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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Dietitian Counseling Alone | Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian |
| BEHAVIORAL | Dietitian Plus Community Group Lifestyle | Primary 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.