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Randomized Trial of Peer Led Education-Project Dulce

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01238289
First received: November 8, 2010
Last updated: January 5, 2011
Last verified: November 2010
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
 Behavioral: Peer Education
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Scripps Whittier Diabetes Institute:

Primary Outcome Measures:
  • mean percent change Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 4 months and 10 months ] [ Designated as safety issue: No ]
    Evaluate change in HbA1c over a 10 month time period from baseline.


Secondary Outcome Measures:
  • Body mass index, blood pressure and lipid changes [ Time Frame: Baseline, 4 months and 10 months ] [ Designated as safety issue: No ]
    Evaluate change in Body mass index, blood pressure and lipids over a 10 month time period from baseline


Enrollment: 207
Study Start Date: September 2006
Study Completion Date: February 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier: NCT01238289     History of Changes
Other Study ID Numbers: R18 DK070666-01A1, R18DK070666-01A1
Study First Received: November 8, 2010
Last Updated: January 5, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013