Effects of Exercise Intensity in Obese Children and Adolescents

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991106
• Other study ID #: 2009/1313
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: February 19, 2018
• Start date: November 2013
• Est. completion date: March 31, 2017

Study information

• Verified date: February 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• High intensity interval training
Twelve weeks of 2-3 supervised training sessions each week.
• Moderate intensity continuous training
Twelve weeks of 2-3 supervised training sessions each week.

Dietary Supplement:
• Nutritional advice
healthy food choices, portion sizes and regular mealtimes

Locations

Country	Name	City	State
Australia	University of Queensland	Brisbane
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	The University of Queensland

Countries where clinical trial is conducted

Australia,  Norway, 

References & Publications (3)

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. — View Citation

Dias KA, Ingul CB, Tjønna 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 — View Citation

Ingul 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 Tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak systolic tissue velocity	systolic tissue Doppler velocity assessed during resting and stress echocardiography	12 weeks
Secondary	Subcutaneous and total abdominal adipose tissue	Assessed using MRI	12 weeks, 12 months
Secondary	Cardiorespiratory fitness (VO2peak)	Assessed using a maximal treadmill test	12 weeks, 12 months
Secondary	Body composition	Assessed using DXA (UQ), BodPod (NTNU)	12 weeks, 12 months
Secondary	Blood biochemistry	Analysed for lipids, glucose, insulin, inflammatory makers, satiety hormones, oxidative stress	12 weeks, 12 months
Secondary	Physical activity	Assessed through 7 day accelerometry	12 weeks, 12 months
Secondary	Dietary analysis	Assessed through a three-day food record	12 weeks, 12 months
Secondary	Myocardial structure and cardiac adipose tissue (UQ)	Assessed through cardiac MRI; participants > 12 years only	12 weeks
Secondary	Arterial stiffness	Assessed through pulse wave velocity and pulse wave analysis	12 weeks, 12 months
Secondary	Autonomic function	Assessed through heart rate variability and heart rate recovery	12 weeks, 12 months
Secondary	Quality of life	Assessed through the Paediatric Quality of Life Inventory	12 weeks, 12 months
Secondary	Visceral adipose tissue	assessed by magnetic resonance imaging (MRI)	12 weeks, 12 months
Secondary	Vascular function	Assessed through flow mediated dilation procedure	12 weeks, 12 months
Secondary	Peak systolic tissue velocity	systolic tissue Doppler velocity assessed during resting and stress echocardiography	12 months