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The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity

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ClinicalTrials.gov Identifier: NCT03361644
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The study will compare the effects of High Intensity Interval Training (HIIT) with Moderate Intensity Continuous Training (CMIT) as part of a lifestyle intervention program on BMI change in adolescents age 12-16 with obesity.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Adolescent Obesity Weight Loss Behavioral: High-Intensity Interval Training Behavioral: Moderate-Intensity Continuous Training Not Applicable

Detailed Description:

Adolescents will be randomized to a 12-week lifestyle intervention including behavioral and dietary interventions, and one of two exercise training conditions, HIIT or CMIT). Adolescents in the HIIT treatment will participate in treadmill exercise in 1-minute intervals of challenging intensities with recovery periods in between, gradually increasing the number of intervals over the course of the study. Adolescents in the CMIT treatment will participate in a constant moderate intensity treadmill exercise, gradually increasing the duration of the exercise over the course of the study.

Both parents and teens will have height and weight measurements taken, complete behavior questionnaires and wear an activity monitor for one week at baseline, 12 weeks and 16 weeks.

Adolescents will have a physical exam by a study medical provider before starting the intervention. Adolescents will also have blood work, an oral glucose tolerance test, an electrocardiogram, body composition measurements and a maximal graded exercise test done at baseline, and again at one or more time points. Adolescents will also complete a detailed food log at those time points.

Adolescents will exercise at the study gym 3 evenings a week for 12 weeks. On one of those evenings teens will also attend a 60-minute individual behavioral weight management session. Nine of these are with a behavior coach, and 3 with a dietitian. Parents will also attend one introductory session with the behavior coach, join the teen for the 3 sessions with the dietitian, and review adolescent individual goals and identify parent support goals at the end of each behavior session.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2x3 repeated-measures randomized control trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: High-Intensity Interval Training
Brief periods of vigorous physical activity separated by short periods of rest.
Behavioral: High-Intensity Interval Training
Participants assigned to HIIT will participate in treadmill exercise in intervals consisting of 1 minute intervals of challenging intensities with recovery periods in between, gradually increasing the number of intervals over the course of the study.

Active Comparator: Moderate-Intensity Continuous Training
Physical activity at a sustained moderate heart rate.
Behavioral: Moderate-Intensity Continuous Training
Participants assigned to CMIT will participate in constant moderate intensity treadmill exercise, gradually increasing the duration of the exercise over the course of the study.




Primary Outcome Measures :
  1. Cardiorespiratory fitness [ Time Frame: 12 weeks ]
    The two training methods will be compared for how they impact participants' fitness levels as assessed during a graded exercise tolerance test.


Secondary Outcome Measures :
  1. Change in Body Mass Index (BMI) [ Time Frame: 12 weeks ]
    The two training methods will be compared for changes in participants' BMI in kg/m2

  2. Change in Blood Lipid Levels [ Time Frame: 12 weeks ]
    The two training methods will be compared for changes in fasting lipid levels.

  3. Change in Body Composition [ Time Frame: 12 weeks ]
    The two training methods will be compared for differences in changes of percent body fat.

  4. Participant Attendance [ Time Frame: 12 weeks ]
    The two training methods will be compared for differences in rates of participant attendance at intervention sessions.

  5. Achievement of Heart Rate Goals. [ Time Frame: 12 weeks ]
    The two training methods will be compared for differences in rates of achievement of heart rate goals during exercise training sessions.

  6. Acceptability of exercise [ Time Frame: 12 weeks ]
    The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.

  7. Feasibility of Exercise [ Time Frame: 12 weeks ]
    The two training methods will be compared for differences in participants' confidence in being able ability to continue to participate in the assigned type of exercise.

  8. Maintenance of lifestyle changes [ Time Frame: 16 weeks ]
    The two training methods will be compared for participants' frequency of participation in physical activity 1 month after completion of the intervention.

  9. Weight loss maintenance [ Time Frame: 16 weeks. ]
    The two training methods will be compared for changes in BMI 1 month after completion of the intervention.



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age of 12 to 16 years with obesity (BMI ≥95% percentile for age and gender according to the CDC Growth Charts).
  • Have a parent (or legal guardian) who is willing to provide basic demographic information, complete required surveys, and attend portions of the weekly adolescent-focused behavioral weight management sessions.
  • Participating parent must reside with the adolescent within a 30-mile distance of the study site.

Exclusion Criteria:

  • Non-English speaking;
  • Weight >300 lbs;
  • Medical condition(s) that may be associated with unintentional weight change (e.g., hypothalamic injury, Prader-Willi, untreated thyroid disease or malignancy);
  • Diabetes mellitus diagnosed by history or a fasting glucose ≥126 mg/dl (subjects with glucose intolerance or "prediabetes" will eligible for study participation);
  • Use of insulin sensitizing agents (e.g. metformin), antihypertensive medications, medications for treatment of hyperlipidemia, oral contraceptives, oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation;
  • Medical condition(s) that may be negatively impacted by high-intensity exercise training;
  • Psychiatric, cognitive, developmental or physical conditions that would impair the adolescent's ability to complete assessments, participate in behavioral weight management sessions, or conduct physical activity;
  • Reports of compensatory behaviors (i.e., vomiting, laxative abuse, excessive exercise) in the past 3 months;
  • Current pregnancy or plan to become pregnant during study period;
  • Previous participation in the TEENS study at Virginia Commonwealth University;
  • Current participation in another weight loss program; or
  • Personal history of weight loss surgery;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361644


Contacts
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Contact: Janet D Delorme, M.S. (804) 527-4756 janet.delorme@vcuhealth.org
Contact: Sarah E Farthing, M.S. (804) 527-4759 sarah.malone@vcuhealth.org

Locations
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United States, Virginia
Children's Hospital of Richmond at VCU Healthy Lifestyles Center Recruiting
Henrico, Virginia, United States, 23239
Contact: Janet D Delorme, MS    804-527-4756    jdelorm@vcu.edu   
Contact: Melanie K Bean, Ph.D.    (804) 527-4765    mkbean@vcu.edu   
Principal Investigator: Edmond P Wickham, MD, MPH         
Sub-Investigator: Melanie K Bean, Ph.D.         
Sub-Investigator: Ronald K Evans, Ph.D.         
Sub-Investigator: Le Kang, Ph.D.         
Sub-Investigator: Trang Le, MD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Edmond P Wickham, MD VCU Departments of Pediatrics and Internal Medicine

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03361644     History of Changes
Other Study ID Numbers: HM20010365
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes