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

UConn Health

Status: Completed

Conditions: Diabetes; Depression

Treatments: Behavioral: Lifestyle; Behavioral: Lifestyle Plus Medication Therapy Management; Behavioral: Social Services

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02502929

5R01DK103663 (U.S. NIH Grant/Contract)

15-164S-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 3 patient groups

Social Services

Active Comparator group

Description:

Participants in this arm will receive referrals for social services as indicated.

Treatment:

Behavioral: Social Services

Lifestyle

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle

Lifestyle plus Medication Therapy Management

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle Plus Medication Therapy Management