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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
BEHAVIORAL - High intensity interval training
BEHAVIORAL - Moderate intensity continuous training
Treatment: Other - 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)


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

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

Treatment: Other: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Treatment: Other
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
NA
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT01991106