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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth

NCT01610219

Diabetes Mellitus, Type 2 Obesity

COMPLETED NA

Obesity and Diabetes Prevention Through Science Enrichment

NCT00541879

Type 2 Diabetes Obesity

COMPLETED NA

In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes

NCT06557317

Behavior, Adolescent Childhood Obesity Diabetes Mellitus, Type 2 +9 more

RECRUITING NA

Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

NCT05695170

PreDiabetes Prediabetic State Overweight and Obesity

COMPLETED NA

Diabetes Prevention Program

NCT00004992

Diabetes Mellitus, Non-Insulin-Dependent Glucose Intolerance

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Impaired Glucose Tolerance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Family-based 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.

Group Type EXPERIMENTAL

Bright Bodies Healthy Lifestyle Program

Intervention Type BEHAVIORAL

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.

Standard Diet & Activity Education (Control)

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No