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Cardiovascular Risk Factors in Overweight Adolescents

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Multitreatment approach
Aerobic interval training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Exercise Training, Cardiovascular diseases, Risk factors

Eligibility Criteria

13 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aerobic interval training

Multitreatment approach

Arm Description

Aerobic interval training (AIT)

multitreatment approach (MTG)

Outcomes

Primary Outcome Measures

VO2max change
maximal oxygen uptake change

Secondary Outcome Measures

Cardiovascular risk factors
endothelial function change
measured as FMD (flow-mediated dilution) using high-resolution vascular ultrasound

Full Information

First Posted
September 13, 2005
Last Updated
March 29, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00184236
Brief Title
Cardiovascular Risk Factors in Overweight Adolescents
Official Title
Aerobic Interval Training Reduces Cardiovascular Risk Factors More Than a Multitreatment Approach in Overweight Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2005 (Actual)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Exercise Training, Cardiovascular diseases, Risk factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic interval training
Arm Type
Active Comparator
Arm Description
Aerobic interval training (AIT)
Arm Title
Multitreatment approach
Arm Type
Active Comparator
Arm Description
multitreatment approach (MTG)
Intervention Type
Behavioral
Intervention Name(s)
Multitreatment approach
Other Intervention Name(s)
multidisciplinary approach
Intervention Description
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%
Intervention Type
Behavioral
Intervention Name(s)
Aerobic interval training
Intervention Description
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.
Primary Outcome Measure Information:
Title
VO2max change
Description
maximal oxygen uptake change
Time Frame
3 months and 12 months
Secondary Outcome Measure Information:
Title
Cardiovascular risk factors
Time Frame
2 years
Title
endothelial function change
Description
measured as FMD (flow-mediated dilution) using high-resolution vascular ultrasound
Time Frame
3 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Wisløff, PhD prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
The Norwegian University of Science and Technology
City
Trondheim
State/Province
Sør-Trøndelag
ZIP/Postal Code
7030
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18673303
Citation
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.
Results Reference
result
PubMed Identifier
20819968
Citation
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.
Results Reference
result

Learn more about this trial

Cardiovascular Risk Factors in Overweight Adolescents

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