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

February 2, 2021 updated by: Julie A. Wagner, UConn Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UConn Health
      • West Hartford, Connecticut, United States, 06110
        • Khmer Health Advocates
    • Rhode Island
      • Providence, Rhode Island, United States, 02907
        • Center for Southeast Asians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Social Services
Participants in this arm will receive referrals for social services as indicated.
Behavioral: Social Services
Experimental: 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.
Behavioral: Lifestyle
Experimental: 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.
Behavioral: Lifestyle Plus Medication Therapy Management

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Penn State University
Khmer Health Advocates

Investigators

  • Principal Investigator: Julie A Wagner, PhD, UConn Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-164S-3
  • 5R01DK103663 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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