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Completed

NCT Number: NCT01238289

Randomized Trial of Peer Led Education-Project Dulce

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Education

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

Other names: Project Dulce

Control

Behavioral

This group continues with standard care at the community health center

Primary outcomes

  1. mean percent change Hemoglobin A1c (HbA1c)

    Time frame: Baseline, 4 months and 10 months

    Evaluate change in HbA1c over a 10 month time period from baseline.

Secondary outcomes

  1. Body mass index, blood pressure and lipid changes

    Time frame: Baseline, 4 months and 10 months

    Evaluate change in Body mass index, blood pressure and lipids over a 10 month time period from baseline

Sponsors and collaborators

Lead sponsor

Scripps Whittier Diabetes Institute

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • San Diego State University

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Nov 10, 2010
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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