Evaluation of Group Lifestyle Balance DVD in Primary Care Practice

Completed · Not applicable

Conditions studied: Prediabetes, Metabolic Syndrome

In brief

The purpose of this study is to examine different methods 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. A primary care practice will enroll participants who will choose either the GLB-DVD intervention or face-to-face group delivery. Approximately 25 patients will be recruited in each group. It is not known if the GLB intervention delivered via DVD is similarly effective to face-to-face group delivery for people with metabolic syndrome or pre-diabetes. It is hoped that this research study will provide information to help answer that question.

Key facts

Study ID

NCT00480779

Run by

University of Pittsburgh

People needed

48

Starts

2007-06-01

Expected to finish

2009-05-01

Last updated by the study team

2016-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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