Evaluation of Group Lifestyle Balance DVD in Primary Care Practice

Metabolic Syndrome Clinical Trial

— STEP UP  

Official title:

Screening, Training, Education and Prevention Service of the University of Pittsburgh, Phase 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480779
• Other study ID #: W81XWH-04-2-0030
• Status: Completed
• Phase: N/A
• First received: May 29, 2007
• Last updated: June 9, 2011
• Start date: June 2007
• Est. completion date: May 2009

Study information

• Verified date: June 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Metabolic Syndrome
• Metabolic Syndrome X
• Prediabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Baseline, 3, 6, and 12 months	No
Secondary	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.		Baseline, 3, 6 and 12 months	No

External Links

•   Diabetes Prevention Support Center of the University of Pittsburgh