Effects of Exercise Intensity in Obese Children and Adolescents

NCT ID: NCT01991106

Last Updated: 2018-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

High intensity interval training

Intervention Type BEHAVIORAL

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

Nutritional advice

Intervention Type DIETARY_SUPPLEMENT

healthy food choices, portion sizes and regular mealtimes

Moderate intensity continuous training

walking, running or cycling continuously at 60-70% HRmax for 44 minutes.

Group Type EXPERIMENTAL

Moderate intensity continuous training

Intervention Type BEHAVIORAL

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

Nutritional advice

Intervention Type DIETARY_SUPPLEMENT

healthy food choices, portion sizes and regular mealtimes

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.

Group Type ACTIVE_COMPARATOR

Nutritional advice

Intervention Type DIETARY_SUPPLEMENT

healthy food choices, portion sizes and regular mealtimes

non-obese children

100 healthy non-obese children aged 7-16 (controls)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High intensity interval training

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

Intervention Type BEHAVIORAL

Moderate intensity continuous training

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

Intervention Type BEHAVIORAL

Nutritional advice

healthy food choices, portion sizes and regular mealtimes

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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HIIT MICT

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Queensland

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulrik Wisløff, prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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University of Queensland

Brisbane, , Australia

Site Status

St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Australia Norway

References

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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.

Reference Type BACKGROUND
PMID: 27044585 (View on PubMed)

Dias KA, Ingul CB, Tjonna 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 Biomarkers in Children with Obesity: A Randomised Controlled Trial. Sports Med. 2018 Mar;48(3):733-746. doi: 10.1007/s40279-017-0777-0.

Reference Type RESULT
PMID: 28853029 (View on PubMed)

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 Trial. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):214-221. doi: 10.1016/j.pcad.2018.01.012. Epub 2018 Feb 13.

Reference Type RESULT
PMID: 29452134 (View on PubMed)

Dias KA, Ramos JS, Wallen MP, Davies PSW, Cain PA, Leong GM, Ingul CB, Coombes JS, Keating SE. Accuracy of Longitudinal Assessment of Visceral Adipose Tissue by Dual-Energy X-Ray Absorptiometry in Children with Obesity. J Obes. 2019 Nov 3;2019:2193723. doi: 10.1155/2019/2193723. eCollection 2019.

Reference Type DERIVED
PMID: 31781386 (View on PubMed)

Dias KA, Spence AL, Sarma S, Oxborough D, Timilsina AS, Davies PSW, Cain PA, Leong GM, Ingul CB, Coombes JS. Left ventricular morphology and function in adolescents: Relations to fitness and fatness. Int J Cardiol. 2017 Aug 1;240:313-319. doi: 10.1016/j.ijcard.2017.03.047. Epub 2017 Mar 11.

Reference Type DERIVED
PMID: 28372865 (View on PubMed)

Other Identifiers

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2009/1313

Identifier Type: -

Identifier Source: org_study_id

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