NCT00205296

Brief Summary

We hypothesize that improvement in cardiovascular fitness is associated with a greater improvement in insulin sensitivity than improvement in body composition (loss of body fat) is associated with insulin sensitivity. Towards that we are randomizing children who are overweight, or children with low fitness levels to exercise intervention 2 or three times per week.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Mar 2002

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2008

Enrollment Period

10.8 years

First QC Date

September 12, 2005

Last Update Submit

October 1, 2015

Conditions

ObesityLow Fitness

Outcome Measures

Primary Outcomes (1)

  • maximal VO2 levels

    9 months

Secondary Outcomes (1)

  • fasting insulin and glucose levels

    9 months

Interventions

exerciseBEHAVIORAL

this will test the effect of exercise on insulin sensitivity, fitness and body composition

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • obesity
  • low fitness

You may not qualify if:

  • diagnosis of diabetes
  • inability to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aaron Carrel, MD, MPH

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2002

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 2, 2015

Record last verified: 2008-10

Locations

US(1)