Clinical trial NCT01935323: High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents
Official title: High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism
Physical Fitness
Keywords: high intensity interval training
aerobic exercise
insulin sensitivity
obesity
cardiovascular fitness
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: The Coca-Cola Company
First posted: 2013-09-05
Enrollment: 30
Sex: MALE
Minimum age (years): 17
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Body Composition as measured by DXA
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Body Weight
timeFrame: Baseline and 6 weeks
measure: Blood Pressure
timeFrame: Baseline and 6 weeks
measure: Body Mass Index
timeFrame: Baseline and 6 weeks
measure: Peak uptake of volume of oxygen
timeFrame: Baseline and 6 weeks
measure: Wingate Cycle test
timeFrame: Baseline and 6 weeks
measure: LDL Cholesterol
timeFrame: Baseline and 6 weeks
measure: HDL Cholesterol
timeFrame: Baseline and 6 weeks
measure: Triglycerides
timeFrame: Baseline and 6 weeks
measure: Glucose
timeFrame: Baseline and 6 weeks
measure: Insulin
timeFrame: Baseline and 6 weeks
measure: Ghrelin
timeFrame: Baseline and 6 weeks
measure: Leptin
timeFrame: Baseline and 6 weeks
measure: Adiponectin
timeFrame: Baseline and 6 weeks
measure: PYY
timeFrame: Baseline and 6 weeks
measure: IL-6
timeFrame: Baseline and 6 weeks
measure: TNF-alpha
timeFrame: Baseline and 6 weeks
measure: Total antioxidant capacity
timeFrame: Baseline and 6 weeks
measure: Protein Carbonyls
timeFrame: Baseline and 6 weeks
measure: Free living energy expenditure as measured by accelerometer
timeFrame: Baseline and 6 weeks
measure: Appetite/satiety measures
timeFrame: baseline & 6 weeks
measure: Quality & satisfaction with life
timeFrame: baseline & 6 weeks
measure: Rate of perceived exertion during exercise via Borg Scale
timeFrame: baseline and 6 weeks
measure: 24-hour dietary recall
timeFrame: pre-baseline, baseline, 6 weeks
measure: Self Motivation Inventory
timeFrame: baseline and 6 weeks
measure: Profile of Mood States
timeFrame: baseline & 6 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Physiology Lab
state: Alabama
Study officials:
References:
citation: 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.