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Comparing Diabetes Prevention Programs

Primary Purpose

Pre Diabetes, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Prevention Program
Healthy Living Program
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anthony Jordan Health Center
  • Rochester General Medical Associates
  • Unity Health System
  • Westside Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Diabetes Prevetion Program

Healthy Living Program

Arm Description

Individuals in this group will receive the Diabetes Prevention Program

Individuals in this group will receive the Healthy Living Program

Outcomes

Primary Outcome Measures

Participant Weight
7% reduction in participant weight

Secondary Outcome Measures

Minutes of Physical Activity
Increase physical activity to 150 minutes per week.

Full Information

First Posted
August 2, 2011
Last Updated
January 15, 2016
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT01409889
Brief Title
Comparing Diabetes Prevention Programs
Official Title
Comparative Effectiveness of Practice-Based Diabetes Prevention Programs - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes, Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Prevetion Program
Arm Type
Active Comparator
Arm Description
Individuals in this group will receive the Diabetes Prevention Program
Arm Title
Healthy Living Program
Arm Type
Active Comparator
Arm Description
Individuals in this group will receive the Healthy Living Program
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program
Other Intervention Name(s)
DPP
Intervention Type
Behavioral
Intervention Name(s)
Healthy Living Program
Other Intervention Name(s)
HLP
Primary Outcome Measure Information:
Title
Participant Weight
Description
7% reduction in participant weight
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Minutes of Physical Activity
Description
Increase physical activity to 150 minutes per week.
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Anthony Jordan Health Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14605
Country
United States
Facility Name
Rochester General Medical Associates
City
Rochester
State/Province
New York
ZIP/Postal Code
14605
Country
United States
Facility Name
Unity Health System
City
Rochester
State/Province
New York
ZIP/Postal Code
14606
Country
United States
Facility Name
Westside Health Services
City
Rochester
State/Province
New York
ZIP/Postal Code
14611
Country
United States

12. IPD Sharing Statement

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Comparing Diabetes Prevention Programs

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