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NCT Number: NCT01991106

Effects of Exercise Intensity 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.

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Key information

Conditions

Obesity Behavior Body Weight Cardiovascular Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Queensland, Brisbane, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Interval Training

Behavioral

Twelve weeks of 2-3 supervised training sessions each week.

Other names: HIIT

Moderate Intensity Continuous Training

Behavioral

Twelve weeks of 2-3 supervised training sessions each week.

Other names: MICT

Nutritional advice

Dietary Supplement

healthy food choices, portion sizes and regular mealtimes

Primary outcomes

  1. Peak systolic tissue velocity

    Time frame: 12 weeks

    systolic tissue Doppler velocity assessed during resting and stress echocardiography

Secondary outcomes

  1. Subcutaneous and total abdominal adipose tissue

    Time frame: 12 weeks, 12 months

    Assessed using MRI

  2. Cardiorespiratory fitness (VO2peak)

    Time frame: 12 weeks, 12 months

    Assessed using a maximal treadmill test

  3. Body composition

    Time frame: 12 weeks, 12 months

    Assessed using DXA (UQ), BodPod (NTNU)

  4. Blood biochemistry

    Time frame: 12 weeks, 12 months

    Analysed for lipids, glucose, insulin, inflammatory makers, satiety hormones, oxidative stress

  5. Physical activity

    Time frame: 12 weeks, 12 months

    Assessed through 7 day accelerometry

  6. Dietary analysis

    Time frame: 12 weeks, 12 months

    Assessed through a three-day food record

  7. Myocardial structure and cardiac adipose tissue (UQ)

    Time frame: 12 weeks

    Assessed through cardiac MRI; participants > 12 years only

  8. Arterial stiffness

    Time frame: 12 weeks, 12 months

    Assessed through pulse wave velocity and pulse wave analysis

  9. Autonomic function

    Time frame: 12 weeks, 12 months

    Assessed through heart rate variability and heart rate recovery

  10. Quality of life

    Time frame: 12 weeks, 12 months

    Assessed through the Paediatric Quality of Life Inventory

  11. Visceral adipose tissue

    Time frame: 12 weeks, 12 months

    assessed by magnetic resonance imaging (MRI)

  12. Vascular function

    Time frame: 12 weeks, 12 months

    Assessed through flow mediated dilation procedure

  13. Peak systolic tissue velocity

    Time frame: 12 months

    systolic tissue Doppler velocity assessed during resting and stress echocardiography

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • The University of Queensland

Registry information

Official study title

A Multi-centre Randomized Controlled Trial Examining the Effects of High Intensity Interval Training on Cardio-metabolic Outcomes in Obese Children and Adolescents

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2013
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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