Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 Diabetes
Brief summary
The primary aims of this study are to: 1. Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population. 2. Investigate the efficacy of the stress management intervention on glycemic control. Secondary aims of this study are to: 3. Investigate the efficacy of the stress management intervention on stress hormones, psychosocial functioning, and stress-glucose reactivity. Study hypothesis: A CHW-led group-based diabetes education model enhanced with stress management education will improve glycemic control more than CHW-led group-based diabetes education alone.
Interventions
The study is a randomized, controlled,single-site, parallel group clinical trial comparing the effectiveness of CHW led diabetes education with CHW led diabetes education plus CHW led stress management in Latinos with Type 2 Diabetes.
Sponsors
Study design
Eligibility
Inclusion criteria
* Latinos age 18 or older that are ambulatory * Spanish speaking * Diagnosed with type 2 diabetes for at least 1 year * Hemoglobin A1c levels greater than 7.0
Exclusion criteria
* Medical instability or medical treatment requiring inpatient care * Diagnoses of bipolar disorder or thought disorder (or taking medications prescribed for either); current substance abuse or dependence disorder * Current suicidality or history of suicide attempt * History of psychiatric hospitalization * Taking antidepressant medications prescribed for the treatment of depression accompanied by either a) changes to the antidepressant regimen within previous 6 weeks, or b) anticipated changes to the regimen during period of study. Such patients will be deferred and re-evaluated for eligibility after 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | Baseline | Blood will be drawn from participants and hemoglobin A1c levels will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes specific distress | Baseline | Participants will be asked questions assessing their perspective of emotional distress from living with diabetes |
Countries
United States