Randomized Trial of Peer Led Education-Project Dulce

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Control; Behavioral: Peer Education

• Registration Number: NCT01238289
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-09
• Primary Completion: 2009-03
• Study Completion: 2010-02
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control	This arm continues with standard care at community clinic
Peer Education	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

Primary Outcome Measures

Name	Time	Method
mean percent change Hemoglobin A1c (HbA1c)	Baseline, 4 months and 10 months	Evaluate change in HbA1c over a 10 month time period from baseline.

Secondary Outcome Measures

Name	Time	Method
Body mass index, blood pressure and lipid changes	Baseline, 4 months and 10 months	Evaluate change in Body mass index, blood pressure and lipids over a 10 month time period from baseline

Trial Locations

Locations (1)

Scripps Whittier Diabetes Institute; 🇺🇸 La Jolla, California, United States