NCT01030978

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

December 10, 2009

Last Update Submit

June 16, 2014

Conditions

Impaired Glucose Tolerance

Keywords

Impaired Glucose TolerancePreDiabetesDiabetes Prevention

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (9)

  • Homeostasis model assessment of insulin resistance (HOMA-IR)

    6 months

  • Lipid profile

    6 months

  • Alanine aminotransferase (ALT)

    6 months

  • Body mass index (BMI)

    6 months

  • Body fat mass and %

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Family-based Healthy Lifestyle Program

EXPERIMENTAL

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.

Behavioral: Bright Bodies Healthy Lifestyle Program

Standard Diet & Activity Education (Control)

ACTIVE COMPARATOR
Behavioral: Control

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.

Family-based Healthy Lifestyle Program
ControlBEHAVIORAL

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

Standard Diet & Activity Education (Control)

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Clinical Investigation

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • Taylor JH, Xu Y, Li F, Shaw M, Dziura J, Caprio S, Tamborlane WV, Nowicka P, Savoye M. Psychosocial predictors and moderators of weight management programme outcomes in ethnically diverse obese youth. Pediatr Obes. 2017 Dec;12(6):453-461. doi: 10.1111/ijpo.12165. Epub 2016 Jul 7.

    PMID: 27384496DERIVED

MeSH Terms

Conditions

Glucose IntolerancePrediabetic State

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Robert S. Sherwin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2009

First Posted

December 14, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

US(1)