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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Alabama at Birmingham
Sponsor:
Collaborator:
The Coca-Cola Company
Information provided by (Responsible Party):
David Allison, Phd, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01935323
First received: June 20, 2013
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention
Metabolism
Physical Fitness
Other: High Intensity Interval Training
Other: Moderate Intensity Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents.

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Body Composition as measured by DXA [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body Weight [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Peak uptake of volume of oxygen [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Wingate Cycle test [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • LDL Cholesterol [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • HDL Cholesterol [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Ghrelin [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Leptin [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Adiponectin [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • PYY [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • IL-6 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • TNF-alpha [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Total antioxidant capacity [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Protein Carbonyls [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Appetite/satiety measures [ Time Frame: baseline & 6 weeks ] [ Designated as safety issue: No ]
    composite score

  • Quality & satisfaction with life [ Time Frame: baseline & 6 weeks ] [ Designated as safety issue: No ]
    composite score

  • Rate of perceived exertion during exercise via Borg Scale [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • 24-hour dietary recall [ Time Frame: pre-baseline, baseline, 6 weeks ] [ Designated as safety issue: No ]
  • Self Motivation Inventory [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Profile of Mood States [ Time Frame: baseline & 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   17 Years to 22 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935323

Contacts
Contact: Amy S Thomas, MPH, RD 205-975-9273 amysusan@uab.edu

Locations
United States, Alabama
UAB Physiology Lab Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: David B Allison, PhD         
Sub-Investigator: Gordon Fisher, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
The Coca-Cola Company
  More Information

Additional Information:
No publications provided

Responsible Party: David Allison, Phd, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01935323     History of Changes
Other Study ID Numbers: F121101004
Study First Received: June 20, 2013
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
high intensity interval training
aerobic exercise
insulin sensitivity
obesity
cardiovascular fitness

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014