Cardiovascular Risk Factors in Overweight Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00184236
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 30, 2017
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Multitreatment approach Behavioral: Aerobic interval training Not Applicable

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  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aerobic Interval Training Reduces Cardiovascular Risk Factors More Than a Multitreatment Approach in Overweight Adolescents
Actual Study Start Date : February 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : May 2008

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 Name: multidisciplinary approach

Primary Outcome Measures :
  1. VO2max change [ Time Frame: 3 months and 12 months ]
    maximal oxygen uptake change

Secondary Outcome Measures :
  1. Cardiovascular risk factors [ Time Frame: 2 years ]
  2. endothelial function change [ Time Frame: 3 months and 12 months ]
    measured as FMD (flow-mediated dilution) using high-resolution vascular ultrasound

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00184236

The Norwegian University of Science and Technology
Trondheim, Sør-Trøndelag, Norway, 7030
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Study Chair: Ulrik Wisløff, PhD prof Norwegian University of Science and Technology

Publications of Results:
Responsible Party: Norwegian University of Science and Technology Identifier: NCT00184236     History of Changes
Other Study ID Numbers: ts-aet01
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Exercise Training
Cardiovascular diseases
Risk factors

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms