Evaluation of Group Lifestyle Balance Maintenance Strategies

NCT00869609 | Completed Results

• 1 other identifier: PRO08120047
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetes

Keywords

Diabetes Prevention; CVD Risk Reduction; Lifestyle Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Total Cholesterol

  Measured at 8 months post intervention and 4 months post-randomization to maintenance group

• Change in HDL Cholesterol

  Measured at 8 months post intervention and 4 months post-randomization to maintenance group

• Change in LDL Cholesterol

  Measured at 8 months post intervention and 4 months post-randomization to maintenance group

• Change in Triglycerides

  Measured at 8 months post intervention and 4 months post-randomization to maintenance group

• Change in Fasting Glucose

  Measured at 8 months post intervention and 4 months post-randomization to maintenance group

Study Arms (2)

GLB Traditional Maintenance (TM)

ACTIVE COMPARATOR

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)

GLB-Carb-focused Maintenance (CF)

ACTIVE COMPARATOR

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)

Interventions

GLB Traditional Maintenance (TM) BEHAVIORAL

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.

GLB Traditional Maintenance (TM)

GLB-Carb-focused Maintenance (CF) BEHAVIORAL

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.

GLB-Carb-focused Maintenance (CF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Robert C. Atkins Foundation: collaborator

Study Sites (1)

Diabetes Prevention Support Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related 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

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The sample size was small and included primarily white individuals, so these results may not be generalizable to other groups. The CPC was not carbohydrate restricted and may not be directly comparable to studies that focus on carbohydrate reduction.

Results Point of Contact

• Title: Trevor J Orchard
• Organization: University of Pittsburgh

tjo@pitt.edu

412-383-1032

Study Officials

• Trevor J Orchard, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 26, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 24, 2016
• Results First Posted: February 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)