An interventional study of High-Intensity Interval Training and Moderate-Intensity Continuous Training in Pediatric Obesity, Adolescent Obesity and Weight Loss, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Treatment
Among 12 studies in Pediatric Obesity by Virginia Commonwealth University — 1 open to participants now, 1 under way, none of them phase 3. Pediatric Obesity · Virginia Commonwealth University.
Among the 12 studies in Pediatric Obesity by Virginia Commonwealth University, this one is the 7th largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2018, is one of 11 with no phase, and was the 7th registered.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
Browse Pediatric Obesity studies →1 of the 12 studies in Pediatric Obesity by Virginia Commonwealth University is open now, in 1 country. Recruiting first, the newest first:
Virginia Commonwealth University · Sites in United States
By country, each count listing its studies:
Of the 124 Pediatric Obesity studies recruiting now, 19 (15%) set no upper age limit and 103 (83%) stop at 75 or younger; 114 take children under 18; 69 take healthy volunteers.
This study: 12 Years to 16 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2018.
This study's enrollment of 80 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Median enrollment 110 across the 11 interventional studies, 55 across the 1 observational. Of the 11 that completed or were terminated, 3 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Pediatric Obesity by Virginia Commonwealth University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brief periods of vigorous physical activity separated by short periods of rest.
Behavioral: High-Intensity Interval Training
Physical activity at a sustained moderate heart rate.
Behavioral: Moderate-Intensity Continuous 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.
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.
Cardiorespiratory fitness
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
Change in Body Mass Index (BMI)
The two training methods will be compared for changes in participants' BMI in kg/m2
Time frame: 12 weeks
Change in Blood Lipid Levels
The two training methods will be compared for changes in fasting lipid levels.
Time frame: 12 weeks
Change in Body Composition
The two training methods will be compared for differences in changes of percent body fat.
Time frame: 12 weeks
Participant Attendance
The two training methods will be compared for differences in rates of participant attendance at intervention sessions.
Time frame: 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.
Time frame: 12 weeks
Acceptability of exercise
The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks
Weight loss maintenance
The two training methods will be compared for changes in BMI 1 month after completion of the intervention.
Time frame: 16 weeks.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Jan 2020, 23 months.
Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 23 months is close to that.
Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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