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

Primary Purpose

Pediatric Obesity, Adolescent Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Intensity Interval Training
Moderate-Intensity Continuous Training
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-Intensity Interval Training

Moderate-Intensity Continuous Training

Arm Description

Brief periods of vigorous physical activity separated by short periods of rest.

Physical activity at a sustained moderate heart rate.

Outcomes

Primary Outcome Measures

Cardiorespiratory fitness
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

Change in Body Mass Index (BMI)
The two training methods will be compared for changes in participants' BMI in kg/m2
Change in Blood Lipid Levels
The two training methods will be compared for changes in fasting lipid levels.
Change in Body Composition
The two training methods will be compared for differences in changes of percent body fat.
Participant Attendance
The two training methods will be compared for differences in rates of participant attendance at intervention sessions.
Achievement of Heart Rate Goals.
The two training methods will be compared for differences in rates of achievement of heart rate goals during exercise training sessions.
Acceptability of exercise
The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.
Feasibility of Exercise
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.
Maintenance of lifestyle changes
The two training methods will be compared for participants' frequency of participation in physical activity 1 month after completion of the intervention.
Weight loss maintenance
The two training methods will be compared for changes in BMI 1 month after completion of the intervention.

Full Information

First Posted
November 17, 2017
Last Updated
April 5, 2021
Sponsor
Virginia Commonwealth University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03361644
Brief Title
The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity
Official Title
The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
January 13, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Adolescent Obesity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2x3 repeated-measures randomized control trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-Intensity Interval Training
Arm Type
Experimental
Arm Description
Brief periods of vigorous physical activity separated by short periods of rest.
Arm Title
Moderate-Intensity Continuous Training
Arm Type
Active Comparator
Arm Description
Physical activity at a sustained moderate heart rate.
Intervention Type
Behavioral
Intervention Name(s)
High-Intensity Interval Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moderate-Intensity Continuous Training
Intervention Description
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 Measure Information:
Title
Cardiorespiratory fitness
Description
The two training methods will be compared for how they impact participants' fitness levels as assessed during a graded exercise tolerance test.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Description
The two training methods will be compared for changes in participants' BMI in kg/m2
Time Frame
12 weeks
Title
Change in Blood Lipid Levels
Description
The two training methods will be compared for changes in fasting lipid levels.
Time Frame
12 weeks
Title
Change in Body Composition
Description
The two training methods will be compared for differences in changes of percent body fat.
Time Frame
12 weeks
Title
Participant Attendance
Description
The two training methods will be compared for differences in rates of participant attendance at intervention sessions.
Time Frame
12 weeks
Title
Achievement of Heart Rate Goals.
Description
The two training methods will be compared for differences in rates of achievement of heart rate goals during exercise training sessions.
Time Frame
12 weeks
Title
Acceptability of exercise
Description
The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.
Time Frame
12 weeks
Title
Feasibility of Exercise
Description
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.
Time Frame
12 weeks
Title
Maintenance of lifestyle changes
Description
The two training methods will be compared for participants' frequency of participation in physical activity 1 month after completion of the intervention.
Time Frame
16 weeks
Title
Weight loss maintenance
Description
The two training methods will be compared for changes in BMI 1 month after completion of the intervention.
Time Frame
16 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmond P Wickham, MD
Organizational Affiliation
VCU Departments of Pediatrics and Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Richmond at VCU Healthy Lifestyles Center
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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