NCT07826624

Brief Summary

This randomized controlled study evaluated the effects of a 4-week Brain Breaks® exercise video intervention on physical activity and Transtheoretical Model-related psychosocial factors among overweight and obese children and adolescents in China. Participants were randomly assigned to an intervention group or a control group. The intervention group participated in short, video-based physical activity sessions during school breaks, while the control group did not receive the Brain Breaks intervention. Outcomes included physical activity participation, stage of exercise behavior change, exercise self-efficacy, perceived benefits of exercise, and perceived barriers to exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2022

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

29 days

First QC Date

September 10, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

Brain BreaksExercise VideoPhysical ActivityTranstheoretical ModelStage of ChangeExercise Self-EfficacyPerceived Benefits of ExercisePerceived Barriers to ExerciseSchool-Based InterventionChildren and Adolescents

Outcome Measures

Primary Outcomes (5)

  • Change in Total Physical Activity Measured by the Chinese Version of the International Physical Activity Questionnaire

    Physical activity was assessed using the 7-item Chinese version of the International Physical Activity Questionnaire (IPAQ-C), which assesses physical activity intensity and sitting time during the previous 7 days. Total physical activity was expressed as metabolic equivalent task minutes per week (MET-min/week). Higher values indicate a greater amount of physical activity. Change from baseline to Week 4 was evaluated between the intervention and control groups.

    Baseline and Week 4

  • Change in Stage of Exercise Behavior Change

    Stage of exercise behavior change was assessed according to the Transtheoretical Model. Participants were classified into one of five stages: precontemplation, contemplation, preparation, action, or maintenance. Changes in stage of exercise behavior from baseline to the end of the 4-week intervention were evaluated between groups.

    Baseline and Week 4

  • Change in Exercise Self-Efficacy Measured by the Chinese Version of the Exercise Self-Efficacy Scale

    xercise self-efficacy was assessed using the 18-item Chinese version of the Exercise Self-Efficacy Scale. Each item is rated on a 5-point Likert scale from 1 (not at all confident) to 5 (completely confident). The mean score ranges from 1 to 5, with higher scores indicating greater exercise self-efficacy. Change from baseline to Week 4 was evaluated between the intervention and control groups.

    Baseline and Week 4

  • Change in Perceived Benefits of Exercise Measured by the Chinese Version of the Decisional Balance Scale

    Perceived benefits of exercise were assessed using the Benefits subscale of the 10-item Chinese version of the Decisional Balance Scale. The Benefits subscale consists of 5 items rated on a 5-point scale. The mean subscale score ranges from 1 to 5, with higher scores indicating greater perceived benefits of exercise. Change from baseline to Week 4 was evaluated between the intervention and control groups.

    Baseline and Week 4

  • Change in Perceived Barriers to Exercise Measured by the Chinese Version of the Decisional Balance Scale

    Perceived barriers to exercise were assessed using the Barriers subscale of the 10-item Chinese version of the Decisional Balance Scale. The Barriers subscale consists of 5 items rated on a 5-point scale. The mean subscale score ranges from 1 to 5, with higher scores indicating greater perceived barriers to exercise and therefore a less favorable outcome. Change from baseline to Week 4 was evaluated between the intervention and control groups.

    Baseline and Week 4

Study Arms (2)

Brain Breaks Exercise Video Intervention

EXPERIMENTAL

Participants in this arm received a 4-week Brain Breaks® exercise video intervention. The intervention consisted of approximately 10 minutes of moderate-to-high-intensity video-guided physical activity during school breaks each day. Participants followed short exercise video segments designed to increase physical activity and support exercise behavior change.

Behavioral: Video-Guided Physical Activity Program

Control

NO INTERVENTION

Participants in this arm did not receive the Brain Breaks® exercise video intervention during the study period and continued their usual school activities.

Interventions

Participants assigned to the intervention group received a 4-week video-guided physical activity program using Brain Breaks exercise videos. The intervention consisted of approximately 10 minutes of moderate-to-high-intensity physical activity during school breaks each day. Participants followed short exercise video segments designed to increase physical activity participation and support exercise behavior change. The intervention was delivered in the school setting during the study period.

Brain Breaks Exercise Video Intervention

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Chinese children and adolescents aged 9 to 15 years.
  • Body mass index (BMI) meeting the Chinese criteria for overweight or obesity.
  • Able to complete the study questionnaires.
  • Voluntary participation with informed consent.

You may not qualify if:

  • Unable to participate in physical activity according to the Physical Activity Readiness Questionnaire (PAR-Q).
  • Physical injury or medical condition preventing participation in physical activity.
  • Unwilling to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangxin District No. 7 Primary School

Shangrao, Jiangxi, 334100, China

Location

MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm, parallel-group randomized controlled trial. Eligible participants were randomly assigned to a 4-week Brain Breaks® exercise video intervention group or a control group. Randomization was stratified by age and sex.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 17, 2026

Study Start

May 9, 2022

Primary Completion

June 7, 2022

Study Completion

June 7, 2022

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) underlying the results reported in the publication will be shared. The shared data may include participant-level demographic information, physical activity measures, and Transtheoretical Model-related psychosocial measures. A data dictionary will also be made available.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning within 6 months after publication of the study results. The duration of data availability has not been prespecified.
Access Criteria
Access will be considered for qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the study investigators. Data will be shared only for approved research purposes and after appropriate data-use conditions have been agreed upon. Only de-identified data will be provided.

Locations