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

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ClinicalTrials.gov Identifier: NCT01935323
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : January 12, 2016
Sponsor:
Collaborator:
The Coca-Cola Company
Information provided by (Responsible Party):
David Allison, Phd, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE June 20, 2013
First Posted Date  ICMJE September 5, 2013
Last Update Posted Date January 12, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2013)
Body Composition as measured by DXA [ Time Frame: Baseline and 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2013)
  • Body Weight [ Time Frame: Baseline and 6 weeks ]
  • Blood Pressure [ Time Frame: Baseline and 6 weeks ]
  • Body Mass Index [ Time Frame: Baseline and 6 weeks ]
  • Peak uptake of volume of oxygen [ Time Frame: Baseline and 6 weeks ]
  • Wingate Cycle test [ Time Frame: Baseline and 6 weeks ]
  • LDL Cholesterol [ Time Frame: Baseline and 6 weeks ]
  • HDL Cholesterol [ Time Frame: Baseline and 6 weeks ]
  • Triglycerides [ Time Frame: Baseline and 6 weeks ]
  • Glucose [ Time Frame: Baseline and 6 weeks ]
  • Insulin [ Time Frame: Baseline and 6 weeks ]
  • Ghrelin [ Time Frame: Baseline and 6 weeks ]
  • Leptin [ Time Frame: Baseline and 6 weeks ]
  • Adiponectin [ Time Frame: Baseline and 6 weeks ]
  • PYY [ Time Frame: Baseline and 6 weeks ]
  • IL-6 [ Time Frame: Baseline and 6 weeks ]
  • TNF-alpha [ Time Frame: Baseline and 6 weeks ]
  • Total antioxidant capacity [ Time Frame: Baseline and 6 weeks ]
  • 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.
  • Free living energy expenditure as measured by accelerometer [ Time Frame: Baseline and 6 weeks ]
  • Appetite/satiety measures [ Time Frame: baseline & 6 weeks ]
    composite score
  • Quality & satisfaction with life [ Time Frame: baseline & 6 weeks ]
    composite score
  • Rate of perceived exertion during exercise via Borg Scale [ Time Frame: baseline and 6 weeks ]
  • 24-hour dietary recall [ Time Frame: pre-baseline, baseline, 6 weeks ]
  • Self Motivation Inventory [ Time Frame: baseline and 6 weeks ]
  • Profile of Mood States [ Time Frame: baseline & 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents
Official Title  ICMJE High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Metabolism
  • Physical Fitness
Intervention  ICMJE
  • Other: High Intensity Interval Training
  • Other: Moderate Intensity Training
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: Moderate Intensity Training
Publications * Fisher G, Brown AW, Bohan Brown MM, Alcorn A, Noles C, Winwood L, Resuehr H, George B, Jeansonne MM, Allison DB. High Intensity Interval- vs Moderate Intensity- Training for Improving Cardiometabolic Health in Overweight or Obese Males: A Randomized Controlled Trial. PLoS One. 2015 Oct 21;10(10):e0138853. doi: 10.1371/journal.pone.0138853. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2015)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2013)
36
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 17 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01935323
Other Study ID Numbers  ICMJE F121101004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Allison, Phd, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE The Coca-Cola Company
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP