PreventionNCT06524908
Study on the Effectiveness of a School-Based Fat Loss Program for Adolescents
A study testing Exercise and dietary calorie restriction in people with Prevention, run by Aiyoudong Children and Youth Sports Health Research Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention
- What is being tested?
- Exercise and dietary calorie restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Passed PAR-Q questionnaire screening
- No professional sports experience
- Able to understand the test
- Voluntarily participate in the entire testing process
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Aiyoudong Children and Youth Sports Health Research Institute
Weifang, Shandong, 261000
About this study
Official title: Study of the Effectiveness of an Exercise Intervention Oriented Toward Fat Loss in 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.
- Conditions
- Prevention
- Being tested
- Exercise and dietary calorie restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and dietary calorie restrictionBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Exercise and dietary calorie restriction intervention group | Experimental | Received a twelve-week comprehensive intervention. The number of participants is 50. Receives: Behavioral: Exercise and dietary calorie restriction |
| control group | No intervention | Normal school life without any intervention. The number of participants is 50. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat percentage (%)
Measured by Inbody, a body composition tester using bioelectrical impedance, in %.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From enrollment to the end of intervention at 12 weeks
Fat mass
Measured by Inbody, a body composition tester using bioelectrical impedance, in kg.
Measured: From enrollment to the end of intervention at 12 weeks
Secondary outcomes (6)
Salivary testosterone
Salivary testosterone levels were measured using radioimmunoassay (RIA) and expressed in picograms per liter (pg/L).
Measured: From enrollment to the end of intervention at 12 weeks
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.
Measured: From enrollment to the end of intervention at 12 weeks
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.
Measured: From enrollment to the end of intervention at 12 weeks
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.
Measured: From enrollment to the end of intervention at 12 weeks
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.
Measured: From enrollment to the end of intervention at 12 weeks
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.
Measured: From enrollment to the end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start10 Sep 2022
- Primary completion10 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aiyoudong Children and Youth Sports Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524908
- Sponsor's protocol ID
- Basic-2334
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of an Exercise Intervention Oriented Toward Fat Loss in Adolescents
- ClinicalTrials.gov ID
- NCT06524908
- Acronym / sponsor ID
- Basic-2334
- Conditions
- Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aiyoudong Children and Youth Sports Health Research InstituteUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and dietary calorie restriction intervention group | Experimental | Behavioral: Exercise and dietary calorie restrictionReceived a twelve-week comprehensive intervention. The number of participants is 50. |
| control group | No intervention | –Normal school life without any intervention. The number of participants is 50. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Passed PAR-Q questionnaire screening
- No professional sports experience
- Able to understand the test
- Voluntarily participate in the entire testing process
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and dietary calorie restrictionThe 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) | Behavioural | Exercise and dietary calorie restriction intervention group |
Primary outcome
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 %.
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.
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).
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.
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.
6 secondary outcomes
Salivary testosterone
Time frame: From enrollment to the end of intervention at 12 weeks
Resilience
Time frame: From enrollment to the end of intervention at 12 weeks
Self-esteem
Time frame: From enrollment to the end of intervention at 12 weeks
Aggression
Time frame: From enrollment to the end of intervention at 12 weeks
Eating Self-efficacy
Time frame: From enrollment to the end of intervention at 12 weeks
Exercise Self-Efficacy
Time frame: From enrollment to the end of intervention at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Derived from this study: PubMed 40799526Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and dietary calorie restriction in people with Prevention, run by Aiyoudong Children and Youth Sports Health Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat percentage (%) (time frame: From enrollment to the end of intervention at 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06524908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.