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

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ClinicalTrials.gov Identifier: NCT02502929
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Khmer Health Advocates
University of Connecticut
Penn State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Julie A. Wagner, 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 enhanced standard care.

Condition or disease Intervention/treatment Phase
Diabetes Depression Behavioral: Enhanced standard care Behavioral: Lifestyle Behavioral: Lifestyle Plus Medication Therapy Management Not Applicable

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 depression by causing weight gain. DREAM will test the effect of lifestyle and medication therapy management (MTM) 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 and insulin sensitivity, will be measured before and after the interventions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Lifestyle and Medication Management to Lower Diabetes Risk in Severe Mental Illness
Actual Study Start Date : November 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Enhanced standard care
Participants in this arm will receive referrals for medical and social services as indicated.
Behavioral: Enhanced standard care
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



Primary Outcome Measures :
  1. Lifestyle risk for type 2 diabetes [ Time Frame: 15 months ]
    Depressive symptoms according to the Hopkins Symptom Checklist

  2. Biological risk for type 2 diabetes [ Time Frame: 15 months ]
    Insulin resistance according to logHOMA-IR



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-identified as Cambodian or Cambodian-American
  • Khmer speaking
  • Major depressive disorder
  • Elevated diabetes risk score per ADA guidelines
  • >= 3 medications
  • Ambulatory
  • Competent to give consent.

Exclusion Criteria:

  • Pregnancy or plans to become pregnant in the next 2 years
  • Previous diagnosis of diabetes
  • Vision or hearing problems that would prevent participation in group sessions
  • Currently being followed by a physician for major medical problem
  • Currently being followed by a healthcare provider for major psychiatric problem other than depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502929


Contacts
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Contact: Julie A Wagner, PhD 860-679-4508 juwagner@uchc.edu
Contact: Kara B Dion, BA 860-679-4767 kdion@uchc.edu

Locations
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United States, Connecticut
Uconn Health Recruiting
Farmington, Connecticut, United States, 06030
Contact: Julie Wagner, PhD    860-679-4508      
Khmer Health Advocates Recruiting
West Hartford, Connecticut, United States, 06110
Contact: Mary Scully    860-561-3345    mfs47@aol.com   
United States, Rhode Island
Center for Southeast Asians Recruiting
Providence, Rhode Island, United States, 02907
Contact: Channavy Chhay    401-274-8811 ext x12    channavy.chhay@cseari.org   
Sponsors and Collaborators
UConn Health
Khmer Health Advocates
University of Connecticut
Penn State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Julie A Wagner, PhD UConn Health

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Responsible Party: Julie A. Wagner, Associate Professor, UConn Health
ClinicalTrials.gov Identifier: NCT02502929     History of Changes
Other Study ID Numbers: 15-164S-3
5R01DK103663 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

Keywords provided by Julie A. Wagner, UConn Health:
Diabetes
Depression
Medication therapy management
Community health workers
Cambodian
Refugee
Prevention

Additional relevant MeSH terms:
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Diabetes Mellitus
Depression
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms