NCT01991106

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable obesity

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

3.4 years

First QC Date

November 18, 2013

Last Update Submit

February 19, 2018

Conditions

Obesity

Keywords

ExerciseMyocardial functionVascular functionCardiovascular disease/prevention & controlPaediatric obesityVisceral adipose tissue

Outcome Measures

Primary Outcomes (1)

  • Peak systolic tissue velocity

    systolic tissue Doppler velocity assessed during resting and stress echocardiography

    12 weeks

Secondary Outcomes (13)

  • Subcutaneous and total abdominal adipose tissue

    12 weeks, 12 months

  • Cardiorespiratory fitness (VO2peak)

    12 weeks, 12 months

  • Body composition

    12 weeks, 12 months

  • Blood biochemistry

    12 weeks, 12 months

  • Physical activity

    12 weeks, 12 months

  • +8 more secondary outcomes

Study Arms (4)

High intensity interval training

EXPERIMENTAL

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 trainingDietary Supplement: Nutritional advice

Moderate intensity continuous training

EXPERIMENTAL

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

Behavioral: Moderate intensity continuous trainingDietary Supplement: Nutritional advice

nutritional advice

ACTIVE COMPARATOR

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

non-obese children

NO INTERVENTION

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

Interventions

High intensity interval trainingBEHAVIORAL

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

Also known as: HIIT
High intensity interval training
Moderate intensity continuous trainingBEHAVIORAL

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

Also known as: MICT
Moderate intensity continuous training
Nutritional adviceDIETARY_SUPPLEMENT

healthy food choices, portion sizes and regular mealtimes

High intensity interval trainingModerate intensity continuous trainingnutritional advice

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Queensland

Brisbane, Australia

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (5)

  • 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.

    PMID: 27044585BACKGROUND

  • 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.

    PMID: 28853029RESULT

  • 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.

    PMID: 29452134RESULT

  • 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.

    PMID: 31781386DERIVED

  • 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.

    PMID: 28372865DERIVED

MeSH Terms

Conditions

ObesityMotor ActivityCardiovascular Diseases

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ulrik Wisløff, prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

February 20, 2018

Record last verified: 2018-02

Locations

AU(1)NO(1)