Childhood ObesityCASHNCT01821313
CASH- Children Active to Stay Healthy
A study testing Moderate exercise and High Intensity Interval Exercise in people with Childhood Obesity and Inflammation, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of high intensity interval exercise (HIIE) on inflammation and endothelial dysfunction found in children with obesity. Our working hypothesis is that, compared with obese children prescribed moderate exercise, obese children prescribed HIIE will demonstrate greater… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Inflammation
- What is being tested?
- Moderate exercise and High Intensity Interval Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Apr 2013
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 13-17 years old
- obesity (defined as as BMI≥ 95th percentile for age and sex as defined by the Centers for Disease Control
Who cannot join
- active participation in ≥30 minutes of vigorous exercise more than 2 days per week
- participation in an organized combined diet/exercise weight loss intervention
- acute inflammatory disease or febrile illness
- recent trauma or injury
- asthma requiring steroid use or that has resulted in hospitalization within 3 months prior to enrollment
- chronic disease known to affect inflammation (e.g. lupus)
- any renal, heart, or liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Intensity Interval Exercise on Inflammation and Endothelial Function in Children & Adolescents With Obesity
The purpose of this study is to examine the effects of high intensity interval exercise (HIIE) on inflammation and endothelial dysfunction found in children with obesity. Our working hypothesis is that, compared with obese children prescribed moderate exercise, obese children prescribed HIIE will demonstrate greater improvements in endothelial function and inflammatory markers following a 6-week exercise intervention.
Read the detailed description
Obesity, even in children, is generally accompanied by a state of chronic inflammation. To combat childhood obesity, clinicians and scientists recommend lifestyle interventions that include increased physical activity and exercise in an attempt to promote weight loss and, consequently, decrease comorbidities associated with excess adiposity. More importantly, it appears that the influence of regular exercise may offer children with obesity a multitude of health benefits, independent of weight loss. However, the intensity of exercise required to elicit significant health benefits is still unclear. Therefore, the aim of the present project is to study the influence of high intensity interval exercise (HIIE) on the existing inflammatory state found in obesity. Specifically, the proposed project will examine endothelial function and markers of inflammation, such as TNFa, IL-6, hsCRP, and adiponectin, in children with obesity before and after an exercise intervention. The data will then be used to determine if changes in these values differ in magnitude based on the intensity of exercise. Children with obesity will be randomized into either moderate exercise or HIIE groups, and attend sessions 3 times per week for 6 weeks. The moderate group will cycle continuously for 30 minutes at 65%-70% of maximal heart rate and the HIIE group will perform ten, 2-minute bouts at 90%-95% of maximal heart rate. Outcome measures of body composition, aerobic capacity, blood lipids, glucose metabolism, endothelial function, and inflammation will be measured pre- and post-intervention. Results may help in establishing exercise protocols not only for children with obesity, but also other inflammatory diseases such as diabetes, cancer, and arthritis.
- Conditions
- Childhood Obesity, Inflammation
- Being tested
- Moderate exercise, High Intensity Interval Exercise
- Keywords
- Childhood obesity, Inflammation, Endothelial function, Exercise
- Medical subject headings
- Pediatric Obesity, Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate exerciseOther
High Intensity Interval ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Moderate exercise | Experimental | The subject will participate in a 6-week exercise intervention, 3 days per week on a cycle ergometer. The moderate exercise group will begin with a five-minute warm-up, cycling at 50-55% of the subject's maximal heart rate as determined by the initial fitness assessment. Following the warm-up, the moderate group will cycle for 30 minutes at 65-70% of maximal heart rate. The subject will then complete a 5-minute cool-down at 50-55% of maximal heart rate. Heart rate will be measured via individual heart rate monitors. Receives: Other: Moderate exercise |
| High Intensity Interval Exercise (HIIE) | Active comparator | The subject will participate in a 6-week exercise intervention, 3 days per week on a cycle ergometer. The subjects in the HIIE group will begin with a five-minute warm-up at 50-55% of the subject's maximal heart rate as determined by the initial fitness assessment. Following the warm-up, the HIIE group will perform 10, two-minute exercise bouts at 90-95% of maximal heart rate, with one minute of active recovery at 55% of maximal heart rate between each interval for a total of 30 minutes. They will complete the test with a 5-minute cool-down at 50-55% of maximal heart rate. Heart rate will be measured via individual heart rate monitors. Receives: Other: High Intensity Interval Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation and endothelial function measured via forearm vascular resistance (FVR) and blood markers including tumor necrosis factor alpha (TNF-a), interleukin-6 (IL-6), adiponectin, high sensitivity C-reactive protein (hsCRP), and endothelin 1.
The primary outcomes are the percent change in FVR and in inflammatory markers (hsCRP, IL-6, TNF-α, and adiponectin) from pre- to post-intervention in both groups.
Measured: Within one month pre and one month post-intervention
Secondary outcomes (1)
Percent difference in inflammation and endothelial function between moderate and high intensity interval exercise (HIIE) groups.
Measured: Within one month pre- and no more than one month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ihuoma Eneli, Nationwide Children's Hospital
- Investigators
- Ihuoma Eneli, MD, Principal investigator, Nationwide Children's HospitalAndrea Bonny, MD, Principal investigator, Nationwide Children's HospitalRobert Hoffman, MD, Principal investigator, Nationwide Children's HospitalSteven T Devor, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821313
- Sponsor's protocol ID
- IRB12-00197
- Acronym
- CASH
- Status last verified
- Apr 2015
- First submitted
- 27 Mar 2013
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tjonna AE, Stolen TO, Bye A, Volden M, Slordahl SA, Odegard R, Skogvoll E, Wisloff U. Aerobic interval training reduces cardiovascular risk factors more than a multitreatment approach in overweight adolescents. Clin Sci (Lond). 2009 Feb;116(4):317-26. doi: 10.1042/CS20080249.
PubMed 18673303Tyldum GA, Schjerve IE, Tjonna AE, Kirkeby-Garstad I, Stolen TO, Richardson RS, Wisloff U. Endothelial dysfunction induced by post-prandial lipemia: complete protection afforded by high-intensity aerobic interval exercise. J Am Coll Cardiol. 2009 Jan 13;53(2):200-6. doi: 10.1016/j.jacc.2008.09.033.
PubMed 19130989Haram PM, Kemi OJ, Lee SJ, Bendheim MO, Al-Share QY, Waldum HL, Gilligan LJ, Koch LG, Britton SL, Najjar SM, Wisloff U. Aerobic interval training vs. continuous moderate exercise in the metabolic syndrome of rats artificially selected for low aerobic capacity. Cardiovasc Res. 2009 Mar 1;81(4):723-32. doi: 10.1093/cvr/cvn332. Epub 2008 Dec 1.
PubMed 19047339Ciolac EG, Bocchi EA, Bortolotto LA, Carvalho VO, Greve JM, Guimaraes GV. Effects of high-intensity aerobic interval training vs. moderate exercise on hemodynamic, metabolic and neuro-humoral abnormalities of young normotensive women at high familial risk for hypertension. Hypertens Res. 2010 Aug;33(8):836-43. doi: 10.1038/hr.2010.72. Epub 2010 May 7.
PubMed 20448634Tjonna AE, Lee SJ, Rognmo O, Stolen TO, Bye A, Haram PM, Loennechen JP, Al-Share QY, Skogvoll E, Slordahl SA, Kemi OJ, Najjar SM, Wisloff U. Aerobic interval training versus continuous moderate exercise as a treatment for the metabolic syndrome: a pilot study. Circulation. 2008 Jul 22;118(4):346-54. doi: 10.1161/CIRCULATIONAHA.108.772822. Epub 2008 Jul 7.
PubMed 18606913Moghadasi M, Mohebbi H, Rahmani-Nia F, Hassan-Nia S, Noroozi H, Pirooznia N. High-intensity endurance training improves adiponectin mRNA and plasma concentrations. Eur J Appl Physiol. 2012 Apr;112(4):1207-14. doi: 10.1007/s00421-011-2073-2. Epub 2011 Jul 17.
PubMed 21769734Giordano P, Del Vecchio GC, Cecinati V, Delvecchio M, Altomare M, De Palma F, De Mattia D, Cavallo L, Faienza MF. Metabolic, inflammatory, endothelial and haemostatic markers in a group of Italian obese children and adolescents. Eur J Pediatr. 2011 Jul;170(7):845-50. doi: 10.1007/s00431-010-1356-7. Epub 2011 Jan 6.
PubMed 21210148Hopkins ND, Stratton G, Tinken TM, McWhannell N, Ridgers ND, Graves LE, George K, Cable NT, Green DJ. Relationships between measures of fitness, physical activity, body composition and vascular function in children. Atherosclerosis. 2009 May;204(1):244-9. doi: 10.1016/j.atherosclerosis.2008.09.004. Epub 2008 Sep 9.
PubMed 18930229Kelly AS, Wetzsteon RJ, Kaiser DR, Steinberger J, Bank AJ, Dengel DR. Inflammation, insulin, and endothelial function in overweight children and adolescents: the role of exercise. J Pediatr. 2004 Dec;145(6):731-6. doi: 10.1016/j.jpeds.2004.08.004.
PubMed 15580192McMurray RG, Zaldivar F, Galassetti P, Larson J, Eliakim A, Nemet D, Cooper DM. Cellular immunity and inflammatory mediator responses to intense exercise in overweight children and adolescents. J Investig Med. 2007 Apr;55(3):120-9. doi: 10.2310/6650.2007.06031.
PubMed 17481381Meyer AA, Kundt G, Lenschow U, Schuff-Werner P, Kienast W. Improvement of early vascular changes and cardiovascular risk factors in obese children after a six-month exercise program. J Am Coll Cardiol. 2006 Nov 7;48(9):1865-70. doi: 10.1016/j.jacc.2006.07.035. Epub 2006 Oct 17.
PubMed 17084264Norris AL, Steinberger J, Steffen LM, Metzig AM, Schwarzenberg SJ, Kelly AS. Circulating oxidized LDL and inflammation in extreme pediatric obesity. Obesity (Silver Spring). 2011 Jul;19(7):1415-9. doi: 10.1038/oby.2011.21. Epub 2011 Feb 17.
PubMed 21331062Pedrosa C, Oliveira BM, Albuquerque I, Simoes-Pereira C, Vaz-de-Almeida MD, Correia F. Metabolic syndrome, adipokines and ghrelin in overweight and obese schoolchildren: results of a 1-year lifestyle intervention programme. Eur J Pediatr. 2011 Apr;170(4):483-92. doi: 10.1007/s00431-010-1316-2. Epub 2010 Oct 19.
PubMed 20957391Reinehr T, Kiess W, de Sousa G, Stoffel-Wagner B, Wunsch R. Intima media thickness in childhood obesity: relations to inflammatory marker, glucose metabolism, and blood pressure. Metabolism. 2006 Jan;55(1):113-8. doi: 10.1016/j.metabol.2005.07.016.
PubMed 16324929
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Interval Exercise on Inflammation and Endothelial Function in Children & Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT01821313
- Acronym / sponsor ID
- CASH / IRB12-00197
- Conditions
- Childhood Obesity, Inflammation
- Keywords
- Childhood obesity, Inflammation, Endothelial function, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 Apr 2013 (estimated)
- 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 purpose of this study is to examine the effects of high intensity interval exercise (HIIE) on inflammation and endothelial dysfunction found in children with obesity. Our working hypothesis is that, compared with obese children prescribed moderate exercise, obese children prescribed HIIE will demonstrate greater improvements in endothelial function and inflammatory markers following a 6-week exercise intervention.
Detailed description
Obesity, even in children, is generally accompanied by a state of chronic inflammation. To combat childhood obesity, clinicians and scientists recommend lifestyle interventions that include increased physical activity and exercise in an attempt to promote weight loss and, consequently, decrease comorbidities associated with excess adiposity. More importantly, it appears that the influence of regular exercise may offer children with obesity a multitude of health benefits, independent of weight loss. However, the intensity of exercise required to elicit significant health benefits is still unclear. Therefore, the aim of the present project is to study the influence of high intensity interval exercise (HIIE) on the existing inflammatory state found in obesity. Specifically, the proposed project will examine endothelial function and markers of inflammation, such as TNFa, IL-6, hsCRP, and adiponectin, in children with obesity before and after an exercise intervention. The data will then be used to determine if changes in these values differ in magnitude based on the intensity of exercise. Children with obesity will be randomized into either moderate exercise or HIIE groups, and attend sessions 3 times per week for 6 weeks. The moderate group will cycle continuously for 30 minutes at 65%-70% of maximal heart rate and the HIIE group will perform ten, 2-minute bouts at 90%-95% of maximal heart rate. Outcome measures of body composition, aerobic capacity, blood lipids, glucose metabolism, endothelial function, and inflammation will be measured pre- and post-intervention. Results may help in establishing exercise protocols not only for children with obesity, but also other inflammatory diseases such as diabetes, cancer, and arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate exercise | Experimental | Other: Moderate exerciseThe subject will participate in a 6-week exercise intervention, 3 days per week on a cycle ergometer. The moderate exercise group will begin with a five-minute warm-up, cycling at 50-55% of the subject's maximal heart rate as determined by the initial fitness assessment. Following the warm-up, the moderate group will cycle for 30 minutes at 65-70% of maximal heart rate. The subject will then complete a 5-minute cool-down at 50-55% of maximal heart rate. Heart rate will be measured via individual heart rate monitors. |
| High Intensity Interval Exercise (HIIE) | Active comparator | Other: High Intensity Interval ExerciseThe subject will participate in a 6-week exercise intervention, 3 days per week on a cycle ergometer. The subjects in the HIIE group will begin with a five-minute warm-up at 50-55% of the subject's maximal heart rate as determined by the initial fitness assessment. Following the warm-up, the HIIE group will perform 10, two-minute exercise bouts at 90-95% of maximal heart rate, with one minute of active recovery at 55% of maximal heart rate between each interval for a total of 30 minutes. They will complete the test with a 5-minute cool-down at 50-55% of maximal heart rate. Heart rate will be measured via individual heart rate monitors. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 13-17 years old
- obesity (defined as as BMI≥ 95th percentile for age and sex as defined by the Centers for Disease Control
Key exclusion criteria (7 listed)
- active participation in ≥30 minutes of vigorous exercise more than 2 days per week
- participation in an organized combined diet/exercise weight loss intervention
- acute inflammatory disease or febrile illness
- recent trauma or injury
- asthma requiring steroid use or that has resulted in hospitalization within 3 months prior to enrollment
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 |
|---|---|---|
| Moderate exercise | Other | Moderate exercise |
| High Intensity Interval Exercise | Other | High Intensity Interval Exercise (HIIE) |
Primary outcome
Inflammation and endothelial function measured via forearm vascular resistance (FVR) and blood markers including tumor necrosis factor alpha (TNF-a), interleukin-6 (IL-6), adiponectin, high sensitivity C-reactive protein (hsCRP), and endothelin 1.
Time frame: Within one month pre and one month post-intervention
The primary outcomes are the percent change in FVR and in inflammatory markers (hsCRP, IL-6, TNF-α, and adiponectin) from pre- to post-intervention in both groups.
1 secondary outcome
Percent difference in inflammation and endothelial function between moderate and high intensity interval exercise (HIIE) groups.
Time frame: Within one month pre- and no more than one month post-intervention
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 24 Apr 2015.
- Results publication: PubMed 18673303Tjonna AE, Stolen TO, Bye A, Volden M, Slordahl SA, Odegard R, Skogvoll E, Wisloff U. Aerobic interval training reduces cardiovascular risk factors more than a multitreatment approach in overweight adolescents. Clin Sci (Lond). 2009 Feb;116(4):317-26. doi: 10.1042/CS20080249.
- Results publication: PubMed 19130989Tyldum GA, Schjerve IE, Tjonna AE, Kirkeby-Garstad I, Stolen TO, Richardson RS, Wisloff U. Endothelial dysfunction induced by post-prandial lipemia: complete protection afforded by high-intensity aerobic interval exercise. J Am Coll Cardiol. 2009 Jan 13;53(2):200-6. doi: 10.1016/j.jacc.2008.09.033.
- Results publication: PubMed 19047339Haram PM, Kemi OJ, Lee SJ, Bendheim MO, Al-Share QY, Waldum HL, Gilligan LJ, Koch LG, Britton SL, Najjar SM, Wisloff U. Aerobic interval training vs. continuous moderate exercise in the metabolic syndrome of rats artificially selected for low aerobic capacity. Cardiovasc Res. 2009 Mar 1;81(4):723-32. doi: 10.1093/cvr/cvn332. Epub 2008 Dec 1.
- Results publication: PubMed 20448634Ciolac EG, Bocchi EA, Bortolotto LA, Carvalho VO, Greve JM, Guimaraes GV. Effects of high-intensity aerobic interval training vs. moderate exercise on hemodynamic, metabolic and neuro-humoral abnormalities of young normotensive women at high familial risk for hypertension. Hypertens Res. 2010 Aug;33(8):836-43. doi: 10.1038/hr.2010.72. Epub 2010 May 7.
- Results publication: PubMed 18606913Tjonna AE, Lee SJ, Rognmo O, Stolen TO, Bye A, Haram PM, Loennechen JP, Al-Share QY, Skogvoll E, Slordahl SA, Kemi OJ, Najjar SM, Wisloff U. Aerobic interval training versus continuous moderate exercise as a treatment for the metabolic syndrome: a pilot study. Circulation. 2008 Jul 22;118(4):346-54. doi: 10.1161/CIRCULATIONAHA.108.772822. Epub 2008 Jul 7.
- Results publication: PubMed 21769734Moghadasi M, Mohebbi H, Rahmani-Nia F, Hassan-Nia S, Noroozi H, Pirooznia N. High-intensity endurance training improves adiponectin mRNA and plasma concentrations. Eur J Appl Physiol. 2012 Apr;112(4):1207-14. doi: 10.1007/s00421-011-2073-2. Epub 2011 Jul 17.
- Results publication: PubMed 21210148Giordano P, Del Vecchio GC, Cecinati V, Delvecchio M, Altomare M, De Palma F, De Mattia D, Cavallo L, Faienza MF. Metabolic, inflammatory, endothelial and haemostatic markers in a group of Italian obese children and adolescents. Eur J Pediatr. 2011 Jul;170(7):845-50. doi: 10.1007/s00431-010-1356-7. Epub 2011 Jan 6.
- Results publication: PubMed 18930229Hopkins ND, Stratton G, Tinken TM, McWhannell N, Ridgers ND, Graves LE, George K, Cable NT, Green DJ. Relationships between measures of fitness, physical activity, body composition and vascular function in children. Atherosclerosis. 2009 May;204(1):244-9. doi: 10.1016/j.atherosclerosis.2008.09.004. Epub 2008 Sep 9.
- Results publication: PubMed 15580192Kelly AS, Wetzsteon RJ, Kaiser DR, Steinberger J, Bank AJ, Dengel DR. Inflammation, insulin, and endothelial function in overweight children and adolescents: the role of exercise. J Pediatr. 2004 Dec;145(6):731-6. doi: 10.1016/j.jpeds.2004.08.004.
- Results publication: PubMed 17481381McMurray RG, Zaldivar F, Galassetti P, Larson J, Eliakim A, Nemet D, Cooper DM. Cellular immunity and inflammatory mediator responses to intense exercise in overweight children and adolescents. J Investig Med. 2007 Apr;55(3):120-9. doi: 10.2310/6650.2007.06031.
- Results publication: PubMed 17084264Meyer AA, Kundt G, Lenschow U, Schuff-Werner P, Kienast W. Improvement of early vascular changes and cardiovascular risk factors in obese children after a six-month exercise program. J Am Coll Cardiol. 2006 Nov 7;48(9):1865-70. doi: 10.1016/j.jacc.2006.07.035. Epub 2006 Oct 17.
- Results publication: PubMed 21331062Norris AL, Steinberger J, Steffen LM, Metzig AM, Schwarzenberg SJ, Kelly AS. Circulating oxidized LDL and inflammation in extreme pediatric obesity. Obesity (Silver Spring). 2011 Jul;19(7):1415-9. doi: 10.1038/oby.2011.21. Epub 2011 Feb 17.
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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.
Ihuoma Eneli, MD principal investigator
Nationwide Children's Hospital
Andrea Bonny, MD principal investigator
Nationwide Children's Hospital
Robert Hoffman, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate exercise and High Intensity Interval Exercise in people with Childhood Obesity and Inflammation, run by Nationwide Children's Hospital 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 2 inclusion and 7 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 24 Apr 2015. 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?
Inflammation and endothelial function measured via forearm vascular resistance (FVR) and blood markers including tumor necrosis factor alpha (TNF-a), interleukin-6 (IL-6), adiponectin, high sensitivity C-reactive protein (hsCRP), and endothelin 1. (time frame: Within one month pre and one month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01821313, which also lists 14 linked publications.
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 24 Apr 2015.