Evaluation of Group Lifestyle Balance DVD in Primary Care Practice - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Department of Defense
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00480779

Purpose

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
Prediabetes Metabolic Syndrome	Behavioral: Group Lifestyle Balance

MedlinePlus related topics: Diabetes

U.S. FDA Resources

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

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

The primary outcome for this study will be changes in weight measured pre and post intervention, as well as at the 6 and 12 month assessments. [ Time Frame: Baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Key secondary outcomes for this study will include changes in glucose as well as global CVD risk. Quality of life and quality of well-being will also be assessed. [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]

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)

Intervention Details:

The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

All non-diabetic patients age 18 years and older at the time of enrollment considered to be patients of the practices that are taking part in this project will be eligible for the study upon referral from their physician.
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:
  - Waist circumference (>40 inches men, >35 inches women)
  - Blood pressure greater than or equal to 130 mmHg (systolic) and/or 85 mmHg (diastolic) OR history of diagnosed hypertension
  - Low HDL level (<40mg/dL men, <50 mg/dL women)
  - Elevated triglyceride level greater than or equal to 150 mg/dL
  - Fasting glucose greater than or equal to 100mg/dL and <126mg/dL
- Pre-diabetes: Patients with a BMI greater than or equal to 25 kg/m2 and pre-diabetes (fasting glucose greater than or equal to 100 mg/dL and <126mg/dL)
All measures should have been taken within six months of enrollment into the study. The physician in each center will be asked to refer eligible patients to the study. It will be the responsibility of the referring physician to determine eligibility and appropriateness of the patient's participation.

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:
- Those with previous diabetes diagnosis
- Women who are currently (or within past 6-weeks) pregnant or lactating
- Any patient deemed by their physician not to be a candidate
- Any patient planning to leave the area before the end of the program
- Individuals that are not patients of the participating primary care practices

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480779

Locations

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Department of Defense

Investigators

Principal Investigator:

Trevor J Orchard, MD

University of Pittsburgh

More Information

Additional Information:

Diabetes Prevention Support Center of the University of Pittsburgh Diabetes Institute This link exits the ClinicalTrials.gov site

Publications:

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403.

Kramer, MK, Miller, R, Venditti, E, Orchard, TO. Group Lifestyle Intervention for Diabetes Prevention in Those with Metabolic Syndrome in Primary Care Practice. Diabetes. June, 2006. 55: Supp., A517.

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

Keywords provided by University of Pittsburgh:

Prediabetes
Metabolic syndrome
Prevention
Lifestyle intervention

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Glucose Intolerance
Diabetes Mellitus
Prediabetic State

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Hyperglycemia
Pathologic Processes
Disease
Syndrome

Glucose Intolerance
Diabetes Mellitus
Prediabetic State
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009