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

This study has been completed.
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Trevor J. Orchard, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00480779
First received: May 29, 2007
Last updated: May 19, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Prediabetes
Metabolic Syndrome
Behavioral: GLB Group
Behavioral: GLB DVD

Study Type: Interventional
Study Design: Allocation: Non-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:
  • Change in Weight [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    The primary outcome for this study will be change in weight measured pre and post intervention.


Secondary Outcome Measures:
  • Change in Waist Circumference [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    A secondary outcome for this study will be change in waist circumference, measured pre and post intervention.

  • Change in Total Cholesterol [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    A secondary outcome for this study will be change in total cholesterol, measured pre and post intervention.

  • Change in HDL Cholesterol [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    A secondary outcome for this study will be change in HDL cholesterol, measured pre and post intervention.

  • Change in LDL Cholesterol [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    A secondary outcome for this study will be change in LDL cholesterol, measured pre and post intervention.

  • Change in Fasting Glucose [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    A secondary outcome for this study will be change in fasting glucose, measured pre and post intervention.

  • Change in Hemoglobin A1C [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    A secondary outcome for this study will be change in HbA1c, measured pre and post intervention. The hemoglobin HbA1c test provides information regarding how well blood glucose (sugar) has been controlled for the previous 8-12 weeks..

  • Change in Systolic Blood Pressure [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    A secondary outcome for this study will be change in systolic blood pressure, measured pre and post intervention.

  • Change in Diastolic Blood Pressure [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    A secondary outcome for this study will be change in diastolic blood pressure, measured pre and post intervention.

  • Change in Triglycerides [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    A secondary outcome for this study will be change in Triglyceride level, measured pre and post intervention.


Enrollment: 48
Study Start Date: June 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GLB Group
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. 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.
Behavioral: GLB Group
The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
GLB DVD
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. 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.
Behavioral: GLB DVD
The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and weekly telephone contact with a trained lifestyle coach.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
United States Department of Defense
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: Trevor J. Orchard, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00480779     History of Changes
Other Study ID Numbers: W81XWH-04-2-0030 
Study First Received: May 29, 2007
Results First Received: January 11, 2016
Last Updated: May 19, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on September 30, 2016