Evaluation of Group Lifestyle Balance Maintenance Strategies

Diabetes Clinical Trial

Official title:

Evaluation of Group Lifestyle Balance Maintenance Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869609
• Other study ID #: PRO08120047
• Status: Completed
• Phase: N/A
• First received: March 24, 2009
• Last updated: January 11, 2016
• Start date: March 2009
• Est. completion date: August 2010

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Diabetes Prevention Support Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Robert C. Atkins Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Total Cholesterol	Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides and fasting plasma glucose 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	No
Secondary	Change in HDL Cholesterol	Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides and fasting plasma glucose 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	No
Secondary	Change in LDL Cholesterol	Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides and fasting plasma glucose 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	No
Secondary	Change in Triglycerides	Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides and fasting plasma glucose 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	No
Secondary	Change in Fasting Glucose	Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides and fasting plasma glucose 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	No
Secondary	Change in HbA1c	Collected via venous blood draw.	Measured at 8 months post intervention and 4 months post-randomization to maintenance group	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Diabetes Prevention Support Center of the University of Pittsburgh