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Comparing Diabetes Prevention Programs

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ClinicalTrials.gov Identifier: NCT01409889
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Nancy Bennett, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Pre Diabetes Diabetes Behavioral: Diabetes Prevention Program Behavioral: Healthy Living Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparative Effectiveness of Practice-Based Diabetes Prevention Programs - A Pilot Study
Study Start Date : May 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Participant Weight [ Time Frame: 22 weeks ]
    7% reduction in participant weight


Secondary Outcome Measures :
  1. Minutes of Physical Activity [ Time Frame: 22 weeks ]
    Increase physical activity to 150 minutes per week.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409889


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

Responsible Party: Nancy Bennett, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01409889     History of Changes
Other Study ID Numbers: CTSI 5-27805
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016

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