Overweight and ObesityNCT07586579
Aerobic Exercise and Body Composition in Overweight and Obese Boys.
A study testing aerobic exercise in people with Overweight and Obesity and Body Composition, run by Universitas Sriwijaya at 1 site in Indonesia.
Trial summary
Overweight and obesity are unhealthy fat accumulations. children aged 2-18 are deemed overweight if their body mass index (BMI)/Age is ≥ 85th - <95th percentile and obese if >95th percentile. BMI measures obesity but not body fat. Lean and fat mass are not distinguished by BMI. Read more about this study
- Who is it for?
- Ages 8 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Body Composition, Body Fat
- What is being tested?
- aerobic exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Sep 2024to 27 Dec 2024
- 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 8 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- The inclusion criteria were boys, overweight or obese, aged 8-12 years, and consents were given by their parents.
Who cannot join
- Students on special diets and have medical reasons for limiting physical activity were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Aerobic Exercise on Body Composition in Overweight and Obese Boys Aged 8-12 Years.
Overweight and obesity are unhealthy fat accumulations. children aged 2-18 are deemed overweight if their body mass index (BMI)/Age is ≥ 85th - <95th percentile and obese if >95th percentile. BMI measures obesity but not body fat. Lean and fat mass are not distinguished by BMI. Body composition includes total fat, fat-free mass, bone mineral, and water. Obese children have more body fat, lean body mass, bone mineral, and body water but lower lean body mass. aerobic physical exercise changes the body composition of children with overweight and obesity, but research on the effect of aerobic exercise on all body composition variables in Indonesia has never been done, so researchers will investigate its effects.
- Conditions
- Overweight and Obesity, Body Composition, Body Fat, Lean Body Mass, Body Water, Bone Mass
- Being tested
- aerobic exercise
- Keywords
- children, obesity, physical exercise
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseProcedure or surgery
Intervention group received a series of aerobic exercises led by licensed instructors which consisted of three exercises per week (on Tuesday, Thursday, and Friday) for 30 minutes each (from 7-7.30 A.M.). Total number of aerobic exercise was 36 sessions that completed in three consecutive months. Participants who missed one training session would be replaced on another day. Meanwhile, control group did not received the exercise programme, but they could have routine gymnastic exercise once a week as part of school activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group received a series of aerobic exercises led by licensed instructors which consisted of three exercises per week (on Tuesday, Thursday, and Friday) for 30 minutes each (from 7-7.30 A.M.). Total number of aerobic exercise was 36 sessions that completed in three consecutive months. Participants who missed one training session would be replaced on another day. Receives: Procedure: aerobic exercise |
| Control group | No intervention | Routine gymnastic exercise as part of school activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat
Body fat percentage was measured using TANITA BC-545N bioelectrical impedance analysis.
Measured: Baseline, Month 1, Month 2, Month 3
Lean Body Mass
Lean body mass percentage was measured using TANITA BC-545N bioelectrical impedance analysis.
Measured: Baseline, Month 1, Month 2, Month 3
Body Water
Body water percentage was measured using TANITA BC-545N bioelectrical impedance analysis.
Measured: Baseline, Month 1, Month 2, Month 3
Bone mass
Bone mass percentage was measured using TANITA BC-545N bioelectrical impedance analysis.
Measured: Baseline, Month 1, Month 2, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start13 Sep 2024
- Primary completion22 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moretta Damayanti Fauzi, MD, Universitas Sriwijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586579
- Sponsor's protocol ID
- Sriwijaya University
- Other IDs
- 070/0886/DISDIK/2024
- Status last verified
- May 2026
- First submitted
- 22 Jun 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wyszynska J, Matlosz P, Szybisty A, Lenik P, Deren K, Mazur A, Herbert J. Obesity and Body Composition in Preschool Children with Different Levels of Actigraphy-Derived Physical Activity-A Cross-Sectional Study. J Clin Med. 2020 Apr 23;9(4):1210. doi: 10.3390/jcm9041210.
PubMed 32340122Oktaviani S, Mizutani M, Nishide R, Tanimura S. Factors associated with overweight/obesity of children aged 6-12 years in Indonesia. BMC Pediatr. 2023 Sep 25;23(1):484. doi: 10.1186/s12887-023-04321-6.
PubMed 37749512
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aerobic Exercise on Body Composition in Overweight and Obese Boys Aged 8-12 Years.
- ClinicalTrials.gov ID
- NCT07586579
- Acronym / sponsor ID
- Sriwijaya University
- Conditions
- Overweight and Obesity, Body Composition, Body Fat, Lean Body Mass, Body Water, Bone Mass
- Keywords
- children, obesity, physical exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 14 May 2026 (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.
Overweight and obesity are unhealthy fat accumulations. children aged 2-18 are deemed overweight if their body mass index (BMI)/Age is ≥ 85th - <95th percentile and obese if >95th percentile. BMI measures obesity but not body fat. Lean and fat mass are not distinguished by BMI. Body composition includes total fat, fat-free mass, bone mineral, and water. Obese children have more body fat, lean body mass, bone mineral, and body water but lower lean body mass. aerobic physical exercise changes the body composition of children with overweight and obesity, but research on the effect of aerobic exercise on all body composition variables in Indonesia has never been done, so researchers will investigate its effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: aerobic exerciseIntervention group received a series of aerobic exercises led by licensed instructors which consisted of three exercises per week (on Tuesday, Thursday, and Friday) for 30 minutes each (from 7-7.30 A.M.). Total number of aerobic exercise was 36 sessions that completed in three consecutive months. Participants who missed one training session would be replaced on another day. |
| Control group | No intervention | –Routine gymnastic exercise as part of school activity. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The inclusion criteria were boys, overweight or obese, aged 8-12 years, and consents were given by their parents.
Key exclusion criteria (1 listed)
- Students on special diets and have medical reasons for limiting physical activity were excluded
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 |
|---|---|---|
| aerobic exerciseIntervention group received a series of aerobic exercises led by licensed instructors which consisted of three exercises per week (on Tuesday, Thursday, and Friday) for 30 minutes each (from 7-7.30 A.M.). Total number of aerobic exercise was 36 sessions that completed in three consecutive months. Participants who missed one training session would be replaced on another day. Meanwhile, control group did not received the exercise programme, but they could have routine gymnastic exercise once a week as part of school activity. | Procedure or surgery | Intervention group |
Primary outcome
Body Fat
Time frame: Baseline, Month 1, Month 2, Month 3
Body fat percentage was measured using TANITA BC-545N bioelectrical impedance analysis.
Lean Body Mass
Time frame: Baseline, Month 1, Month 2, Month 3
Lean body mass percentage was measured using TANITA BC-545N bioelectrical impedance analysis.
Body Water
Time frame: Baseline, Month 1, Month 2, Month 3
Body water percentage was measured using TANITA BC-545N bioelectrical impedance analysis.
Bone mass
Time frame: Baseline, Month 1, Month 2, Month 3
Bone mass percentage was measured using TANITA BC-545N bioelectrical impedance analysis.
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 14 May 2026.
- Background: PubMed 32340122Wyszynska J, Matlosz P, Szybisty A, Lenik P, Deren K, Mazur A, Herbert J. Obesity and Body Composition in Preschool Children with Different Levels of Actigraphy-Derived Physical Activity-A Cross-Sectional Study. J Clin Med. 2020 Apr 23;9(4):1210. doi: 10.3390/jcm9041210.
- Background: PubMed 37749512Oktaviani S, Mizutani M, Nishide R, Tanimura S. Factors associated with overweight/obesity of children aged 6-12 years in Indonesia. BMC Pediatr. 2023 Sep 25;23(1):484. doi: 10.1186/s12887-023-04321-6.
- Individual participant dataSharing planned: Undecided
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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 aerobic exercise in people with Overweight and Obesity and Body Composition, run by Universitas Sriwijaya at 1 site in Indonesia.
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 1 inclusion and 1 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 14 May 2026. 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 Indonesia. 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 (time frame: Baseline, Month 1, Month 2, Month 3). The study lists 4 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 NCT07586579, which also lists 2 linked publications.
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 14 May 2026.