Randomized Trial of Peer Led Education-Project Dulce

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238289
• Other study ID #: R18DK070666-01A1
• Secondary ID: R18DK070666-01A1
• Status: Completed
• Phase: N/A
• Start date: September 2006
• Est. completion date: February 2010

Study information

• Verified date: December 2022
• Source: Scripps Whittier Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

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
• Control
This group continues with standard care at the community health center

Locations

Country	Name	City	State
United States	Scripps Whittier Diabetes Institute	La Jolla	California

Sponsors (4)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute	National Center for Research Resources (NCRR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean percent change Hemoglobin A1c (HbA1c)	Evaluate change in HbA1c over a 10 month time period from baseline.	Baseline, 4 months and 10 months
Secondary	Body mass index, blood pressure and lipid changes	Evaluate change in Body mass index, blood pressure and lipids over a 10 month time period from baseline	Baseline, 4 months and 10 months