Evaluation of Group Lifestyle Balance Maintenance Strategies

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).

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: GLB Traditional Maintenance (TM); Behavioral: GLB-Carb-focused Maintenance (CF)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Diabetes Prevention Support Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GLB Traditional Maintenance (TM); Group Lifestyle Balance (GLB) program Traditional Maintenance: After completion of the GLB 12 core sessions, participants who are randomly assigned to GLB program Traditional Maintenance (TM) 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 (TM); 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. 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-Carb-focused Maintenance (CF); Group Lifestyle Balance (GLB) program Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants randomly assigned to GLB Carb-focused Maintenance (CF) 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 (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 on healthy carbohydrate intake and hunger management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Cholesterol	Total cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in HDL Cholesterol	High-density lipoprotein (HDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in LDL Cholesterol	Low-density lipoprotein (LDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Triglycerides	Triglycerides were measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Fasting Glucose	Fasting plasma glucose was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Glycosylated Hemoglobin A1c (HbA1c)	Collected via venous blood draw, the HbA1c level reflects glucose concentration over the previous period (approximately 8-12 weeks, depending on the individual) and provides an indication of long-term glycemic control.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Systolic Blood Pressure	Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Diastolic Blood Pressure	Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Waist Circumference	Waist circumference was measured at the midpoint between the lower rib margin and the iliac crest; the measurement was repeated twice and the average computed.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Robert C. Atkins Foundation
• Investigators: Principal Investigator: Trevor J Orchard, MD, University of Pittsburgh

Publications and helpful links

Helpful Links

• Diabetes Prevention Support Center of the University of Pittsburgh
• Long-term Strategies for Diabetes Prevention: Evaluation of the Group Lifestyle Balance Post-Core Sessions Focusing on Carbohydrate and Hunger Management

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: March 24, 2009
• First Submitted That Met QC Criteria: March 25, 2009
• First Posted (Estimate): March 26, 2009

Study Record Updates

• Last Update Posted (Estimate): June 24, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Lifestyle Intervention; Diabetes Prevention; CVD Risk Reduction
• Other Study ID Numbers: PRO08120047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No