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

Impaired Glucose Tolerance Clinical Trial

Official title:

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

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

• Glucose Intolerance
• Impaired Glucose Tolerance

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