NCT01030978

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 11 Years – 16 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Impaired Glucose Tolerance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2009-12-14
• Last updated: 2014-06-17

Locations

1 site across 1 country: United States