Diabetes Mellitus
Conditions
Keywords
Randomized Controlled Trial
Brief summary
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 randomized controlled trial (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.
Interventions
BEHAVIORALCommunity Health Worker (CHW) services
CHW services included access to an 11 week healthy lifestyle education curriculum, two home visits per month, two additional phone contacts per month, and accompanied participants to one clinic visit within the six month intervention period
Sponsors
Centers for Disease Control and Prevention
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| LDL cholesterol | 6 months |
| Blood pressure | 6 months |
| Diabetes self-management knowledge | 6 months |
| Diabetes Self Management and Self Care Activities (physical activity, healthy eating, glucose testing, medication taking, required screening tests/exams) | 6 months |
| Diabetes specific emotional distress | 6 months |
Countries
United States
Outcome results
None listed