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Completed

NCT Number: NCT01935323

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.

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Key information

Age range

17 year–22 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UAB Physiology Lab

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval Training

Other

Moderate Intensity Training

Other

Primary outcomes

  1. Body Composition as measured by DXA

    Time frame: Baseline and 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • The Coca-Cola Company

Registry information

Official study title

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

Acronym: HIIT-MAX

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 5, 2013
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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