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

Depression Clinical Trial

— DREAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502929
• Other study ID #: 15-164S-3
• Secondary ID: 5R01DK103663
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: September 2020

Study information

• Verified date: February 2021
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Diabetes
• Diabetes Mellitus

Intervention

Behavioral:
• Social Services

• Lifestyle

• Lifestyle Plus Medication Therapy Management

Locations

Country	Name	City	State
United States	Uconn Health	Farmington	Connecticut
United States	Center for Southeast Asians	Providence	Rhode Island
United States	Khmer Health Advocates	West Hartford	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
UConn Health	Khmer Health Advocates, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Penn State University

Country where clinical trial is conducted

United States, 

Outcome

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