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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01030978
First received: December 10, 2009
Last updated: December 11, 2009
Last verified: December 2009
History of Changes
  Purpose

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).


Condition Intervention
Impaired Glucose Tolerance
 Behavioral: Bright Bodies Healthy Lifestyle Program
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Alanine aminotransferase (ALT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body mass index (BMI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body fat mass and % [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood pressure (BP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Piers-Harris Self-concept scale score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Child behavior checklist score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Family assessment device (FAD) score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030978

Contacts
Contact: Mary Savoye, RD 203-737-4384 mary.savoye@yale.edu

Locations
United States, Connecticut
Yale Center for Clinical Investigation Recruiting
New Haven, Connecticut, United States, 06520
Contact: Mary Savoye, RD     203-737-4384     mary.savoye@yale.edu    
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Robert S. Sherwin, MD Yale University
  More Information

No publications provided

Responsible Party: Robert Sherwin, MD, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01030978     History of Changes
Other Study ID Numbers: 0908005608, 3UL1RR024139-04S2
Study First Received: December 10, 2009
Last Updated: December 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Impaired Glucose Tolerance
PreDiabetes
Diabetes Prevention

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on May 22, 2013