Randomized Trial of Peer Led Education-Project Dulce

Scripps Whittier Diabetes Institute

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Control; Behavioral: Peer Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01238289

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

This arm continues with standard care at community clinic

Treatment:

Behavioral: Control

Peer Education

Experimental group

Description:

This group receives 8 weeks of peer led self management education classes and subsequent monthly support groups for a total of 10 months

Treatment:

Behavioral: Peer Education