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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01991106




Registration number
NCT01991106
Ethics application status
Date submitted
18/11/2013
Date registered
25/11/2013
Date last updated
20/02/2018

Titles & IDs
Public title
Effects of Exercise Intensity in Obese Children and Adolescents
Scientific title
A Multi-centre Randomized Controlled Trial Examining the Effects of High Intensity Interval Training on Cardio-metabolic Outcomes in Obese Children and Adolescents
Secondary ID [1] 0 0
2009/1313
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - High intensity interval training
Behaviour - Moderate intensity continuous training
Other interventions - Nutritional advice

Experimental: High intensity interval training - 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.

Experimental: Moderate intensity continuous training - walking, running or cycling continuously at 60-70% HRmax for 44 minutes.

Active Comparator: nutritional advice - 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.

No Intervention: non-obese children - 100 healthy non-obese children aged 7-16 (controls)


Behaviour: High intensity interval training
Twelve weeks of 2-3 supervised training sessions each week.

Behaviour: Moderate intensity continuous training
Twelve weeks of 2-3 supervised training sessions each week.

Other interventions: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
Intervention code [1] 0 0
Behaviour
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Peak systolic tissue velocity
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Subcutaneous and total abdominal adipose tissue
Timepoint [1] 0 0
12 weeks, 12 months
Secondary outcome [2] 0 0
Cardiorespiratory fitness (VO2peak)
Timepoint [2] 0 0
12 weeks, 12 months
Secondary outcome [3] 0 0
Body composition
Timepoint [3] 0 0
12 weeks, 12 months
Secondary outcome [4] 0 0
Blood biochemistry
Timepoint [4] 0 0
12 weeks, 12 months
Secondary outcome [5] 0 0
Physical activity
Timepoint [5] 0 0
12 weeks, 12 months
Secondary outcome [6] 0 0
Dietary analysis
Timepoint [6] 0 0
12 weeks, 12 months
Secondary outcome [7] 0 0
Myocardial structure and cardiac adipose tissue (UQ)
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Arterial stiffness
Timepoint [8] 0 0
12 weeks, 12 months
Secondary outcome [9] 0 0
Autonomic function
Timepoint [9] 0 0
12 weeks, 12 months
Secondary outcome [10] 0 0
Quality of life
Timepoint [10] 0 0
12 weeks, 12 months
Secondary outcome [11] 0 0
Visceral adipose tissue
Timepoint [11] 0 0
12 weeks, 12 months
Secondary outcome [12] 0 0
Vascular function
Timepoint [12] 0 0
12 weeks, 12 months
Secondary outcome [13] 0 0
Peak systolic tissue velocity
Timepoint [13] 0 0
12 months

Eligibility
Key inclusion criteria
- Obese (BMI = 95th percentile - age and sex specific criteria)
Minimum age
7 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2017
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
Norway
State/province [1] 0 0
Trondheim

Funding & Sponsors
Primary sponsor type
Other
Name
Norwegian University of Science and Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Queensland
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01991106
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Ulrik Wisløff, prof
Address 0 0
Norwegian University of Science and Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01991106