ObesityNCT01991106
Effects of Exercise Intensity in Obese Children and Adolescents
A study testing High intensity interval training, Moderate intensity continuous training and Nutritional advice in people with Obesity, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
Trial summary
The prevalence of paediatric obesity has increased over the last two decades and with it, an increased diagnosis of lifestyle-related diseases in children and adolescents. High intensity interval training has recently been explored as an alternate to traditional aerobic exercise in adults with chronic disease and has… Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Obesity
- What is being tested?
- High intensity interval training, Moderate intensity continuous training and Nutritional advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2013to 31 Mar 2017
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Obese (BMI ≥ 95th percentile - age and sex specific criteria)
Who cannot join
- Elevated blood pressure (≥ 95th percentile for systolic or diastolic values)
- Congenital heart disease
- Coronary artery disease
- Family history of hypertropic obstructive cardiomyopathy
- Any abnormality during rest or stress echocardiography which indicates it would be unsafe to participate
- Self reported kidney failure
Show all 15Show fewer
- Any major organ transplant
- Considerable pulmonary disease including severe or poorly controlled asthma
- Smoking
- Diabetes
- Epilepsy or a history of seizures
- Orthopaedic or neurological limitations to exercise
- Diagnosed attention deficit hypersensitivity disorder
- Steroid medications
- Participation in another research study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multi-centre Randomized Controlled Trial Examining the Effects of High Intensity Interval Training on Cardio-metabolic Outcomes in Obese Children and Adolescents
The prevalence of paediatric obesity has increased over the last two decades and with it, an increased diagnosis of lifestyle-related diseases in children and adolescents. High intensity interval training has recently been explored as an alternate to traditional aerobic exercise in adults with chronic disease and has potential to induce rapid reversal of subclinical disease markers in obese children and adolescents.
High intensity interval training has recently been explored as an alternate to traditional aerobic exercise in adults with chronic disease and has potential to induce rapid reversal of subclinical disease markers in obese children and adolescents.
Read more
Goal: The primary aim of this randomised controlled trial is to evaluate the effectiveness of a high intensity interval training intervention on myocardial function, vascular function and visceral adipose tissue in obese children and adolescents at baseline, three and twelve months.
Method: Multi-centre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). Participants will be randomised to (1) high intensity interval training, (2) moderate intensity continuous training or (3) nutrition advise. Participants will partake in supervised exercise training and/or nutrition consultations for 3 months. Measurements for all study endpoints will occur at baseline, 3 months (post intervention) and 12 months (follow up).
Scientific Significance : This randomised controlled trial will general substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardio-metabolic health of this at-risk population. It is expected that communication of results will allow for more robust and realistic guidelines regarding exercise prescription in this population to be formed while outlining the benefits of high intensity interval training on subclinical markers of disease.
Read the detailed description
Worldwide, childhood overweight and obesity rates are approximately 10%, this high incidence attributed to a physically inactive lifestyle and inappropriate nutrition. Early cohort studies illustrated that fifty per cent of obese children became obese adults and consequently had an higher risk for metabolic syndrome than obese adults who were not obese as children. Both female and male overweight children and adolescents had a 30% increase in all cause mortality. The increases in risk of death were independent of adult body mass index.
Systematic reviews suggest that lifestyle and exercise interventions in obese children and adolescents can lead to improvements in anthropometric and cardio-metabolic outcomes, but these are not inclusive of several important outcomes such as myocardial and vascular function or visceral adipose tissue.
- Conditions
- Obesity
- Being tested
- High intensity interval training, Moderate intensity continuous training, Nutritional advice
- Keywords
- Exercise, Myocardial function, Vascular function, Cardiovascular disease/prevention & control, Paediatric obesity, Visceral adipose tissue
- Medical subject headings
- Obesity, Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingBehavioural
Also called HIIT
Twelve weeks of 2-3 supervised training sessions each week.
Moderate intensity continuous trainingBehavioural
Also called MICT
Twelve weeks of 2-3 supervised training sessions each week.
Nutritional adviceDietary supplement
healthy food choices, portion sizes and regular mealtimes
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Experimental | 10-minute warm up at 60-70% of maximal heart rate (HRmax). Then walking, running or cycling at 85-95% of maximal heart rate at intervals of 4 x 4 minutes, with 3 minute active breaks (50-70% of HRmax) between intervals. A 5-minute cool down period. Receives: Behavioral: High intensity interval training; Dietary Supplement: Nutritional advice |
| Moderate intensity continuous training | Experimental | walking, running or cycling continuously at 60-70% HRmax for 44 minutes. Receives: Behavioral: Moderate intensity continuous training; Dietary Supplement: Nutritional advice |
| nutritional advice | Active comparator | 10 individual nutrition consultations with an accredited dietitian over the 12 month period. Content of consultations will include healthy food choices, portion sizes and regular mealtimes. Receives: Dietary Supplement: Nutritional advice |
| non-obese children | No intervention | 100 healthy non-obese children aged 7-16 (controls) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak systolic tissue velocity
systolic tissue Doppler velocity assessed during resting and stress echocardiography
Measured: 12 weeks
Secondary outcomes (13)
Subcutaneous and total abdominal adipose tissue
Assessed using MRI
Measured: 12 weeks, 12 months
Cardiorespiratory fitness (VO2peak)
Assessed using a maximal treadmill test
Measured: 12 weeks, 12 months
Body composition
Assessed using DXA (UQ), BodPod (NTNU)
Measured: 12 weeks, 12 months
Blood biochemistry
Analysed for lipids, glucose, insulin, inflammatory makers, satiety hormones, oxidative stress
Measured: 12 weeks, 12 months
Physical activity
Assessed through 7 day accelerometry
Measured: 12 weeks, 12 months
Dietary analysis
Assessed through a three-day food record
Measured: 12 weeks, 12 months
Myocardial structure and cardiac adipose tissue (UQ)
Assessed through cardiac MRI; participants > 12 years only
Measured: 12 weeks
Arterial stiffness
Assessed through pulse wave velocity and pulse wave analysis
Measured: 12 weeks, 12 months
Autonomic function
Assessed through heart rate variability and heart rate recovery
Measured: 12 weeks, 12 months
Quality of life
Assessed through the Paediatric Quality of Life Inventory
Measured: 12 weeks, 12 months
Visceral adipose tissue
assessed by magnetic resonance imaging (MRI)
Measured: 12 weeks, 12 months
Vascular function
Assessed through flow mediated dilation procedure
Measured: 12 weeks, 12 months
Peak systolic tissue velocity
systolic tissue Doppler velocity assessed during resting and stress echocardiography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991106
- Sponsor's protocol ID
- 2009/1313
- Status last verified
- Feb 2018
- First submitted
- 18 Nov 2013
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dias KA, Coombes JS, Green DJ, Gomersall SR, Keating SE, Tjonna AE, Hollekim-Strand SM, Hosseini MS, Ro TB, Haram M, Huuse EM, Davies PS, Cain PA, Leong GM, Ingul CB. Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol. BMJ Open. 2016 Apr 4;6(4):e010929. doi: 10.1136/bmjopen-2015-010929.
PubMed 27044585Dias KA, Ingul CB, Tjonna AE, Keating SE, Gomersall SR, Follestad T, Hosseini MS, Hollekim-Strand SM, Ro TB, Haram M, Huuse EM, Davies PSW, Cain PA, Leong GM, Coombes JS. Effect of High-Intensity Interval Training on Fitness, Fat Mass and Cardiometabolic Biomarkers in Children with Obesity: A Randomised Controlled Trial. Sports Med. 2018 Mar;48(3):733-746. doi: 10.1007/s40279-017-0777-0.
PubMed 28853029Ingul CB, Dias KA, Tjonna AE, Follestad T, Hosseini MS, Timilsina AS, Hollekim-Strand SM, Ro TB, Davies PSW, Cain PA, Leong GM, Coombes JS. Effect of High Intensity Interval Training on Cardiac Function in Children with Obesity: A Randomised Controlled Trial. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):214-221. doi: 10.1016/j.pcad.2018.01.012. Epub 2018 Feb 13.
PubMed 29452134Dias KA, Ramos JS, Wallen MP, Davies PSW, Cain PA, Leong GM, Ingul CB, Coombes JS, Keating SE. Accuracy of Longitudinal Assessment of Visceral Adipose Tissue by Dual-Energy X-Ray Absorptiometry in Children with Obesity. J Obes. 2019 Nov 3;2019:2193723. doi: 10.1155/2019/2193723. eCollection 2019.
PubMed 31781386Dias KA, Spence AL, Sarma S, Oxborough D, Timilsina AS, Davies PSW, Cain PA, Leong GM, Ingul CB, Coombes JS. Left ventricular morphology and function in adolescents: Relations to fitness and fatness. Int J Cardiol. 2017 Aug 1;240:313-319. doi: 10.1016/j.ijcard.2017.03.047. Epub 2017 Mar 11.
PubMed 28372865
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Randomized Controlled Trial Examining the Effects of High Intensity Interval Training on Cardio-metabolic Outcomes in Obese Children and Adolescents
- ClinicalTrials.gov ID
- NCT01991106
- Acronym / sponsor ID
- 2009/1313
- Conditions
- Obesity
- Keywords
- Exercise, Myocardial function, Vascular function, Cardiovascular disease/prevention & control, Paediatric obesity, Visceral adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The University of Queensland
- Study start
- Nov 2013 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 25 Nov 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 prevalence of paediatric obesity has increased over the last two decades and with it, an increased diagnosis of lifestyle-related diseases in children and adolescents. High intensity interval training has recently been explored as an alternate to traditional aerobic exercise in adults with chronic disease and has potential to induce rapid reversal of subclinical disease markers in obese children and adolescents.
High intensity interval training has recently been explored as an alternate to traditional aerobic exercise in adults with chronic disease and has potential to induce rapid reversal of subclinical disease markers in obese children and adolescents.
Goal: The primary aim of this randomised controlled trial is to evaluate the effectiveness of a high intensity interval training intervention on myocardial function, vascular function and visceral adipose tissue in obese children and adolescents at baseline, three and twelve months.
Method: Multi-centre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). Participants will be randomised to (1) high intensity interval training, (2) moderate intensity continuous training or (3) nutrition advise. Participants will partake in supervised exercise training and/or nutrition consultations for 3 months. Measurements for all study endpoints will occur at baseline, 3 months (post intervention) and 12 months (follow up).
Scientific Significance : This randomised controlled trial will general substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardio-metabolic health of this at-risk population. It is expected that communication of results will allow for more robust and realistic guidelines regarding exercise prescription in this population to be formed while outlining the benefits of high intensity interval training on subclinical markers of disease.
Detailed description
Worldwide, childhood overweight and obesity rates are approximately 10%, this high incidence attributed to a physically inactive lifestyle and inappropriate nutrition. Early cohort studies illustrated that fifty per cent of obese children became obese adults and consequently had an higher risk for metabolic syndrome than obese adults who were not obese as children. Both female and male overweight children and adolescents had a 30% increase in all cause mortality. The increases in risk of death were independent of adult body mass index.
Systematic reviews suggest that lifestyle and exercise interventions in obese children and adolescents can lead to improvements in anthropometric and cardio-metabolic outcomes, but these are not inclusive of several important outcomes such as myocardial and vascular function or visceral adipose tissue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training | Experimental | Behavioral: High intensity interval training, Dietary Supplement: Nutritional advice10-minute warm up at 60-70% of maximal heart rate (HRmax). Then walking, running or cycling at 85-95% of maximal heart rate at intervals of 4 x 4 minutes, with 3 minute active breaks (50-70% of HRmax) between intervals. A 5-minute cool down period. |
| Moderate intensity continuous training | Experimental | Behavioral: Moderate intensity continuous training, Dietary Supplement: Nutritional advicewalking, running or cycling continuously at 60-70% HRmax for 44 minutes. |
| nutritional advice | Active comparator | Dietary Supplement: Nutritional advice10 individual nutrition consultations with an accredited dietitian over the 12 month period. Content of consultations will include healthy food choices, portion sizes and regular mealtimes. |
| non-obese children | No intervention | –100 healthy non-obese children aged 7-16 (controls) |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Obese (BMI ≥ 95th percentile - age and sex specific criteria)
Key exclusion criteria (15 listed)
- Elevated blood pressure (≥ 95th percentile for systolic or diastolic values)
- Congenital heart disease
- Coronary artery disease
- Family history of hypertropic obstructive cardiomyopathy
- Any abnormality during rest or stress echocardiography which indicates it would be unsafe to participate
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 trainingAlso: HIITTwelve weeks of 2-3 supervised training sessions each week. | Behavioural | High intensity interval training |
| Moderate intensity continuous trainingAlso: MICTTwelve weeks of 2-3 supervised training sessions each week. | Behavioural | Moderate intensity continuous training |
| Nutritional advicehealthy food choices, portion sizes and regular mealtimes | Dietary supplement | High intensity interval training, Moderate intensity continuous training, nutritional advice |
Primary outcome
Peak systolic tissue velocity
Time frame: 12 weeks
systolic tissue Doppler velocity assessed during resting and stress echocardiography
13 secondary outcomes
Subcutaneous and total abdominal adipose tissue
Time frame: 12 weeks, 12 months
Cardiorespiratory fitness (VO2peak)
Time frame: 12 weeks, 12 months
Body composition
Time frame: 12 weeks, 12 months
Blood biochemistry
Time frame: 12 weeks, 12 months
Physical activity
Time frame: 12 weeks, 12 months
Dietary analysis
Time frame: 12 weeks, 12 months
Myocardial structure and cardiac adipose tissue (UQ)
Time frame: 12 weeks
Arterial stiffness
Time frame: 12 weeks, 12 months
Autonomic function
Time frame: 12 weeks, 12 months
Quality of life
Time frame: 12 weeks, 12 months
Visceral adipose tissue
Time frame: 12 weeks, 12 months
Vascular function
Time frame: 12 weeks, 12 months
Peak systolic tissue velocity
Time frame: 12 months
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 20 Feb 2018.
- Background: PubMed 27044585Dias KA, Coombes JS, Green DJ, Gomersall SR, Keating SE, Tjonna AE, Hollekim-Strand SM, Hosseini MS, Ro TB, Haram M, Huuse EM, Davies PS, Cain PA, Leong GM, Ingul CB. Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol. BMJ Open. 2016 Apr 4;6(4):e010929. doi: 10.1136/bmjopen-2015-010929.
- Results publication: PubMed 28853029Dias KA, Ingul CB, Tjonna AE, Keating SE, Gomersall SR, Follestad T, Hosseini MS, Hollekim-Strand SM, Ro TB, Haram M, Huuse EM, Davies PSW, Cain PA, Leong GM, Coombes JS. Effect of High-Intensity Interval Training on Fitness, Fat Mass and Cardiometabolic Biomarkers in Children with Obesity: A Randomised Controlled Trial. Sports Med. 2018 Mar;48(3):733-746. doi: 10.1007/s40279-017-0777-0.
- Results publication: PubMed 29452134Ingul CB, Dias KA, Tjonna AE, Follestad T, Hosseini MS, Timilsina AS, Hollekim-Strand SM, Ro TB, Davies PSW, Cain PA, Leong GM, Coombes JS. Effect of High Intensity Interval Training on Cardiac Function in Children with Obesity: A Randomised Controlled Trial. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):214-221. doi: 10.1016/j.pcad.2018.01.012. Epub 2018 Feb 13.
- Derived from this study: PubMed 31781386Dias KA, Ramos JS, Wallen MP, Davies PSW, Cain PA, Leong GM, Ingul CB, Coombes JS, Keating SE. Accuracy of Longitudinal Assessment of Visceral Adipose Tissue by Dual-Energy X-Ray Absorptiometry in Children with Obesity. J Obes. 2019 Nov 3;2019:2193723. doi: 10.1155/2019/2193723. eCollection 2019.
- Derived from this study: PubMed 28372865Dias KA, Spence AL, Sarma S, Oxborough D, Timilsina AS, Davies PSW, Cain PA, Leong GM, Ingul CB, Coombes JS. Left ventricular morphology and function in adolescents: Relations to fitness and fatness. Int J Cardiol. 2017 Aug 1;240:313-319. doi: 10.1016/j.ijcard.2017.03.047. Epub 2017 Mar 11.
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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.
Ulrik Wisløff, prof study director
Norwegian University of Science and Technology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training, Moderate intensity continuous training and Nutritional advice in people with Obesity, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
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 1 inclusion and 15 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Norway. 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?
Peak systolic tissue velocity (time frame: 12 weeks). 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 NCT01991106, which also lists 5 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 20 Feb 2018.