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Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program

NCT01030978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-06-17

No results posted yet for this study

Summary

The purpose of this study is to determine if the Bright Bodies (BB) Healthy Lifestyle Program can help reverse early abnormalities in glucose metabolism and prevent the progression to type 2 diabetes (T2DM) in high-risk, obese youth with newly-diagnosed impaired glucose tolerance (IGT).

Conditions

  • Impaired Glucose Tolerance

Interventions

BEHAVIORAL

Bright Bodies Healthy Lifestyle Program

Subjects attend program with a caregiver or parent twice per week for 6 mos. Exercise is 2x/wk, behavior mod/nutrition 1 x/wk, and parent class 1 x/wk. Smart Moves curriculum is utilized for nutrition and behavior mod.

BEHAVIORAL

Control

Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Robert S. Sherwin, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01030978 on ClinicalTrials.gov