Impaired Glucose Tolerance Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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