Diabetes Risk Reduction Through Eat, Walk, Sleep and Medication Therapy Management for Depressed Cambodians
DREAM
Lifestyle and Medication Management to Lower Diabetes Risk in Severe Mental Illness
2 other identifiers
interventional
182
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Nov 2015
Longer than P75 for not_applicable diabetes
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2015
CompletedFirst Posted
Study publicly available on registry
July 20, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedFebruary 5, 2021
February 1, 2021
4.8 years
July 16, 2015
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Lifestyle risk for type 2 diabetes
Change from baseline in depressive symptoms according to the Hopkins Symptom Checklist
12 months and 15 months
Biological risk for type 2 diabetes
Change from baseline in HbA1c and insulin resistance according to logHOMA-IR
12 months and 15 months
Study Arms (3)
Social Services
ACTIVE COMPARATORParticipants in this arm will receive referrals for social services as indicated.
Lifestyle
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- or more days in a psychiatric hospital or self-harm in the past 2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UConn Healthlead
- Khmer Health Advocatescollaborator
- Penn State Universitycollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
Study Sites (3)
Uconn Health
Farmington, Connecticut, 06030, United States
Khmer Health Advocates
West Hartford, Connecticut, 06110, United States
Center for Southeast Asians
Providence, Rhode Island, 02907, United States
Related Publications (4)
Wagner JA, Bermudez-Millan A, Buckley TE, Buxton OM, Feinn RS, Kong S, Kuoch T, Master L, Scully MF. Secondary analysis of a randomized trial testing community health educator interventions for diabetes prevention among refugees with depression: effects on nutrition, physical activity and sleep. Int J Behav Nutr Phys Act. 2023 Sep 12;20(1):107. doi: 10.1186/s12966-023-01509-y.
PMID: 37700288DERIVEDWagner J, Bermudez-Millan A, Buckley T, Buxton OM, Feinn R, Kong S, Kuoch T, Nye LM, Scully M. Self-reported outcomes of a randomized trial comparing three community health worker interventions for diabetes prevention among Cambodian Americans with depression. Patient Educ Couns. 2022 Dec;105(12):3501-3508. doi: 10.1016/j.pec.2022.09.011. Epub 2022 Oct 6.
PMID: 36307274DERIVEDWagner JA, Bermudez-Millan A, Berthold SM, Buckley T, Buxton OM, Feinn R, Kuoch T, Kong S, Lim M, Polomoff C, Scully M. Risk factors for drug therapy problems among Cambodian Americans with complex needs: a cross-sectional, observational study. Health Psychol Behav Med. 2022 Jan 24;10(1):145-159. doi: 10.1080/21642850.2021.2021917. eCollection 2022.
PMID: 35087696DERIVEDWagner J, Bermudez-Millan A, Buckley T, Buxton OM, Feinn R, Kong S, Kuoch T, Nahmod NG, Scully M. A randomized trial to decrease risk for diabetes among Cambodian Americans with depression: Intervention development, baseline characteristics and process outcomes. Contemp Clin Trials. 2021 Jul;106:106427. doi: 10.1016/j.cct.2021.106427. Epub 2021 May 3.
PMID: 33957272DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie A Wagner, PhD
UConn Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 16, 2015
First Posted
July 20, 2015
Study Start
November 1, 2015
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
February 5, 2021
Record last verified: 2021-02