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

NCT03361644 | Completed DMC

• 2 other identifiers: HM20010365R21HD090448
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity; Adolescent Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Body Mass Index (BMI)

  12 weeks

• Change in Blood Lipid Levels

  12 weeks

• Change in Body Composition

  12 weeks

• Participant Attendance

  12 weeks

• Achievement of Heart Rate Goals.

  12 weeks

Study Arms (2)

High-Intensity Interval Training

EXPERIMENTAL

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

Behavioral: High-Intensity Interval Training

Moderate-Intensity Continuous Training

ACTIVE COMPARATOR

Physical activity at a sustained moderate heart rate.

Behavioral: Moderate-Intensity Continuous Training

Interventions

High-Intensity Interval Training BEHAVIORAL

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.

High-Intensity Interval Training

Moderate-Intensity Continuous Training BEHAVIORAL

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.

Moderate-Intensity Continuous Training

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, 23239, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Weight Loss

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Edmond P Wickham, MD

  VCU Departments of Pediatrics and Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x3 repeated-measures randomized control trial.

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 5, 2017
• Study Start: February 8, 2018
• Primary Completion: January 13, 2020
• Study Completion: February 20, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)