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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Body Composition as measured by DXA
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Coca-Cola Company

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.

General Publications

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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