to see if and how much aerobic exercise has an effect on executive function.

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
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

June 27, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

June 27, 2024

Last Update Submit

July 18, 2024

Conditions

Keywords

Executive functionObese ChildrenAerobic ExerciseMental health

Outcome Measures

Primary Outcomes (4)

  • Pre-test: executive function in normal weight children

    Three computer programs will be used to measure executive function:1.Flanker task paradigm to measure inhibition. This test computer recorded reaction durations in milliseconds, and the test score will be calculated as the average reaction durations of the conflict and non-conflict scenarios minus.2.N-Back task paradigm to measure working memory. This test computer records the reaction time in milliseconds, and the test score is the average reaction time.3.More-odd shifting task paradigm to measure cognitive flexibility. This test computer records the reaction time in milliseconds, and the test score is the subtraction of the average reaction time of the switching condition and the non-switching condition. For each of the three tests, the computer returns Units on a Scale 0 to 1 (0= error, 1= correct) to calculate the correct rate.

    Baseline and week 1

  • Pre-test: executive function in obese children

    Three computer programs will be used to measure executive function:1.Flanker task paradigm to measure inhibition. This test computer recorded reaction durations in milliseconds, and the test score will be calculated as the average reaction durations of the conflict and non-conflict scenarios minus.2.N-Back task paradigm to measure working memory. This test computer records the reaction time in milliseconds, and the test score is the average reaction time.3.More-odd shifting task paradigm to measure cognitive flexibility. This test computer records the reaction time in milliseconds, and the test score is the subtraction of the average reaction time of the switching condition and the non-switching condition. For each of the three tests, the computer returns Units on a Scale 0 to 1 (0= error, 1= correct) to calculate the correct rate.

    Baseline and week 1

  • After 12 weeks of executive function level of obese children

    Three computer programs will be used to measure executive function:1.Flanker task paradigm to measure inhibition. This test computer recorded reaction durations in milliseconds, and the test score will be calculated as the average reaction durations of the conflict and non-conflict scenarios minus.2.N-Back task paradigm to measure working memory. This test computer records the reaction time in milliseconds, and the test score is the average reaction time.3.More-odd shifting task paradigm to measure cognitive flexibility. This test computer records the reaction time in milliseconds, and the test score is the subtraction of the average reaction time of the switching condition and the non-switching condition. For each of the three tests, the computer returns Units on a Scale 0 to 1 (0= error, 1= correct) to calculate the correct rate.

    week 12

  • After 12 weeks in the control group executive function level of obese children

    Three computer programs will be used to measure executive function:1.Flanker task paradigm to measure inhibition. This test computer recorded reaction durations in milliseconds, and the test score will be calculated as the average reaction durations of the conflict and non-conflict scenarios minus.2.N-Back task paradigm to measure working memory. This test computer records the reaction time in milliseconds, and the test score is the average reaction time.3.More-odd shifting task paradigm to measure cognitive flexibility. This test computer records the reaction time in milliseconds, and the test score is the subtraction of the average reaction time of the switching condition and the non-switching condition. For each of the three tests, the computer returns Units on a Scale 0 to 1 (0= error, 1= correct) to calculate the correct rate.

    week 12

Study Arms (2)

Obese children aerobic exercise intervention group

EXPERIMENTAL

Aerobic exercise intervention on children obesity in the experimental group, the form of aerobic exercise for football and volleyball training, strength control in moderate intensity, time 1 hour, twice a week.

Behavioral: Aerobic exercise

Obese children of control group

NO INTERVENTION

Control group in obese children will be conducted in normal school physical education, in addition to no other exercise intervention.

Interventions

The mixed design scheme of football and volleyball sports technology and competition will be adopted.aerobic exercise intensity will be moderate-intensity aerobic exercise load , and the intervention time was 12 weeks, 60 minutes each time, twice a week. The main preparation activities were jogging and special preparation activities (10 minutes), and the main part was technical teaching combined with competition (60 minutes).The end part is mostly jogging and stretching (10 minutes). Two subjects in each group were selected to wear Decathlon Bluetooth heart rate band, and the exercise intensity was controlled by detecting the heart rate of the subjects.

Obese children aerobic exercise intervention group

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age: Obese children aged 8-10 years.
  • The body weight was obese or above.
  • There was no history of other concomitant diseases related to obesity,Children with simple obesity.
  • Normal blood pressure.
  • The International Physical Activity Scale (IPAQ, Chinese version) measured participants 'physical activity in the past 7 days, with internal consistency reliability r = 0.927(Qiu NN, 2004).
  • The physical condition Safety questionnaire (PAR-Q) was used to ensure that the exercise in thistest could be completed safely(Appendix2).
  • Uncorrected or corrected visual acuity was normal.

You may not qualify if:

  • In the process of the experiment, it is necessary to participate in other forms of intervention experiments. If the members of the experimental group or the control group are engaged in regular exercise or planned training, they need to be excluded from the experiment.
  • If the members of the experimental group are absent from work for more than1 week, the samples will be deemed to fall off. If the members of the experimental group and the control group fail to participate in any of the data collection on time, they will be excluded.
  • Before and after the experiment, the members of the experimental group or the control group who limited their movement due to sprain and other reasons were excluded.They were randomly divided into experimental group and control group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinan Tangye primary School

Jinan, Shandong, 250100, China

Location

MeSH Terms

Conditions

Pediatric ObesityPsychological Well-Being

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Borhannudin Bin Abdullah, Lecturer

    Faculty of educational studies,,Universiti Putra Malaysia

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 19, 2024

Study Start

August 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 30, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations