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

Not Applicable

Completed

• Conditions: Diabetes; Depression
• Interventions: Behavioral: Social Services; Behavioral: Lifestyle; Behavioral: Lifestyle Plus Medication Therapy Management

• Registration Number: NCT02502929
• Lead Sponsor: UConn Health

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.

Study Timeline

• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Study Start: 2015-11
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social Services	Social Services	Participants in this arm will receive referrals for social services as indicated.
Lifestyle	Lifestyle	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.
Lifestyle plus Medication Therapy Management	Lifestyle Plus Medication Therapy Management	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.

Primary Outcome Measures

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

Trial Locations

Locations (3)

Uconn Health; 🇺🇸 Farmington, Connecticut, United States

Khmer Health Advocates; 🇺🇸 West Hartford, Connecticut, United States

Center for Southeast Asians; 🇺🇸 Providence, Rhode Island, United States