Cardiovascular Risk Factors in Overweight Adolescents

March 29, 2017 updated by: Norwegian University of Science and Technology

Aerobic Interval Training Reduces Cardiovascular Risk Factors More Than a Multitreatment Approach in Overweight Adolescents

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several approaches have been used to improve cardiovascular health status and quality of life in obese children and adolescents, without coming to a consensus decision. Recently, a few studies have determined the effects of exercise training and diet on endothelial function in overweight and obese children and adolescents. The main findings are that only a moderate amount of exercise training and diet changes improves or restores endothelial function. It is difficult, however, to asses the separate effects of the training and diet, particularly because none of the studies have used a homogenous exercise training regimen. Unanimously, better, but affordable prevention and treatment strategies to improve wide-scale health outcome are called upon to slow down the current epidemic of overweight. It is now well established that physical activity reduces, but does not currently prevent the epidemic of obesity from either reaching global proportions or taxing public health and economy. Despite the recent advances in understanding the responsible biology of improved cardiovascular health with exercise training, several lines of research questions are still unresolved. For instance, the optimal program, e.g. when to initiate, whom to prescribe exercise to, which exercise-intensity is required, and the actual design of the treatment program, remain by far yet to determine.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Sør-Trøndelag
      • Trondheim, Sør-Trøndelag, Norway, 7030
        • The Norwegian University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Any coexisting medical illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aerobic interval training
Aerobic interval training (AIT)
Behavioral: Aerobic interval training
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.
Active Comparator: Multitreatment approach
multitreatment approach (MTG)
Behavioral: Multitreatment approach
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%
Other Names:
  • multidisciplinary approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2max change
Time Frame: 3 months and 12 months
maximal oxygen uptake change
3 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular risk factors
Time Frame: 2 years
2 years
endothelial function change
Time Frame: 3 months and 12 months
measured as FMD (flow-mediated dilution) using high-resolution vascular ultrasound
3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Chair: Ulrik Wisløff, PhD prof, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ts-aet01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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