N/A N=60 Randomized Prevention

Evaluation of Group Lifestyle Balance Maintenance Strategies

Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT00869609 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Change in Weight — 2.1; 0.2 pounds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: GLB Traditional Maintenance (TM) (Behavioral); GLB-Carb-focused Maintenance (CF) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Weight	2.1; 0.2	—
SECONDARY Change in Total Cholesterol	8.6; 15.4	—
SECONDARY Change in HDL Cholesterol	2.9; 5.1	—
SECONDARY Change in LDL Cholesterol	5.2; 5.8	—
SECONDARY Change in Triglycerides	-0.003; -0.006	—
SECONDARY Change in Fasting Glucose	1.2; 0.2	—
SECONDARY Change in Glycosylated Hemoglobin A1c (HbA1c)	-0.06; -0.08	—
SECONDARY Change in Systolic Blood Pressure	-0.43; -3.6	—
SECONDARY Change in Diastolic Blood Pressure	-2.1; -3.2	—
SECONDARY Change in Waist Circumference	-0.4; -0.2	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00869609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.