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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Impaired Glucose Tolerance

Intervention / Treatment
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* Behavioral: Bright Bodies Healthy Lifestyle Program
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family-based Healthy Lifestyle Program<br>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<br>* 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.<br>|
| Active Comparator: Standard Diet & Activity Education (Control)<br> | Behavioral: Control<br>* Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM) |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impaired Glucose Tolerance, PreDiabetes, Diabetes Prevention