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

January 8, 2016 updated by: David Allison, Phd, University of Alabama at Birmingham

High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents.

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Physiology Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 22 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Composition as measured by DXA
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Blood Pressure
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Body Mass Index
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Peak uptake of volume of oxygen
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Wingate Cycle test
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
LDL Cholesterol
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
HDL Cholesterol
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Triglycerides
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Glucose
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Insulin
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Ghrelin
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Leptin
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Adiponectin
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
PYY
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
IL-6
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
TNF-alpha
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Total antioxidant capacity
Time Frame: Baseline and 6 weeks
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.
Baseline and 6 weeks
Free living energy expenditure as measured by accelerometer
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Appetite/satiety measures
Time Frame: baseline & 6 weeks
composite score
baseline & 6 weeks
Quality & satisfaction with life
Time Frame: baseline & 6 weeks
composite score
baseline & 6 weeks
Rate of perceived exertion during exercise via Borg Scale
Time Frame: baseline and 6 weeks
baseline and 6 weeks
24-hour dietary recall
Time Frame: pre-baseline, baseline, 6 weeks
pre-baseline, baseline, 6 weeks
Self Motivation Inventory
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Profile of Mood States
Time Frame: baseline & 6 weeks
baseline & 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (ESTIMATE)

September 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F121101004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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