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

  • United States
    • 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
Behavioral: Diabetes Prevention Program
Other Names:
  • DPP
Active Comparator: Healthy Living Program
Individuals in this group will receive the Healthy Living Program
Behavioral: Healthy Living Program
Other Names:
  • HLP

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

University of Rochester

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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