Lifestyle and Medication Management to Lower Diabetes Risk in Severe Mental Illness
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- UConn Health
- Enrollment
- 182
- Locations
- 3
- Primary Endpoint
- Lifestyle risk for type 2 diabetes
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The primary aim of the study is to compare the effect of three different interventions on lifestyle risk factors and biological risk factors for type 2 diabetes in depressed Cambodians. The three different interventions are lifestyle, lifestyle plus medication therapy management, and social services.
Detailed Description
Cambodian Americans have high risk for major depressive disorder and for type 2 diabetes. Depression is a known risk factor for diabetes. Some antidepressants can also increase risk of diabetes by causing weight gain. DREAM will test the effect of lifestyle and medication therapy management (MTM) compared to social services (control) on diabetes risk among depressed Cambodian Americans. Community health workers (CHWs) will deliver the lifestyle intervention and assist pharmacists with MTM. Lifestyle and biological risk factors for diabetes, such as depressive symptoms, HbA1c and insulin sensitivity, will be measured before and after the interventions.
Investigators
Julie A. Wagner
Professor
UConn Health
Eligibility Criteria
Inclusion Criteria
- •Self-identified as Cambodian or Cambodian-American
- •Khmer speaking
- •Likely major depressive disorder
- •Elevated diabetes risk score per ADA guidelines
- •Ambulatory
- •Competent to give consent.
Exclusion Criteria
- •Pregnancy or plans to become pregnant in the next 2 years
- •Previous diagnosis of diabetes
- •Seeing or hearing problems that would interfere with group sessions
- •Currently being followed by a physician for major medical problem
- •Serious thinking or memory problems (e.g., schizophrenia or dementia)
- •3 or more days in a psychiatric hospital or self-harm in the past 2 years.
Outcomes
Primary Outcomes
Lifestyle risk for type 2 diabetes
Time Frame: 12 months and 15 months
Change from baseline in depressive symptoms according to the Hopkins Symptom Checklist
Biological risk for type 2 diabetes
Time Frame: 12 months and 15 months
Change from baseline in HbA1c and insulin resistance according to logHOMA-IR