Cardiovascular Risk Factors in Overweight Adolescents

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184236
First received: September 13, 2005
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

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 Intervention
Overweight
Obesity
Behavioral: Multitreatment approach
Behavioral: Aerobic intervention training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aerobic Interval Training Reduces Cardiovascular Risk Factors More Than a Multitreatment Approach in Overweight Adolescents

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • VO2max change [ Time Frame: 3 months and 12 months ] [ Designated as safety issue: No ]
    maximal oxygen uptake change


Secondary Outcome Measures:
  • Cardiovascular risk factors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • endothelial function change [ Time Frame: 3 months and 12 months ] [ Designated as safety issue: No ]
    measured as FMD (flow-mediated dilution) using high-resolution vascular ultrasound


Enrollment: 54
Study Start Date: February 2005
Study Completion Date: May 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AIT
Aerobic interval training
Behavioral: Aerobic intervention 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: MTG
multidisciplinary approach
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: multidisciplinairy approach

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.

  Eligibility

Ages Eligible for Study:   13 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184236

Locations
Norway
The Norwegian University of Science and Technology
Trondheim, Sør-Trøndelag, Norway, 7030
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Chair: Ulrik Wisløff, Dr.Philos Norwegian University of Science and Technology, St. Olav's Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184236     History of Changes
Other Study ID Numbers: ts-aet01
Study First Received: September 13, 2005
Last Updated: October 31, 2011
Health Authority: Norway: Norwegian Social Science Data Services

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

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014