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NCT Number: NCT07008326

Comparing HICT and MICT for Health Improvements in Overweight Young Adults

The increasing prevalence of overweight and obesity is becoming a concern worldwide as it is associated with the increased prevalence of non-communicable diseases. One of the main reasons for this problem is that more adults did not fulfill the weekly physical activity recommendations, with the lack of time and motivation as the main factor. This study aims to compare the effectiveness of a high-intensity circuit training program and the more familiar moderate-intensity continuous training in improving body composition, cardiorespiratory fitness, lipid profile, oxidative stress, and inflammatory markers in young adult males. At the same time, it also explores its adherence through its enjoyment scale and gradual changes in supervision. This experimental study compares pre- and post-tests in the two groups. 3-days food records and 7-days physical activity will be measured monthly as the confounding factors.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

  • Participants will be recruited consecutively via online forms distributed throughout universities and networks across Jakarta and its surrounding area. Interested individuals will go through early screening. Eligible candidates will then complete an initial assessment at the research site.
  • Research assistants will use standard operational procedures for each assessment. The training for research assistants will be done before data collection. One group of research assistants are responsible for main outcome data collection. The researcher is responsible for data analysis. Continuous evaluations will be done weekly to improve the research process.
  • Sample size is measured from the 6-research outcomes using the sample size calculation formula for evaluating the mean difference between two variables in repeated measurements.
  • Eligible candidates who passed the initial assessment will be randomly divided into HICT (intervention) and MICT (control). The 12-week exercise program in both groups will change gradually in volume, intensity, and supervision. Both volume and intensity will be increased according to heart rate targets. Supervision will decrease gradually from fully supervised in the first 4 weeks, partially supervised in the second 4 weeks, and no supervision in the third 4 weeks.
  • Data will be collected and electronically recorded during each training session at the research site by the researcher and research assistants. This data includes time, heart rate, blood pressure, rating of perceived exertion (Borg Scale), training intensity, weight used, and enjoyment (PACES).
  • Subjects are encouraged to report any problem during intervention via online messaging or during on-site sessions to the research assistants. The reports will be documented in a separate form. The research assistant leading the data collection will ensure that no data is missing by performing daily checking.
  • Data collection for the main outcomes will be done by a different group of research assistants and will be masked from the intervention groupings.
  • Data analysis will be done using SPSS 26.0 by the researcher. The analysis will be started after baseline measurements are completed. We will present all normally distributed numeric data as mean and standard deviations and non-normally distributed numeric data as median and minimum-maximum range. Bivariate analysis of normally distributed data will be done using repeated 2-way ANOVA test or mixed linear model in case of many dropouts. If data is not distributed normally, the Friedman test will be used. Any missing data will be stated and completed immediately. Close supervision for each subject will be done by research assistance to ensure all necessary reports are collected and analysed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Overweight (BMI 23-24.9 kg/m2)
  • Physically inactive in the last 6 months before the study (<150 minutes of moderate-intensity activity and <75 minutes of high-intensity activity)
  • Willing to participate in exercise program for 12 weeks
  • No other exercise program during the study period

Exclusion criteria

  • Smoking
  • Medical comorbidities (diabetes mellitus, hypertension, cardiovascular disease, asthma, dyslipidaemia, epilepsy)
  • History of musculoskeletal injuries or health problems related to exercise in the last 1 year

Dropout Criteria

  • Resigning
  • Not participating in the endline assessment
  • Not participating in the exercise program for 2 consecutive weeks
  • Experiencing injury or health problems that led to the inability to participate in the program for 2 consecutive weeks

Treatment and study plan

High Intensity Circuit Training

Behavioral

HICT: 3x/week high intensity circuit training for 12 weeks

Moderate Intensity Continuous Training

Behavioral

3x/week moderate intensity continuous training for 12 weeks

Primary outcomes

  1. Body Mass Index

    Time frame: Week 0, 4, 8, 12

    Weight and Height will be combined to report Body Mass Index in kg/m^2

  2. Body Fat Percentage

    Time frame: Week 0, 4, 8, 12

    The total percentage of body fat mass measured by BIA Tanita MC-780 in %

  3. Muscle Mass

    Time frame: Week 0, 4, 8, 12

    Muscle mass measured by BIA Tanita MC-780 in kilograms

  4. Visceral Fat Mass

    Time frame: Week 0, 4, 8, 12

    Visceral fat mass measured by BIA Tanita MC-780 in kilograms

  5. Waist Circumference

    Time frame: Week 0, 4, 8, 12

    Waist circumference measured in centimeters

  6. Cardiorespiratory Fitness

    Time frame: Week 0, 12

    VO2Max or VO2peak depends on the feasibility. The cardiac output (mL/min) and body weight (kg) will be combined in mL/kg. min

  7. Total Cholesterol

    Time frame: Week 0, 12

    Total cholesterol in blood measured in mg/dL

  8. High-Density Lipoprotein (HDL)

    Time frame: Week 0, 12

    HDL concentration in blood measured in mg/dL

  9. Low-Density Lipoprotein (LDL)

    Time frame: Week 0, 12

    LDL concentration in blood measured in mg/dL

  10. Triglyceride

    Time frame: Week 0, 12

    Triglyceride concentration in blood measured in mg/dL

  11. Superoxide dismutase

    Time frame: Week 0, 12

    Superoxide dismutase concentration in blood from whole blood sample measured in U/mL

  12. Malondialdehyde

    Time frame: Week 0, 12

    Malondialdehyde concentration in blood from whole blood samples measured in micromolar

  13. Tumor Necrosis Factor-alpha

    Time frame: Week 0, 12

    Tumor Necrosis Factor-alpha concentration in blood measured in pg/mL

  14. Interleukin-6

    Time frame: Week 0, 12

    Interleukin-6 concentration in blood measured in pg/mL

Secondary outcomes

  1. Enjoyment

    Time frame: Up to 12 weeks

    PACES Score results will be between 18 to 126. A higher score indicates a higher enjoyment level.

Study contacts

Contact information is provided by the study sponsor or research team.

Nani C Sudarsono, Doctor

CONTACT

[email protected]

+62816736605

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparative Effects of High-Intensity Circuit Training and Moderate-Intensity Continuous Training on Various Health Parameters in Overweight Young Adults

Acronym: HiMod Impact

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Jun 6, 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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