A Pilot Randomized Diabetes Intervention Among Inner-City African American and Latino Adults

The objectives of the proposed study are to determine whether culturally diverse community residents with diabetes are willing to participate in our community health worker intervention using RCT methods and to explore and document effective processes and protocols for RCT methods in these communities. The investigators will examine retention rates, identify reasons for attrition through interviews and focus groups, and determine strategies for improving recruitment, retention, and intervention methods. As a secondary objective, the investigators will explore the potential impacts of the intervention for improving healthy lifestyles, diabetes self-management, and selected health outcomes of participants.

Status: Completed (Phase 2). Started on September 1st, 2004. Ended on July 1st, 2006.

Enrollment: 183 subjects

Study Type: Interventional

Study Design:

Supportive Care
Randomized
Open Label
Parallel Assignment
Safety/Efficacy Study

Conditions:

Diabetes Mellitus

Interventions:

Behavioral: Community Health Worker (CHW) services

Eligibility

Inclusion Criteria:

At least 18 years of age
Had physician-diagnosed type 2 diabetes
Self-identified as African American or Latino/Hispanic
Lived in the targeted zip codes.

Exclusion Criteria:

Individuals who already had serious diabetes-related complications, such as blindness, amputated limbs, and kidney failure

Gender: Both
Mininum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No

Resources

Source: University of Michigan

Authority: United States: Federal Government

Locations

Community Health and Social Services (CHASS)
Detroit
Michigan
48209
United States

Officials

Michael S Spencer, PhD, MSW (Principal Investigator, University of Michigan)

References

None.

Links

None.

Date Verified: October 1st, 2008
First Received: December 1st, 2008
Last Changed: December 1st, 2008

Information obtained from ClinicalTrials.gov on December 02, 2008. Link to the current ClinicalTrials.gov record.

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