Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Chicago, Illinois 60611


Purpose:

The purpose of this study is to determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of type 2 diabetes.


Study summary:

Randomized controlled trials have shown that modest lifestyle changes can prevent or delay the onset of diabetes in adults with pre-diabetes. Unfortunately, despite the increasing prevalence of pre-diabetes and diabetes in all facets of the population, intervention programs needed to achieve these goals are costly and remain unavailable in most clinical settings. Over the past 3 years, we have demonstrated the feasibility of training community instructors to deliver a group-based adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention. In this pilot research, this new delivery model achieves a level of weight reduction that was associated with diabetes prevention and improved cardiometabolic risk factor control in the DPP. This new, large-scale randomized effectiveness trial is designed to evaluate the costs and effectiveness of a partnered approach to identify adults with pre-diabetes in primary care settings, deliver brief advice for diabetes prevention, and provide access to a group-based adaptation of the DPP lifestyle intervention offered by the community. This study will compare costs and outcomes to a standard care, brief clinical counseling approach delivered by Registered Dietitians.


Criteria:

Inclusion Criteria: - 18 years of age or older - Body-mass index of 24 kg/m2 or greater - Fasting Blood Glucose 100 - 125 mg/dl, OR 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl Exclusion Criteria: - Cancer requiring treatment in the past 5 years - Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg - Heart attack, stroke, or transient ischemic attack in the past 6 months, - Chronic obstructive airways disease or asthma requiring home oxygen - Other chronic disease or condition, such as advanced arthritis, that could limit ability to become physically active or limit life span to <5 years - Pregnancy - Existing diagnosis of diabetes mellitus - Fasting capillary blood glucose > 125 mg/dl - 2-hour post-challenge capillary blood glucose > 199 mg/dl - History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes - Self-report of a medication known to lead to hyperglycemia (oral steroids, antipsychotics, anti-epileptics) - Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis


NCT ID:

NCT00656682


Primary Contact:

Principal Investigator
Ronald T Ackermann, MD, MPH
Northwestern University School of Medicine


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.