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

Primary Purpose

Impaired Glucose Tolerance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright Bodies Healthy Lifestyle Program
Control
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Impaired Glucose Tolerance focused on measuring Impaired Glucose Tolerance, PreDiabetes, Diabetes Prevention

Eligibility Criteria

11 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Yale Center for Clinical Investigation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family-based Healthy Lifestyle Program

Standard Diet & Activity Education (Control)

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Homeostasis model assessment of insulin resistance (HOMA-IR)
Lipid profile
Alanine aminotransferase (ALT)
Body mass index (BMI)
Body fat mass and %
Blood pressure (BP)
Piers-Harris Self-concept scale score
Child behavior checklist score
Family assessment device (FAD) score

Full Information

First Posted
December 10, 2009
Last Updated
June 16, 2014
Sponsor
Yale University
Collaborators
National Institutes of Health (NIH), National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT01030978
Brief Title
Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
Official Title
Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institutes of Health (NIH), National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
Keywords
Impaired Glucose Tolerance, PreDiabetes, Diabetes Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family-based Healthy Lifestyle Program
Arm Type
Experimental
Arm 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.
Arm Title
Standard Diet & Activity Education (Control)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Bright Bodies Healthy Lifestyle Program
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months.
Primary Outcome Measure Information:
Title
2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame
6 months
Title
Lipid profile
Time Frame
6 months
Title
Alanine aminotransferase (ALT)
Time Frame
6 months
Title
Body mass index (BMI)
Time Frame
6 months
Title
Body fat mass and %
Time Frame
6 months
Title
Blood pressure (BP)
Time Frame
6 months
Title
Piers-Harris Self-concept scale score
Time Frame
6 months
Title
Child behavior checklist score
Time Frame
6 months
Title
Family assessment device (FAD) score
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S. Sherwin, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Center for Clinical Investigation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27384496
Citation
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.
Results Reference
derived

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

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