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Completed

NCT Number: NCT06524908

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

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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Key information

Conditions

Prevention

Age range

13 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aiyoudong Children and Youth Sports Health Research Institute

Weifang, Shandong, 261000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Exercise and dietary calorie restriction

Behavioral

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)

Primary outcomes

  1. Body fat percentage (%)

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

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

  2. Physical fitness

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

    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.

  3. Physical activity

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

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

  4. Fat-free mass

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

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

  5. Fat mass

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

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

Secondary outcomes

  1. Salivary testosterone

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

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

  2. Resilience

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

    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.

  3. Self-esteem

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

    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.

  4. Aggression

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

    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.

  5. Eating Self-efficacy

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

    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.

  6. Exercise Self-Efficacy

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

    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.

Sponsors and collaborators

Lead sponsor

Aiyoudong Children and Youth Sports Health Research Institute

Other

Registry information

Official study title

Study of the Effectiveness of an Exercise Intervention Oriented Toward Fat Loss in Adolescents

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 29, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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