- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409889
Comparing Diabetes Prevention Programs
January 15, 2016 updated by: Nancy Bennett, University of Rochester
Comparative Effectiveness of Practice-Based Diabetes Prevention Programs - A Pilot Study
The purpose of this study is to compare the effectiveness and costs of two programs,the Diabetes Prevention Program and the community-developed Healthy Living Program, delivered in an primary care practice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14605
- Anthony Jordan Health Center
-
Rochester, New York, United States, 14605
- Rochester General Medical Associates
-
Rochester, New York, United States, 14606
- Unity Health System
-
Rochester, New York, United States, 14611
- Westside Health Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- at least 18 years old
- diagnosed with pre-diabetes
Exclusion Criteria:
- diagnosed with diabetes
- pregnant or nursing
- unable to walk 2-3 blocks in 10 minutes
- unable to read and speak English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Diabetes Prevetion Program
Individuals in this group will receive the Diabetes Prevention Program
|
Other Names:
|
|
Active Comparator: Healthy Living Program
Individuals in this group will receive the Healthy Living Program
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Weight
Time Frame: 22 weeks
|
7% reduction in participant weight
|
22 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minutes of Physical Activity
Time Frame: 22 weeks
|
Increase physical activity to 150 minutes per week.
|
22 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 2, 2011
First Submitted That Met QC Criteria
August 2, 2011
First Posted (Estimate)
August 4, 2011
Study Record Updates
Last Update Posted (Estimate)
January 18, 2016
Last Update Submitted That Met QC Criteria
January 15, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTSI 5-27805
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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