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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01030978
Other study ID # 0908005608
Secondary ID 3UL1RR024139-04S
Status Completed
Phase N/A
First received December 10, 2009
Last updated June 16, 2014
Start date September 2009
Est. completion date September 2011

Study information

Verified date June 2014
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date September 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 11 Years to 16 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.
Control
Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months.

Locations

Country Name City State
United States Yale Center for Clinical Investigation New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Yale University National Center for Research Resources (NCRR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM) 6 months No
Secondary Homeostasis model assessment of insulin resistance (HOMA-IR) 6 months No
Secondary Lipid profile 6 months No
Secondary Alanine aminotransferase (ALT) 6 months No
Secondary Body mass index (BMI) 6 months No
Secondary Body fat mass and % 6 months No
Secondary Blood pressure (BP) 6 months No
Secondary Piers-Harris Self-concept scale score 6 months No
Secondary Child behavior checklist score 6 months No
Secondary Family assessment device (FAD) score 6 months No
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