Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 11 - 16 |
| Updated: | 5/5/2014 |
| Start Date: | September 2009 |
| End Date: | September 2011 |
| Contact: | Mary Savoye, RD |
| Email: | mary.savoye@yale.edu |
| Phone: | 203-737-4384 |
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).
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.
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.
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
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