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Completed

NCT Number: NCT01030978

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

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).

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Key information

Conditions

Impaired Glucose Tolerance Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Center for Clinical Investigation

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bright Bodies Healthy Lifestyle Program

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.

Control

Behavioral

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

Primary outcomes

  1. 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM)

    Time frame: 6 months

Secondary outcomes

  1. Homeostasis model assessment of insulin resistance (HOMA-IR)

    Time frame: 6 months

  2. Lipid profile

    Time frame: 6 months

  3. Alanine aminotransferase (ALT)

    Time frame: 6 months

  4. Body mass index (BMI)

    Time frame: 6 months

  5. Body fat mass and %

    Time frame: 6 months

  6. Blood pressure (BP)

    Time frame: 6 months

  7. Piers-Harris Self-concept scale score

    Time frame: 6 months

  8. Child behavior checklist score

    Time frame: 6 months

  9. Family assessment device (FAD) score

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 14, 2009
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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