NCT06524908

Brief Summary

The students were divided into an intervention group and a control group. The intervention group attended fat loss exercise classes three times a week and the parents cooperated with us in dietary monitoring and control. Before and after the intervention, questionnaires were completed, physical fitness and body composition were measured, and physical activity measurement bracelets were worn for 4 days. In this study, it is possible to know the mental health state, physical activity habits, body composition and physical fitness of adolescents.

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 Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

June 27, 2024

Last Update Submit

July 9, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Body fat percentage (%)

    Measured by Inbody, a body composition tester using bioelectrical impedance, in %.

    From enrollment to the end of intervention at 12 weeks

  • Physical fitness

    Measured using China National Standards for Students' Physical Health (2014 revision), with a minimum value of 0 and a maximum value of 100, higher scores respond to better fitness.

    From enrollment to the end of intervention at 12 weeks

  • Physical activity

    Physical activity (PA) was measured using Actigraph GT3X+ accelerometers, with data expressed as minutes per day (min/day).

    From enrollment to the end of intervention at 12 weeks

  • Fat-free mass

    Measured by Inbody, a body composition tester using bioelectrical impedance, in kg.

    From enrollment to the end of intervention at 12 weeks

  • Fat mass

    Measured by Inbody, a body composition tester using bioelectrical impedance, in kg.

    From enrollment to the end of intervention at 12 weeks

Secondary Outcomes (6)

  • Salivary testosterone

    From enrollment to the end of intervention at 12 weeks

  • Resilience

    From enrollment to the end of intervention at 12 weeks

  • Self-esteem

    From enrollment to the end of intervention at 12 weeks

  • Aggression

    From enrollment to the end of intervention at 12 weeks

  • Eating Self-efficacy

    From enrollment to the end of intervention at 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Exercise and dietary calorie restriction intervention group

EXPERIMENTAL

Received a twelve-week comprehensive intervention. The number of participants is 50.

Behavioral: Exercise and dietary calorie restriction

control group

NO INTERVENTION

Normal school life without any intervention. The number of participants is 50.

Interventions

The intervention group received an exercise intervention three times a week (resistance exercise from 4:30-5:00 p.m. and aerobic exercise from 5:00-5:30 p.m.), and a caloric restriction intervention (guided semi-libre diet with caloric intake restricted to 75% of overall consumption, with parents keeping track of calories and food groups and receiving regular check-ups)

Exercise and dietary calorie restriction intervention group

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Passed PAR-Q questionnaire screening
  • No professional sports experience
  • Able to understand the test
  • Voluntarily participate in the entire testing process

You may not qualify if:

  • Serious organic pathology of the heart, brain, lungs, kidneys, and locomotor system
  • Taking medication for a chronic condition
  • Have history of psychiatric disorders
  • Inability to complete follow-up visits or poor adherence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aiyoudong Children and Youth Sports Health Research Institute

Weifang, Shandong, 261000, China

Location

Related Publications (1)

  • Zhang X, Pan X, Liu B, Gao Y, Jiang L, Chen X, Zhao D, Wang Y, Hu H, Zhao X, Lu J, Suzuki K, Zhang Y. Causal insights into the school-family-research integrated health promotion program for overweight and obesity: the independent role of moderate-to-vigorous physical activity in body fat reduction, undermined by psychological factors. Front Nutr. 2025 Jul 29;12:1577319. doi: 10.3389/fnut.2025.1577319. eCollection 2025.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 29, 2024

Study Start

September 10, 2022

Primary Completion

December 10, 2022

Study Completion

February 1, 2023

Last Updated

July 10, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations