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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361644
• Other study ID #: HM20010365
• Secondary ID: R21HD090448
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: February 20, 2020

Study information

• Verified date: April 2021
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 20, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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;

Related Conditions & MeSH terms

• Adolescent Obesity
• Obesity
• Pediatric Obesity
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Richmond at VCU Healthy Lifestyles Center	Henrico	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

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