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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01030978
First received: December 10, 2009
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention
Impaired Glucose Tolerance
Behavioral: Bright Bodies Healthy Lifestyle Program
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Alanine aminotransferase (ALT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body mass index (BMI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body fat mass and % [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood pressure (BP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Piers-Harris Self-concept scale score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Child behavior checklist score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Family assessment device (FAD) score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: Standard Diet & Activity Education (Control) Behavioral: Control
Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months.

Detailed 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.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030978

Locations
United States, Connecticut
Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Robert S. Sherwin, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01030978     History of Changes
Other Study ID Numbers: 0908005608, 3UL1RR024139-04S2
Study First Received: December 10, 2009
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Impaired Glucose Tolerance
PreDiabetes
Diabetes Prevention

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Glucose Intolerance
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014