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Comparing Diabetes Prevention Programs

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT01409889
First received: August 2, 2011
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Pre Diabetes
Diabetes
 Behavioral: Diabetes Prevention Program
Behavioral: Healthy Living Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparative Effectiveness of Practice-Based Diabetes Prevention Programs - A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Participant Weight [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
    7% reduction in participant weight


Secondary Outcome Measures:
  • Minutes of Physical Activity [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
    Increase physical activity to 150 minutes per week.


Enrollment: 92
Study Start Date: May 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diabetes Prevetion Program
Individuals in this group will receive the Diabetes Prevention Program
 Behavioral: Diabetes Prevention Program
Other Name: DPP
Active Comparator: Healthy Living Program
Individuals in this group will receive the Healthy Living Program
 Behavioral: Healthy Living Program
Other Name: HLP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409889

Locations
United States, New York
Unity Health System
Rochester, New York, United States, 14606
Westside Health Services
Rochester, New York, United States, 14611
Rochester General Medical Associates
Rochester, New York, United States, 14605
Anthony Jordan Health Center
Rochester, New York, United States, 14605
Sponsors and Collaborators
University of Rochester
  More Information

No publications provided

Responsible Party: Nancy M. Bennett, Principle Investigator, Univeristy of Rochester - Director for the Center for Community Health
ClinicalTrials.gov Identifier: NCT01409889     History of Changes
Other Study ID Numbers: CTSI 5-27805
Study First Received: August 2, 2011
Last Updated: November 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on May 19, 2013