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

June 16, 2014 updated by: Yale University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Aim: (1) To determine whether youth randomized to the Bright Bodies (BB) Healthy Lifestyle Program have lower 2-hr plasma glucose levels than those randomized to standard lifestyle counseling (control) after 6 months.

Secondary Aims: (2) To determine if greater conversions from IGT to normal glucose tolerance (NGT) and less development of T2DM occurs for those in the BB vs Control Group; (3)To determine if there is improvement in anthropometric/metabolic parameters in BB vs Control Group; and (4) To determine if there is an improvement in psychosocial and family dynamic outcomes of the child in BB vs Control Group.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Center for Clinical Investigation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of IGT (glucose 140-199 at 2 hrs during OGTT)
  • Age 11 to 16
  • An interest in being enrolled in a healthy lifestyle program
  • A parent/caregiver willing to participate with child in program

Exclusion Criteria:

  • Psychiatric disorder or serious medical condition that would preclude participation in program
  • Currently taking medication that potentially effects insulin sensitivity (eg Metformin) or causes weight gain (example: Risperidone) or weight loss (eg Xenical)
  • Involvement in co-existing weight management/healthy lifestyle program
  • Plans of moving out of the Greater New Haven area within six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family-based 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: 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.
Active Comparator: Standard Diet & Activity Education (Control)
Behavioral: Control
Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Lipid profile
Time Frame: 6 months
6 months
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame: 6 months
6 months
Alanine aminotransferase (ALT)
Time Frame: 6 months
6 months
Body mass index (BMI)
Time Frame: 6 months
6 months
Body fat mass and %
Time Frame: 6 months
6 months
Blood pressure (BP)
Time Frame: 6 months
6 months
Piers-Harris Self-concept scale score
Time Frame: 6 months
6 months
Child behavior checklist score
Time Frame: 6 months
6 months
Family assessment device (FAD) score
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institutes of Health (NIH)
National Center for Research Resources (NCRR)

Investigators

  • Principal Investigator: Robert S. Sherwin, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

December 10, 2009

First Submitted That Met QC Criteria

December 11, 2009

First Posted (Estimate)

December 14, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 16, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0908005608
  • 3UL1RR024139-04S2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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