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| ID | Type | Description | Link |
|---|---|---|---|
| 3UL1RR024139-04S2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family-based Healthy Lifestyle Program | Experimental | 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. |
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| Standard Diet & Activity Education (Control) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright Bodies Healthy Lifestyle Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Homeostasis model assessment of insulin resistance (HOMA-IR) | 6 months | |
| Lipid profile | 6 months | |
| Alanine aminotransferase (ALT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S. Sherwin, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Center for Clinical Investigation | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27384496 | Derived | Taylor JH, Xu Y, Li F, Shaw M, Dziura J, Caprio S, Tamborlane WV, Nowicka P, Savoye M. Psychosocial predictors and moderators of weight management programme outcomes in ethnically diverse obese youth. Pediatr Obes. 2017 Dec;12(6):453-461. doi: 10.1111/ijpo.12165. Epub 2016 Jul 7. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Control | Behavioral | Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months. |
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| 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 |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |