Clinical trial NCT01030978: 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
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Keywords: Impaired Glucose Tolerance
PreDiabetes
Diabetes Prevention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Research Resources (NCRR)
First posted: 2009-12-14
Enrollment: 72
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM)
timeFrame: 6 months
Secondary outcomes:
measure: Homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: 6 months
measure: Lipid profile
timeFrame: 6 months
measure: Alanine aminotransferase (ALT)
timeFrame: 6 months
measure: Body mass index (BMI)
timeFrame: 6 months
measure: Body fat mass and %
timeFrame: 6 months
measure: Blood pressure (BP)
timeFrame: 6 months
measure: Piers-Harris Self-concept scale score
timeFrame: 6 months
measure: Child behavior checklist score
timeFrame: 6 months
measure: Family assessment device (FAD) score
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
Study officials:
affiliation: Yale University
name: Robert S. Sherwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.