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Randomized Trial of Peer Led Education-Project Dulce

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ClinicalTrials.gov Identifier: NCT01238289
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : January 6, 2011
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
San Diego State University
Information provided by:
Scripps Whittier Diabetes Institute

Brief Summary:
The purpose of this study is to evaluate the effect of a culturally sensitive diabetes self-management program on glucose control and metabolic parameters in low income Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost, peer-educator format.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Peer Education Behavioral: Control Not Applicable

Detailed Description:
To recruit 207 Mexican-Americans patients from federally-funded community health centers in San Diego County with Hemoglobin A1c (HbA1c) > 8% and randomize to Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome will be the percent change in HbA1c levels at 10 months following randomization.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Peer-Led Diabetes Education Programs in High Risk Mexican Americans Evaluates Glycemic Control Compared to Standard Approaches: A Project Dulce™ Promotora Randomized Trial
Study Start Date : September 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Placebo Comparator: Control group
This arm continues with standard care at community clinic
Behavioral: Control
This group continues with standard care at the community health center
Experimental: Peer Education
This group receives 8 weeks of peer led self management education classes and subsequent monthly support groups for a total of 10 months
Behavioral: Peer Education
Conduct peer education classes for 8 weeks and support groups monthly for a total of 10 months and evaluate effects on metabolic and behavior outcomes
Other Name: Project Dulce



Primary Outcome Measures :
  1. mean percent change Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 4 months and 10 months ]
    Evaluate change in HbA1c over a 10 month time period from baseline.


Secondary Outcome Measures :
  1. Body mass index, blood pressure and lipid changes [ Time Frame: Baseline, 4 months and 10 months ]
    Evaluate change in Body mass index, blood pressure and lipids over a 10 month time period from baseline



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mexican American, men and women, 21-75 years old, who were under-insured patients at federally qualified community health centers in San Diego County with type 2 diabetes and HbA1c > or = 8%.

Exclusion Criteria:

  • Individuals with a physical or mental health condition that would preclude fulfilling the requirements of the study were ineligible to participate, HbA1c < 8,pregnant with gestational diabetes

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): NCT01238289


Locations
United States, California
Scripps Whittier Diabetes Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Whittier Diabetes Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
San Diego State University
Investigators
Principal Investigator: Athena Philis-Tsimikas, MD Scripps Whittier Diabetes Institute

Responsible Party: Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier: NCT01238289     History of Changes
Other Study ID Numbers: R18DK070666-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: November 2010

Keywords provided by Scripps Whittier Diabetes Institute:
peer education
diabetes
randomized
trial

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases