NCT00184236

Brief Summary

The aim of the present study was to determine the effects of either a multidisciplinary approach or intensity-controlled interval training on cardiovascular risk factors in overweight adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

March 29, 2017

Conditions

OverweightObesity

Keywords

Exercise TrainingCardiovascular diseasesRisk factors

Outcome Measures

Primary Outcomes (1)

  • VO2max change

    maximal oxygen uptake change

    3 months and 12 months

Secondary Outcomes (2)

  • Cardiovascular risk factors

    2 years

  • endothelial function change

    3 months and 12 months

Study Arms (2)

Aerobic interval training

ACTIVE COMPARATOR

Aerobic interval training (AIT)

Behavioral: Aerobic interval training

Multitreatment approach

ACTIVE COMPARATOR

multitreatment approach (MTG)

Behavioral: Multitreatment approach

Interventions

Multitreatment approachBEHAVIORAL

12 months regimen consisting of group meetings every 2 weeks involving a physician, psychologist, physiotherapist and clinical nutritional physiologist. 21 h treatment during the first 3 months: 3 activity sessions (3 h) and 3 group conversations (4 h). Attendance inclusion criterium was set to minimum of 80%

Also known as: multidisciplinary approach
Multitreatment approach
Aerobic interval trainingBEHAVIORAL

Walking/running 'uphill' on a treadmill twice a week for 3 months. 10 min warming-up at 70% of Hfmax before performing 4x4 intervals at 90-95% of Hfmax. 3 min active recovery at 70% of Hfmax between each interval. 5 min cool-down period, giving a total of 40 min.

Aerobic interval training

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Overweight and obese adolescents in the Trondheim area, referred to medical treatment at St. Olav's Hospital

You may not qualify if:

  • Any coexisting medical illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Norwegian University of Science and Technology

Trondheim, Sør-Trøndelag, 7030, Norway

Location

Related Publications (2)

  • Tjonna AE, Stolen TO, Bye A, Volden M, Slordahl SA, Odegard R, Skogvoll E, Wisloff U. Aerobic interval training reduces cardiovascular risk factors more than a multitreatment approach in overweight adolescents. Clin Sci (Lond). 2009 Feb;116(4):317-26. doi: 10.1042/CS20080249.

    PMID: 18673303RESULT

  • Ingul CB, Tjonna AE, Stolen TO, Stoylen A, Wisloff U. Impaired cardiac function among obese adolescents: effect of aerobic interval training. Arch Pediatr Adolesc Med. 2010 Sep;164(9):852-9. doi: 10.1001/archpediatrics.2010.158.

    PMID: 20819968RESULT

MeSH Terms

Conditions

OverweightObesityCardiovascular Diseases

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ulrik Wisløff, PhD prof

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

February 1, 2005

Primary Completion

February 1, 2008

Study Completion

May 1, 2008

Last Updated

March 30, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)