At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 222 enrolled

Drug / intervention

Aerobic exercise programbehavioral

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00108901

NCT00108901Phase 2Completed

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Exercise Dose and Insulin Sensitivity in Obese Children

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Apr 21, 2005·Updated Dec 24, 2014

In Brief

A Phase 2 clinical trial evaluating Aerobic exercise program for Obesity and 2 related conditions. Completed, enrolled 222 participants across 1 site.

Detailed Summary

The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other cardiovascular risk factors in overweight elementary schoolchildren. The hypothesis is that the more exercise a child does, the more benefit he or she will gain in reducing the risk of diabetes and other cardiovascular diseases. An ancillary study examined effects on cognition and achievement.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsObesity, Type 2 Diabetes Prevention, Executive Function (Cognition)

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2003

First PostedApr 2005

Primary CompletionDec 2006

Study CompletionJan 2007

TodayJul 2026

First PostedApr 21, 2005

Enrollment StartJun 1, 2003

Primary CompletionDec 1, 2006

Study CompletionJan 1, 2007

TodayJul 2, 2026

Enrollment to primary: 3.5 yearsPosted 21.2 years ago

Interventions

Aerobic exercise programbehavioral

Vigorous intermittent physical activity in group format conducted in research gymnasium after school by research staff. Heart rate monitors documented each child's average heart rate on a daily basis. Small incentives were offered for achieving goal of \>150 bpm average HR each day and attending at least 80% of sessions (4 days/week).