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

Yale University72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Impaired Glucose Tolerance

Interventions

Bright Bodies Healthy Lifestyle ProgramBEHAVIORAL

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.

ControlBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 11 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale Center for Clinical Investigation

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM)

Time frame: 6 months

Secondary Outcomes

Homeostasis model assessment of insulin resistance (HOMA-IR)

Time frame: 6 months

Lipid profile

Time frame: 6 months

Alanine aminotransferase (ALT)

Time frame: 6 months

Body mass index (BMI)

Time frame: 6 months

Body fat mass and %

Time frame: 6 months

Blood pressure (BP)

Time frame: 6 months

Piers-Harris Self-concept scale score

Time frame: 6 months

Child behavior checklist score

Time frame: 6 months

Family assessment device (FAD) score

Time frame: 6 months

Data from ClinicalTrials.gov

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