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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02502929
Acronym
DREAM
Enrollment
182
Registered
2015-07-20
Start date
2015-11-30
Completion date
2020-09-30
Last updated
2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Diabetes

Keywords

Diabetes, Depression, Medication therapy management, Community health workers, Cambodian, Refugee, Prevention

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.

Interventions

BEHAVIORALSocial Services
BEHAVIORALLifestyle
BEHAVIORALLifestyle Plus Medication Therapy Management

Sponsors

Khmer Health Advocates
CollaboratorUNKNOWN
Penn State University
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
UConn Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lifestyle risk for type 2 diabetes12 months and 15 monthsChange from baseline in depressive symptoms according to the Hopkins Symptom Checklist
Biological risk for type 2 diabetes12 months and 15 monthsChange from baseline in HbA1c and insulin resistance according to logHOMA-IR

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026