The Effectiveness and Safety of HIIT in Overweight Male Subjects
Condition: Overweight; Overweight or Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Increased prevalence of overweight and obesity is one of the main health problems recently.
      Energy balance from nutrition intake and energy expenditure through physical activity,
      especially structured physical activity, is needed to prevent overweight individuals become
      obese individuals. This research objective is to explore the effectiveness and safety of
      structured high intensity interval training in male young adults subjects with overweight
      based on change of body composition, oxidative stress and inflammatory markers. This research
      used experimental model to test structured high intensity interval training program with
      pre-post test in single group. Comprehensive analysis of training effect in this research
      consists of measurement of several parameters, such as body composition, inflammatory
      markers, and oxidative stress markers as the benchmark of training safety. Browning white
      adipose tissue and cognitive function are complement parameters to the assessment of training
      effectiveness. Daily food record and physical activity for 3 x 24 hours will be carried out
      periodically to control confounding factors.
    

Detailed description: 
      -  Subjects are recruited via e-flyer distributed online across university departments.
           Individual who is interested in study participation fills out screening form. Research
           assistants screen subjects eligibility. Subjects are coded based on the order of
           screening form fulfillment.

        -  Research assistants are using the standard operational procedures for each assessments.
           Training for the research assistants precedes the data collection to ensure the
           similarity of understanding and skills during measurements. One research assistant
           responsible for scheduling the assessments and training sessions. Continuous evaluation
           are planned weekly to provide room for improvements in the process of data collection.

        -  Sample size assessment is measured from 5 primary output by a research assistants using
           sample size calculation website for single intervention clinical trial.

        -  Investigator use paper based data collection for each assessment and during training
           sessions. Subject are encouraged to report any symptoms and signs during intervention
           period in each meeting with the research assistants or via online messaging. Any reports
           will be documented in separated form. One research assistant makes sure the data fields
           are completed in each measurements and during training sessions. The assistant also
           check the similarity of the data entered in the master table.

        -  Data analysis will be lead by one research assistant using newest version of SPSS
           software. The analysis will be started after the baseline measurement is completed
           although the data collection is not finished. All numeric data will be presented as mean
           and standard deviations if normally distributed or median and minimum maximum range if
           not normally distributed. Paired t-test will be used to identify the difference before
           and after the intervention if the data are normally distributed. If the data are not
           normally distributed, Wilcoxon test will be used to identify the difference before and
           after the intervention.

      To ensure that there is no missing data, the research assistant who responsible for data
      completeness will perform daily checking. Any missing data will be stated and immediately
      completed. Research assistants will provide close supervision for each subject to ensure the
      delivery of all necessary reports.
    

Intervention name(s): HIIT
Intervention type(s): Other
Intervention description(s): 3x/week high intensity interval training for 12 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high intensity interval training; overweight; young male