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

Yale University

Status: Completed

Conditions: Impaired Glucose Tolerance

Treatments: Behavioral: Control; Behavioral: Bright Bodies Healthy Lifestyle Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01030978

3UL1RR024139-04S2 (U.S. NIH Grant/Contract)

0908005608

Details and patient eligibility

About

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).

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 11 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Family-based Healthy Lifestyle Program

Experimental group

Description:

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.

Treatment:

Behavioral: Bright Bodies Healthy Lifestyle Program

Standard Diet & Activity Education (Control)

Active Comparator group

Treatment:

Behavioral: Control