Evaluation of Group Lifestyle Balance Maintenance Strategies

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Evaluation of Group Lifestyle Balance Maintenance Strategies

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: GLB Traditional Maintenance (TM)
* Behavioral: GLB-Carb-focused Maintenance (CF)


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GLB Traditional Maintenance (TM)<br>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)<br>* 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.<br>|
| Active Comparator: GLB-Carb-focused Maintenance (CF)<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Prevention, CVD Risk Reduction, Lifestyle Intervention