An interventional study of GLB Traditional Maintenance (TM) and GLB-Carb-focused Maintenance (CF) in Diabetes, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-24.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Prevention
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.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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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:
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:
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)
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. 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.
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
The project was implemented in two settings: the first within an urban University campus and the second at a suburban YMCA. Recruitment commenced in May 2009 and was completed in July 2009.
| Milestone | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Started | 31 | 29 |
| Completed | 25 | 26 |
| Not completed | 6 | 3 |
Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.
| pounds | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Change in Weight | 2.1 ± 5.9 | 0.2 ± 7.1 |
Total cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
| mg/dl | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Change in Total Cholesterol | 8.6 ± 23.2 | 15.4 ± 23.7 |
High-density lipoprotein (HDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
| mg/dl | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Change in HDL Cholesterol | 2.9 ± 7.0 | 5.1 ± 6.4 |
Low-density lipoprotein (LDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
| mg/dl | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Change in LDL Cholesterol | 5.2 ± 20.0 | 5.8 ± 23.3 |
Triglycerides were measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
| mg/dl | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Change in Triglycerides | -0.003 ± 0.22 | -0.006 ± 39 |
Fasting plasma glucose was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
| mg/dl | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Change in Fasting Glucose | 1.2 ± 4.7 | 0.2 ± 6.9 |
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.
| percentage of glycosylated hemoglobin | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Change in Glycosylated Hemoglobin A1c (HbA1c) | -0.06 ± 0.18 | -0.08 ± .18 |
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.
| mmHg | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Change in Systolic Blood Pressure | -0.43 ± 10.5 | -3.6 ± 10.8 |
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.
| mmHg | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Change in Diastolic Blood Pressure | -2.1 ± 7.0 | -3.2 ± 8.8 |
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.
| inches | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) |
|---|---|---|
| Change in Waist Circumference | -0.4 ± 1.3 | -0.2 ± 1.4 |
Collected over Approximately 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GLB Traditional Maintenance (TM) | — | 0/31 (0%) | 0/31 (0%) |
| GLB-Carb-focused Maintenance (CF) | — | 0/29 (0%) | 0/29 (0%) |
| Age, Continuous(years) | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) | Total |
|---|---|---|---|
| Mean | 55.9 ± 9.4 | 53.4 ± 11.6 | 54.7 ± 10.5 |
| Sex: Female, Male(Participants) | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) | Total |
|---|---|---|---|
| Female | 20 | 19 | 39 |
| Male | 11 | 10 | 21 |
| Region of Enrollment(participants) | GLB Traditional Maintenance (TM) | GLB-Carb-focused Maintenance (CF) | Total |
|---|---|---|---|
| United States | 31 | 29 | 60 |
Plan to share: No
The record gives a start of Mar 2009, a primary completion of Aug 2010 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2016, 5 years 6 months after primary completion.
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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