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Sponsors and Collaborators: |
University of Pittsburgh Department of Defense |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00480779 |
The purpose of this study is to examine different ways of delivering the Group Lifestyle Balance (GLB) intervention (1). The GLB is a 12-week lifestyle change program based on the highly successful lifestyle program that was used in the Diabetes Prevention Program (DPP)(2). A DVD of the Group Lifestyle Program has been developed. Conditions called metabolic syndrome and pre-diabetes increase the risk of diabetes and heart disease. Recent research has shown that type 2 diabetes and metabolic syndrome may be prevented or delayed by making lifestyle changes. Two local primary care practices will be randomly assigned to either the GLB-DVD intervention or usual care. Two additional practices will provide the GLB using trained preventionists for delivery. Approximately 15 patients will be recruited in each practice. It is not known if the GLB intervention works better than what is usually done at the present time for people with metabolic syndrome or pre-diabetes. It is hoped that this research study will provide information to help answer that question.
Condition | Intervention |
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Prediabetes Metabolic Syndrome |
Behavioral: Group Lifestyle Balance |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Screening, Training, Education and Prevention Service of the University of Pittsburgh, Phase 2 |
Estimated Enrollment: | 60 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Non-diabetic patients with metabolic syndrome AND/OR pre-diabetes are eligible for the study with referral from their physician based on the following criteria:
Metabolic Syndrome: Patients with BMI greater than or equal to 25 kg/m2, with at least 3 of the following risk factors for metabolic syndrome:
Exclusion Criteria:
Those patients age less than 18 years old will not be invited to be part of the study. In addition, patients with any of the following conditions are not eligible to take part in the study:
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Trevor J Orchard, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Dr. Trevor Orchard ) |
Study ID Numbers: | W81XWH-04-2-0030 |
Study First Received: | May 29, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00480779 History of Changes |
Health Authority: | United States: Institutional Review Board |
Prediabetes Metabolic syndrome Prevention Lifestyle intervention |
Metabolic Diseases Hyperglycemia Glucose Intolerance Diabetes Mellitus Prediabetic State |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Hyperglycemia Pathologic Processes Disease Syndrome |
Glucose Intolerance Diabetes Mellitus Prediabetic State Endocrine System Diseases Glucose Metabolism Disorders |