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
1 other identifier
interventional
207
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Sep 2006
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 8, 2010
CompletedFirst Posted
Study publicly available on registry
November 10, 2010
CompletedDecember 9, 2022
December 1, 2022
2.5 years
November 8, 2010
December 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Body mass index, blood pressure and lipid changes
Baseline, 4 months and 10 months
Study Arms (2)
Control group
PLACEBO COMPARATORThis arm continues with standard care at community clinic
Peer Education
EXPERIMENTALThis group receives 8 weeks of peer led self management education classes and subsequent monthly support groups for a total of 10 months
Interventions
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
This group continues with standard care at the community health center
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scripps Whittier Diabetes Institute
La Jolla, California, 92037, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Athena Philis-Tsimikas, MD
Scripps Whittier Diabetes Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Corp VP
Study Record Dates
First Submitted
November 8, 2010
First Posted
November 10, 2010
Study Start
September 1, 2006
Primary Completion
March 1, 2009
Study Completion
February 1, 2010
Last Updated
December 9, 2022
Record last verified: 2022-12