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NCT01409889 Clinical Trial

Comparing Diabetes Prevention Programs

Diabetes Clinical Trial

Official title:
Comparative Effectiveness of Practice-Based Diabetes Prevention Programs - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01409889
Other study ID # CTSI 5-27805
Secondary ID
Status Completed
Phase N/A
First received August 2, 2011
Last updated January 15, 2016
Start date May 2011
Est. completion date August 2012

Study information
Verified date January 2016
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Diabetes Prevention Program

• Healthy Living Program

Locations
Country Name City State
United States Anthony Jordan Health Center Rochester New York
United States Rochester General Medical Associates Rochester New York
United States Unity Health System Rochester New York
United States Westside Health Services Rochester New York

Sponsors (1)
Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Participant Weight 7% reduction in participant weight 22 weeks No
Secondary Minutes of Physical Activity Increase physical activity to 150 minutes per week. 22 weeks No
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