Randomized Trial of Peer Led Education-Project Dulce

December 7, 2022 updated by: Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute

Peer-Led Diabetes Education Programs in High Risk Mexican Americans Evaluates Glycemic Control Compared to Standard Approaches: A Project Dulce™ Promotora Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

207

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
    • California
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Institute

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

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Project Dulce

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 months and 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 4 months and 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Whittier Diabetes Institute

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
San Diego State University
National Center for Research Resources (NCRR)

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

September 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R18DK070666-01A1 (U.S. NIH Grant/Contract)

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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