Pediatric ObesityNCT03361644
The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity
A study testing High-Intensity Interval Training and Moderate-Intensity Continuous Training in people with Pediatric Obesity and Adolescent Obesity, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Adolescent Obesity, Weight Loss
- What is being tested?
- High-Intensity Interval Training and Moderate-Intensity Continuous Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Richmond at VCU Healthy Lifestyles Center
Henrico, Virginia, 23239
About this study
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.
Read the 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.
- Conditions
- Pediatric Obesity, Adolescent Obesity, Weight Loss
- Being tested
- High-Intensity Interval Training, Moderate-Intensity Continuous Training
- Medical subject headings
- Pediatric Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training | Experimental | Brief periods of vigorous physical activity separated by short periods of rest. Receives: Behavioral: High-Intensity Interval Training |
| Moderate-Intensity Continuous Training | Active comparator | Physical activity at a sustained moderate heart rate. Receives: Behavioral: Moderate-Intensity Continuous Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
The two training methods will be compared for how they impact participants' fitness levels as assessed during a graded exercise tolerance test.
Measured: 12 weeks
Secondary outcomes (9)
Change in Body Mass Index (BMI)
The two training methods will be compared for changes in participants' BMI in kg/m2
Measured: 12 weeks
Change in Blood Lipid Levels
The two training methods will be compared for changes in fasting lipid levels.
Measured: 12 weeks
Change in Body Composition
The two training methods will be compared for differences in changes of percent body fat.
Measured: 12 weeks
Participant Attendance
The two training methods will be compared for differences in rates of participant attendance at intervention sessions.
Measured: 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.
Measured: 12 weeks
Acceptability of exercise
The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Weight loss maintenance
The two training methods will be compared for changes in BMI 1 month after completion of the intervention.
Measured: 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start8 Feb 2018
- Primary completion13 Jan 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2x3 repeated-measures randomized control trial.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Edmond P Wickham, MD, Principal investigator, VCU Departments of Pediatrics and Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361644
- Sponsor's protocol ID
- HM20010365
- Other IDs
- R21HD090448
- Status last verified
- Apr 2021
- First submitted
- 17 Nov 2017
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity
- ClinicalTrials.gov ID
- NCT03361644
- Acronym / sponsor ID
- HM20010365
- Conditions
- Pediatric Obesity, Adolescent Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2x3 repeated-measures randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training | Experimental | Behavioral: High-Intensity Interval TrainingBrief periods of vigorous physical activity separated by short periods of rest. |
| Moderate-Intensity Continuous Training | Active comparator | Behavioral: Moderate-Intensity Continuous TrainingPhysical activity at a sustained moderate heart rate. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval TrainingParticipants 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. | Behavioural | High-Intensity Interval Training |
| Moderate-Intensity Continuous TrainingParticipants assigned to CMIT will participate in constant moderate intensity treadmill exercise, gradually increasing the duration of the exercise over the course of the study. | Behavioural | Moderate-Intensity Continuous Training |
Primary outcome
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.
9 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: 12 weeks
Change in Blood Lipid Levels
Time frame: 12 weeks
Change in Body Composition
Time frame: 12 weeks
Participant Attendance
Time frame: 12 weeks
Achievement of Heart Rate Goals.
Time frame: 12 weeks
Acceptability of exercise
Time frame: 12 weeks
Feasibility of Exercise
Time frame: 12 weeks
Maintenance of lifestyle changes
Time frame: 16 weeks
Weight loss maintenance
Time frame: 16 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmond P Wickham, MD principal investigator
VCU Departments of Pediatrics and Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training and Moderate-Intensity Continuous Training in people with Pediatric Obesity and Adolescent Obesity, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.