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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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.
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.
Diabetes Prevention Support Center
Pittsburgh, Pennsylvania, United States
Change in Weight
Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
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