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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity; Weight Loss; Adolescent Obesity
• Intervention / Treatment: Behavioral: High-Intensity Interval Training; Behavioral: Moderate-Intensity Continuous Training

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Henrico, Virginia, United States, 23239
      • Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory fitness	The two training methods will be compared for how they impact participants' fitness levels as assessed during a graded exercise tolerance test.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index (BMI)	The two training methods will be compared for changes in participants' BMI in kg/m2	12 weeks
Change in Blood Lipid Levels	The two training methods will be compared for changes in fasting lipid levels.	12 weeks
Change in Body Composition	The two training methods will be compared for differences in changes of percent body fat.	12 weeks
Participant Attendance	The two training methods will be compared for differences in rates of participant attendance at intervention sessions.	12 weeks
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.	12 weeks
Acceptability of exercise	The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.	12 weeks
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.	12 weeks
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.	16 weeks
Weight loss maintenance	The two training methods will be compared for changes in BMI 1 month after completion of the intervention.	16 weeks.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Edmond P Wickham, MD, VCU Departments of Pediatrics and Internal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): January 13, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Pediatric Obesity; Weight Loss
• Other Study ID Numbers: HM20010365; R21HD090448 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No