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

Not Applicable

Completed

• Conditions: Impaired Glucose Tolerance
• Interventions: Behavioral: Bright Bodies Healthy Lifestyle Program; Behavioral: Control

• Registration Number: NCT01030978
• Lead Sponsor: Yale University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-11
• Study First Posted: 2009-12-14
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-16
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family-based Healthy Lifestyle Program	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.
Standard Diet & Activity Education (Control)	Control	-

Primary Outcome Measures

Name	Time	Method
2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM)	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yale Center for Clinical Investigation; 🇺🇸 New Haven, Connecticut, United States