Evaluation of Group Lifestyle Balance Maintenance Strategies

This study has been completed.
Sponsor:
Collaborator:
Robert C. Atkins Foundation
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00869609
First received: March 24, 2009
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

Heart disease is a leading cause of death in people in the United States. It is a major problem for those with diabetes. Conditions called the metabolic syndrome and pre-diabetes increase risk for diabetes and heart disease. The metabolic syndrome is a group of disorders that occur at the same time. Overall, one in four American adults has the metabolic syndrome. It is more common in people over the age of 40. The metabolic syndrome includes: 1) large waist size, 2) high triglycerides, 3) low HDL cholesterol, 4) high blood pressure and 5) high fasting blood sugar. People with the metabolic syndrome have at least three of these five risk factors. Pre-diabetes is considered to be present in those with high fasting blood sugar levels below the diabetes range.

Research has shown that type 2 diabetes and the metabolic syndrome may be prevented or delayed by making lifestyle changes. It is not known what will most help people continue these healthy changes over time. The purpose of this study is to look at ways to help people continue the healthy lifestyle changes they have made while taking part in a diabetes prevention program called Group Lifestyle Balance (GLB).


Condition Intervention
Diabetes
Behavioral: GLB Traditional Maintenance
Behavioral: GLB-Carb-focused Maintenance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Group Lifestyle Balance Maintenance Strategies

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Efficacy in both groups will be assessed by pre and post-intervention measures of diet (weight loss) and physical activity (the keystones of the intervention). [ Time Frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes to be evaluated include the reduction of global CVD risk, as assessed by the Framingham Score, the presence of metabolic syndrome (NCEP ATP III), and a fall in blood sugar. [ Time Frame: Repeat measures will be obtained at eight months and one year for further evaluation and comparison. ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GLB TM
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
Behavioral: GLB Traditional Maintenance
Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
Active Comparator: GLB-CF
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
Behavioral: GLB-Carb-focused Maintenance
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.

Detailed Description:

Objective: To determine the effectiveness of the Group Lifestyle Balance (GLB) program with an added maintenance component focusing on carbohydrate reduction and hunger management when compared to the GLB program with traditional maintenance.

Research Design and Methods: The original Diabetes Prevention Program intervention was modified from a 16 session individual intervention to a 12 session group-based program called Group Lifestyle Balance (GLB). The Diabetes Prevention Support Center (DPSC) has been created to oversee the implementation of diabetes prevention and CVD risk reduction in various community settings. GLB is a 12-session group based program that focuses on a low fat diet, weight loss and physical activity. This evidence-based intervention is directed at those with pre-diabetes and/or the metabolic syndrome. A monthly maintenance component will be added which provides support in assisting individuals who have completed the 12-session course in the maintenance of healthy lifestyle changes.

The efficacy (in terms of weight reduction) of an added maintenance component focusing on carbohydrate reduction and hunger management will be compared to traditional maintenance. Participants will be randomly assigned to either GLB traditional maintenance (GLB-TM) or GLB and carbohydrate reduced maintenance (GLB-CRM). There will be two groups of approximately 15 subjects in each intervention assignment, for a total of approximately 30 subjects per intervention group and approximately 60 subjects taking part overall. Efficacy in both groups will be assessed by pre and post-intervention measures of diet (weight loss) and physical activity (the keystones of the intervention), as well as the achievement of the two goals: a 7% weight loss by the end of 6 months and 150 minutes of physical activity per week. Secondary outcomes to be evaluated include the reduction of global CVD risk, as assessed by the Framingham Score, the presence of metabolic syndrome (NCEP ATP III), and a fall in blood sugar. Repeat measures will be obtained at six months and one year for further evaluation and comparison.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Non-diabetic patients with metabolic syndrome AND/OR pre-diabetes are eligible for this project based on the following criteria:

  1. Metabolic Syndrome:

    Patients with BMI ≥ 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 ≥130 mmHg (systolic) or ≥85 mmHg (diastolic) OR history of diagnosed hypertension
    • Low HDL level (<40mg/dL men, <50 mg/dL women)
    • Elevated triglyceride level ≥150 mg/dL
    • Fasting glucose ≥100mg/dL and <126mg/dL
  2. Pre-diabetes:

Patients with a BMI ≥25 kg/m2 and pre-diabetes (fasting glucose ≥100 mg/dL and <126mg/dL)

All measures should have been taken within one year of enrollment into the study. A permission for physical activity form must be signed by the participant's physician in order to take part in the study.

Exclusion Criteria:

  • Previous diabetes or diabetes diagnosed as a result of the screening
  • Age <18 years old
  • 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 GILS
  • Any patient who is unable to provide informed consent
  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: NCT00869609

Locations
United States, Pennsylvania
Diabetes Prevention Support Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Robert C. Atkins Foundation
Investigators
Principal Investigator: Trevor J Orchard, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Trevor J. Orchard, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00869609     History of Changes
Other Study ID Numbers: PRO08120047
Study First Received: March 24, 2009
Last Updated: February 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Diabetes Prevention
CVD Risk Reduction
Lifestyle Intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014