About this trial
The goal of this study is to evaluate a Community Health Worker (CHW) program for people living with diabetes in rural areas or locations that are remote from the research team.
The study aims to answer the following questions:
1. Does the CHW program improve diabetes-related health outcomes, such as blood sugar control? 2. What is the sustainability of the program? 3. Is the program feasible and acceptable?
Participants will be invited to attend monthly diabetes education classes led by CHWs and receive weekly mobile health check-ins from CHWs for coaching and to help coordinate care with their clinic team.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Self-identified Hispanic Ethnicity
Spanish-speaking
Type 2 diabetes diagnosis, .g., physician documented diagnosis, HbA1c at least 6.5, treatment with a glucose-lowering agent
Disqualifiers
Condition known to alter HbA1c levels, e.g., recent transfusion, systemic steroids
Severe mental illness or cognitive impairment that would preclude participation in group activities
Pregnancy during the intervention period
Type 1 diabetes mellitus
Trial design
Single group
Treatments tested in this trial
Community Health Worker-led diabetes program
BehavioralThe intervention consists of four phases: (1) clinic readiness assessment, (2) CHW training, (3) tele-mentoring CHWs to deliver the 12-month diabetes program, and (4) sustainability assessment through 36 months.
Treatment groups
Trial outcomes
Primary outcomes
Change in Hemoglobin A1c (HbA1c)
Change in glycemic control measured by hemoglobin A1c (HbA1c). HbA1c values will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention HbA1c levels.
Secondary outcomes
Change in Blood Pressure
Change in systolic and diastolic blood pressure measured using standard clinical procedures. Blood pressure readings will be obtained at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention values.
Change in Cholesterol Levels
Change in lipid profile including total cholesterol, LDL, HDL, and triglycerides. Laboratory values will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention levels.
Change in Body Weight
Change in body weight measured in kilograms using a calibrated scale. Measurements will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention weight.
Change in Body Mass Index (BMI)
Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²). BMI will be assessed at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention BMI.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: