Effects of Exercise Intensity in Obese Children and Adolescents

February 19, 2018 updated by: Norwegian University of Science and Technology

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia
        • University of Queensland
  • Norway
      • Trondheim, Norway
        • St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Obese (BMI ≥ 95th percentile - age and sex specific criteria)

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: High intensity interval training
Twelve weeks of 2-3 supervised training sessions each week.
Other Names:
  • HIIT
Dietary supplement: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
Experimental: Moderate intensity continuous training
walking, running or cycling continuously at 60-70% HRmax for 44 minutes.
Dietary supplement: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
Behavioral: Moderate intensity continuous training
Twelve weeks of 2-3 supervised training sessions each week.
Other Names:
  • MICT
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.
Dietary supplement: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
No Intervention: non-obese children
100 healthy non-obese children aged 7-16 (controls)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak systolic tissue velocity
Time Frame: 12 weeks
systolic tissue Doppler velocity assessed during resting and stress echocardiography
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subcutaneous and total abdominal adipose tissue
Time Frame: 12 weeks, 12 months
Assessed using MRI
12 weeks, 12 months
Cardiorespiratory fitness (VO2peak)
Time Frame: 12 weeks, 12 months
Assessed using a maximal treadmill test
12 weeks, 12 months
Body composition
Time Frame: 12 weeks, 12 months
Assessed using DXA (UQ), BodPod (NTNU)
12 weeks, 12 months
Blood biochemistry
Time Frame: 12 weeks, 12 months
Analysed for lipids, glucose, insulin, inflammatory makers, satiety hormones, oxidative stress
12 weeks, 12 months
Physical activity
Time Frame: 12 weeks, 12 months
Assessed through 7 day accelerometry
12 weeks, 12 months
Dietary analysis
Time Frame: 12 weeks, 12 months
Assessed through a three-day food record
12 weeks, 12 months
Myocardial structure and cardiac adipose tissue (UQ)
Time Frame: 12 weeks
Assessed through cardiac MRI; participants > 12 years only
12 weeks
Arterial stiffness
Time Frame: 12 weeks, 12 months
Assessed through pulse wave velocity and pulse wave analysis
12 weeks, 12 months
Autonomic function
Time Frame: 12 weeks, 12 months
Assessed through heart rate variability and heart rate recovery
12 weeks, 12 months
Quality of life
Time Frame: 12 weeks, 12 months
Assessed through the Paediatric Quality of Life Inventory
12 weeks, 12 months
Visceral adipose tissue
Time Frame: 12 weeks, 12 months
assessed by magnetic resonance imaging (MRI)
12 weeks, 12 months
Vascular function
Time Frame: 12 weeks, 12 months
Assessed through flow mediated dilation procedure
12 weeks, 12 months
Peak systolic tissue velocity
Time Frame: 12 months
systolic tissue Doppler velocity assessed during resting and stress echocardiography
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian University of Science and Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Queensland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009/1313

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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