Randomized Trial of Peer Led Education-Project Dulce

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01238289

Enrollment

207

Registered

2010-11-10

Start date

2006-09-30

Completion date

2010-02-28

Last updated

2022-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

peer education, diabetes, randomized, trial

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.

Interventions

BEHAVIORALPeer 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

BEHAVIORALControl

This group continues with standard care at the community health center

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026