NCT07586579

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2025

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

June 22, 2025

Last Update Submit

May 7, 2026

Conditions

Keywords

childrenobesityphysical exercise

Outcome Measures

Primary Outcomes (4)

  • Body Fat

    Body fat percentage was measured using TANITA BC-545N bioelectrical impedance analysis.

    Baseline, Month 1, Month 2, Month 3

  • Lean Body Mass

    Lean body mass percentage was measured using TANITA BC-545N bioelectrical impedance analysis.

    Baseline, Month 1, Month 2, Month 3

  • Body Water

    Body water percentage was measured using TANITA BC-545N bioelectrical impedance analysis.

    Baseline, Month 1, Month 2, Month 3

  • Bone mass

    Bone mass percentage was measured using TANITA BC-545N bioelectrical impedance analysis.

    Baseline, Month 1, Month 2, Month 3

Study Arms (2)

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.

Procedure: aerobic exercise

Control group

NO INTERVENTION

Routine gymnastic exercise as part of school activity.

Interventions

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.

Intervention group

Eligibility Criteria

Age8 Years - 12 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsWe studied only male school students to avoid measurement bias, since the body composition differs between male and female.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • Students on special diets and have medical reasons for limiting physical activity were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammadiyah Elementary Schools

Palembang, South Sumatera, Indonesia

Location

Related Publications (2)

  • 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.

    PMID: 32340122BACKGROUND
  • Oktaviani 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.

    PMID: 37749512BACKGROUND

MeSH Terms

Conditions

OverweightObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Pediatric Nutrition

Study Record Dates

First Submitted

June 22, 2025

First Posted

May 14, 2026

Study Start

September 13, 2024

Primary Completion

December 22, 2024

Study Completion

December 27, 2024

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations