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CompletedNCT06524908Updated Jul 10, 2025

Study on the Effectiveness of a School-Based Fat Loss Program for Adolescents

An interventional study of Exercise and dietary calorie restriction in Prevention, sponsored by Aiyoudong Children and Youth Sports Health Research Institute. Completed at 1 site in China. Open to participants aged 13 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-10.

Sponsored by Aiyoudong Children and Youth Sports Health Research Institute · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Sep 2022, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
13 Years to 15 Years
Sex
All
01

Study 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.

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Conditions studied

  • Prevention
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In context

Lead sponsor

Aiyoudong Children and Youth Sports Health Research Institute is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Exercise and dietary calorie restriction intervention group

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

    Behavioral: Exercise and dietary calorie restriction

  • No intervention
    control group

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

Interventions

  • BehavioralExercise and dietary calorie restriction

    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)

06

What researchers measure

Primary outcomes

  1. Body fat percentage (%)

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

    Time frame: From enrollment to the end of intervention at 12 weeks

  2. 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.

    Time frame: From enrollment to the end of intervention at 12 weeks

  3. Physical activity

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

    Time frame: From enrollment to the end of intervention at 12 weeks

  4. Fat-free mass

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

    Time frame: From enrollment to the end of intervention at 12 weeks

  5. Fat mass

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

    Time frame: From enrollment to the end of intervention at 12 weeks

Secondary outcomes

  1. Salivary testosterone

    Salivary testosterone levels were measured using radioimmunoassay (RIA) and expressed in picograms per liter (pg/L).

    Time frame: From enrollment to the end of intervention at 12 weeks

  2. Resilience

    Connor-Davidson Resilience Scale-10 (CD-RISC-10). The scale consists of 10 items, each of which has a score range of 0-4, and the total score range of the scale is 0-40, with higher scores representing greater resilience.

    Time frame: From enrollment to the end of intervention at 12 weeks

  3. Self-esteem

    The Rosenberg Self-Esteem Scale was used, with a total of 10 items. Scores on the scale range from 10 to 40, with higher scores indicating higher levels of self-esteem and better outcomes.

    Time frame: From enrollment to the end of intervention at 12 weeks

  4. Aggression

    Assessed using the Buss-Perry Aggression Questionnaire with a total score range of 29-145. The higher the score, the more aggressive the individual is in that area and the worse the outcome.

    Time frame: From enrollment to the end of intervention at 12 weeks

  5. Eating Self-efficacy

    Eating Self-Efficacy Scale . The minimum score is 10 and the maximum score is 100. Higher scores indicate greater self-efficacy in eating and better outcomes.

    Time frame: From enrollment to the end of intervention at 12 weeks

  6. Exercise Self-Efficacy

    Exercise Self-Efficacy Scale . The minimum score is 18 and the maximum score is 180. The higher the score, the stronger the self-efficacy in exercise and the better the result.

    Time frame: From enrollment to the end of intervention at 12 weeks

07

Study locations

1 site
  • Aiyoudong Children and Youth Sports Health Research Institute
    Weifang, Shandong 261000, China
08

References and documents

Publications

  • 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. PubMed 40799526 ↗

Study documents

  • Protocol, analysis plan and consent form · Aug 1, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06524908
Lead sponsor
Aiyoudong Children and Youth Sports Health Research Institute
Responsible party
Sponsor
First posted
Jul 29, 2024
Start date
Sep 10, 2022
Primary completion
Dec 10, 2022
Completion
Feb 1, 2023
Last update
Jul 10, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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