Clinical Trials Directory

Trials / Completed

CompletedNCT00656682

Primary Care Community Partnerships to Prevent Diabetes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
509 (actual)
Sponsor
Northwestern University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDietitian Counseling AlonePrimary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
BEHAVIORALDietitian Plus Community Group LifestylePrimary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based lifestyle intervention offered by the Community to prevent diabetes

Timeline

Start date
2008-04-01
Primary completion
2013-08-01
Completion
2013-08-01
First posted
2008-04-11
Last updated
2018-03-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00656682. Inclusion in this directory is not an endorsement.