Clinical trial NCT00480779: Evaluation of Group Lifestyle Balance DVD in Primary Care Practice
Official title: Screening, Training, Education and Prevention Service of the University of Pittsburgh, Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Metabolic Syndrome
Keywords: Prediabetes
Metabolic syndrome
Prevention
Lifestyle intervention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2007-05-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The Group Lifestyle Balance program is a 12-session lifestyle intervention with the same goals for weight loss and physical activity as the successful Diabetes Prevention Program (DPP) lifestyle intervention and has been evaluated in several settings. The DPSC collaborated with the US Air Force Center of Excellence for Medical Multimedia to create a DVD of the GLB. The GLB-DVD is a series of taped sessions of a staged group following a script that was developed to closely follow the program.

Effectiveness was assessed for the intervention delivered via DVD (GLB-DVD) as well as traditionally in a group setting (GLB-GROUP). For each delivery mode, pre- and 3 month post-intervention measures of weight and the achievement of the program goals were assessed. Secondary outcomes measured included assessment of components of the metabolic syndrome (NCEP ATP III) and HbA1c.

The prevention professionals in the practice and the Diabetes Prevention Support Center (DPSC) who provided support for the GLB-DVD and GLB-GROUP participants were health care professionals trained in delivery of the GLB by the DPSC faculty. Group delivery of the GLB was conducted via weekly in person, meetings delivered over 12-15 weeks. For GLB-DVD delivery, an overview of the GLB-DVD and materials was provided at commencement of the intervention. Participants were instructed to view one session/week. At the end of each month the participant was asked to return their DVD via postage-paid mail to the DPSC and the next sequential DVD was mailed to the participant. During GLB-DVD delivery, the DPSC prevention professional contacted the participant weekly via telephone to review weight, physical activity minutes, and questions/concerns regarding the program. Thus, participants in both GLB-GROUP and GLB-DVD were offered a total of 12 health care professional contacts. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.

Eligibility 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

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: Baseline and 3 months
measure: Change in Total Cholesterol
timeFrame: Baseline and 3 months
measure: Change in HDL Cholesterol
timeFrame: Baseline and 3 months
measure: Change in LDL Cholesterol
timeFrame: Baseline and 3 months
measure: Change in Fasting Glucose
timeFrame: Baseline and 3 months
measure: Change in Hemoglobin A1C
timeFrame: Baseline and 3 months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 3 months
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline and 3 months
measure: Change in Triglycerides
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Trevor J Orchard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1056/NEJMoa012512.
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.