Evaluation of Group Lifestyle Balance DVD in Primary Care Practice (STEP UP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00480779
First received: May 29, 2007
Last updated: June 9, 2011
Last verified: June 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Screening, Training, Education and Prevention Service of the University of Pittsburgh, Phase 2

Resource links provided by NLM:


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 ]

Enrollment: 23
Study Start Date: June 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Group Lifestyle Balance
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Trevor J Orchard, MD University of Pittsburgh
  More Information

Additional Information:
Publications:
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: Dr. Trevor Orchard, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00480779     History of Changes
Other Study ID Numbers: W81XWH-04-2-0030
Study First Received: May 29, 2007
Last Updated: June 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Prediabetes
Metabolic syndrome
Prevention
Lifestyle intervention

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Metabolic Syndrome X
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on August 25, 2014