NCT00480779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

June 28, 2016

Completed
Last Updated

June 28, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

May 29, 2007

Results QC Date

January 11, 2016

Last Update Submit

May 19, 2016

Conditions

PrediabetesMetabolic Syndrome

Keywords

PrediabetesMetabolic syndromePreventionLifestyle intervention

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    The primary outcome for this study will be change in weight measured pre and post intervention.

    Baseline and 3 months

Secondary Outcomes (9)

  • Change in Waist Circumference

    Baseline and 3 months

  • Change in Total Cholesterol

    Baseline and 3 months

  • Change in HDL Cholesterol

    Baseline and 3 months

  • Change in LDL Cholesterol

    Baseline and 3 months

  • Change in Fasting Glucose

    Baseline and 3 months

  • +4 more secondary outcomes

Study Arms (2)

GLB Group

OTHER

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

GLB DVD

OTHER

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

Interventions

GLB GroupBEHAVIORAL

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 Group
GLB DVDBEHAVIORAL

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.

GLB DVD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related 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. doi: 10.1056/NEJMoa012512.

    PMID: 11832527BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Prediabetic StateMetabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Limitations and Caveats

It should be noted that this was a small pilot study and should be tested in a larger sample.

Results Point of Contact

Title
M. Kaye Kramer
Organization
University of Pittsburgh
mkk3@pitt.edu
4123831286

Study Officials

  • Trevor J Orchard, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 31, 2007

Study Start

June 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 28, 2016

Results First Posted

June 28, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)