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Randomized Trial of Peer Led Education-Project Dulce

NCT ID: NCT01238289

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Keywords

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peer education diabetes randomized trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control group

This arm continues with standard care at community clinic

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

This group continues with standard care at the community health center

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

Group Type EXPERIMENTAL

Peer Education

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Control

This group continues with standard care at the community health center

Intervention Type BEHAVIORAL

Other Intervention Names

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Project Dulce

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

San Diego State University

OTHER

Sponsor Role collaborator

Scripps Whittier Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

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Athena Philis-Tsimikas

Corp VP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Athena Philis-Tsimikas, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Whittier Diabetes Institute

Locations

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Scripps Whittier Diabetes Institute

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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R18DK070666-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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R18DK070666-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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