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High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents (HIIT-MAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01935323
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : January 12, 2016
The Coca-Cola Company
Information provided by (Responsible Party):
David Allison, Phd, University of Alabama at Birmingham

Brief Summary:
6-week, single site, two parallel arm, randomized, controlled trial comparing the effectiveness of a High Intensity Interval Training (HIIT) versus a continuous Moderate Intensity Training (MIT) program on cardiovascular and metabolic health outcomes in overweight adolescent males. HIIT training may be a potent time-efficient strategy to induce similar metabolic and cardiovascular adaptations typically associated with MIT.

Condition or disease Intervention/treatment Phase
Metabolism Physical Fitness Other: High Intensity Interval Training Other: Moderate Intensity Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents.
Study Start Date : February 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: High Intensity Interval Training
Participants will perform the HIIT protocol on an electronically-braked cycle ergometer (Quinton Excalibur, Quinton Instrument Company, Bothell, WA). Participants will perform a 20-minute protocol, consisting of four minutes of cycling at 15% of maximum anaerobic power (Max-AP) followed by 30 seconds at 85% of Max-AP. These workloads will be based upon pre-trial Wingate tests. This cycle was repeated four times within each protocol, ending with two minutes at 15% of Max-AP. This will be performed 3d/wk for 6wks, with at least 24 hrs between each session.
Other: High Intensity Interval Training
Active Comparator: Moderate Intensity Training
Participants will perform 45-60 min (graduated over time to 60) of continuous cycling at 65% of VO¬2peak on a Monark cycle ergometer. Workload will be based upon pre-trial VO¬2peak testing. MIT exercise will be performed 5d/wk for 6wks.
Other: Moderate Intensity Training

Primary Outcome Measures :
  1. Body Composition as measured by DXA [ Time Frame: Baseline and 6 weeks ]

Secondary Outcome Measures :
  1. Body Weight [ Time Frame: Baseline and 6 weeks ]
  2. Blood Pressure [ Time Frame: Baseline and 6 weeks ]
  3. Body Mass Index [ Time Frame: Baseline and 6 weeks ]
  4. Peak uptake of volume of oxygen [ Time Frame: Baseline and 6 weeks ]
  5. Wingate Cycle test [ Time Frame: Baseline and 6 weeks ]
  6. LDL Cholesterol [ Time Frame: Baseline and 6 weeks ]
  7. HDL Cholesterol [ Time Frame: Baseline and 6 weeks ]
  8. Triglycerides [ Time Frame: Baseline and 6 weeks ]
  9. Glucose [ Time Frame: Baseline and 6 weeks ]
  10. Insulin [ Time Frame: Baseline and 6 weeks ]
  11. Ghrelin [ Time Frame: Baseline and 6 weeks ]
  12. Leptin [ Time Frame: Baseline and 6 weeks ]
  13. Adiponectin [ Time Frame: Baseline and 6 weeks ]
  14. PYY [ Time Frame: Baseline and 6 weeks ]
  15. IL-6 [ Time Frame: Baseline and 6 weeks ]
  16. TNF-alpha [ Time Frame: Baseline and 6 weeks ]
  17. Total antioxidant capacity [ Time Frame: Baseline and 6 weeks ]
  18. Protein Carbonyls [ Time Frame: Baseline and 6 weeks ]
    ELISA assay purchased from NW LifeSciences. Prior to analysis, all serum samples were assayed for protein concentration based on the methods of Bradford and adjusted to 4 mg・mL-1 protein using a phosphate buffer. Protein carbonyls, a measure of protein oxidation, were analyzed in duplicate in 50 μl of sera using a commercially available ELISA kit (NWK-PCK01).The intra- and interassay coefficients of variation were 2.7 % and 5%. The lower detection limit of the assay was 0.1 nmol/mg.

  19. Free living energy expenditure as measured by accelerometer [ Time Frame: Baseline and 6 weeks ]
  20. Appetite/satiety measures [ Time Frame: baseline & 6 weeks ]
    composite score

  21. Quality & satisfaction with life [ Time Frame: baseline & 6 weeks ]
    composite score

  22. Rate of perceived exertion during exercise via Borg Scale [ Time Frame: baseline and 6 weeks ]
  23. 24-hour dietary recall [ Time Frame: pre-baseline, baseline, 6 weeks ]
  24. Self Motivation Inventory [ Time Frame: baseline and 6 weeks ]
  25. Profile of Mood States [ Time Frame: baseline & 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   17 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ages 17-22
  • Men
  • BMI (25.0 - 35.0 kg/m2)
  • Interested in improving health and fitness

Exclusion Criteria:

  • Weight loss or gain of >10% of body weight in the past 6 months for any reason.
  • Currently taking medication that suppresses or stimulates appetite.
  • History of prior surgical procedure for weight control or liposuction.
  • Current smoker.

Any major disease, including:

  • Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
  • Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
  • Diagnosed heart conditions.
  • Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
  • Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
  • Asthma.
  • Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.

    • Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; unwilling to accept treatment assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.
    • Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
    • Any active use of illegal or illicit drugs.
    • Excessive alcohol intake defined as an average consumption of 3 or more alcohol containing beverages daily.
    • Unwilling to limit alcohol intake to ≤2 drink per day (one drink = 4 oz. wine, 12 oz. beer, or ½ shot of liquor).
    • Current exerciser (>30 min organized exercise per week).
    • Indication of unsuitability of current health for exercise protocol (PARQ).
    • Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01935323

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United States, Alabama
UAB Physiology Lab
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
The Coca-Cola Company
Additional Information:
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Responsible Party: David Allison, Phd, Principal Investigator, University of Alabama at Birmingham Identifier: NCT01935323    
Other Study ID Numbers: F121101004
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Keywords provided by David Allison, Phd, University of Alabama at Birmingham:
high intensity interval training
aerobic exercise
insulin sensitivity
cardiovascular fitness
Additional relevant MeSH terms:
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Body Weight