Diabetes Risk Reduction Through Eat, Walk, Sleep and Medication Therapy Management for Depressed Cambodians

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lifestyle and Medication Management to Lower Diabetes Risk in Severe Mental Illness

Conditions
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Diabetes, Depression

Intervention / Treatment
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* Behavioral: Social Services
* Behavioral: Lifestyle
* Behavioral: Lifestyle Plus Medication Therapy Management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Social Services<br>Participants in this arm will receive referrals for social services as indicated. | Behavioral: Social Services<br> <br> |
| Experimental: Lifestyle<br>Participants in this arm will receive lifestyle modification from community health workers using the manualized lifestyle intervention called Eat, Walk, Sleep. They will receive individual home visits, health activity group sessions, and supportive phone calls. | Behavioral: Lifestyle<br> <br> |
| Experimental: Lifestyle plus Medication Therapy Management<br>Participants in this arm will receive everything in the Lifestyle arm, plus Medication Therapy Management (MTM). Participants will receive MTM from a pharmacist via telemedicine with the assistance of a community health worker. | Behavioral: Lifestyle Plus Medication Therapy Management<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifestyle risk for type 2 diabetes | Change from baseline in depressive symptoms according to the Hopkins Symptom Checklist | 12 months and 15 months | 
| Biological risk for type 2 diabetes | Change from baseline in HbA1c and insulin resistance according to logHOMA-IR | 12 months and 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Depression, Medication therapy management, Community health workers, Cambodian, Refugee, Prevention