Cardiovascular Risk Factors in Overweight Adolescents

NCT ID: NCT00184236

Last Updated: 2017-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aerobic interval training

Aerobic interval training (AIT)

Group Type ACTIVE_COMPARATOR

Aerobic interval training

Intervention Type BEHAVIORAL

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.

Multitreatment approach

multitreatment approach (MTG)

Group Type ACTIVE_COMPARATOR

Multitreatment approach

Intervention Type BEHAVIORAL

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%

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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%

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

multidisciplinary approach

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ulrik Wisløff, PhD prof

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Norwegian University of Science and Technology

Trondheim, Sør-Trøndelag, Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18673303 (View on PubMed)

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.

Reference Type RESULT
PMID: 20819968 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ts-aet01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Active With Heart Disease
NCT01624818 UNKNOWN EARLY_PHASE1