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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01030978
First received: December 10, 2009
Last updated: June 16, 2014
Last verified: June 2014

December 10, 2009
June 16, 2014
September 2009
August 2011   (final data collection date for primary outcome measure)
2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01030978 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Impaired Glucose Tolerance
  • 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.
  • 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.
    Intervention: Behavioral: Bright Bodies Healthy Lifestyle Program
  • Active Comparator: Standard Diet & Activity Education (Control)
    Intervention: Behavioral: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
September 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
11 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01030978
0908005608, 3UL1RR024139-04S2
No
Yale University
Yale University
  • National Institutes of Health (NIH)
  • National Center for Research Resources (NCRR)
Principal Investigator: Robert S. Sherwin, MD Yale University
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP