Diabetes Risk Reduction Through Eat, Walk, Sleep and Medication Therapy Management for Depressed Cambodians
NCT ID: NCT02502929
Last Updated: 2021-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
182 participants
INTERVENTIONAL
2015-11-30
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Social Services
Participants in this arm will receive referrals for social services as indicated.
Social Services
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
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.
Lifestyle Plus Medication Therapy Management
Interventions
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Social Services
Lifestyle
Lifestyle Plus Medication Therapy Management
Eligibility Criteria
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Inclusion Criteria
* Khmer speaking
* Likely major depressive disorder
* Elevated diabetes risk score per ADA guidelines
* Ambulatory
* Competent to give consent.
Exclusion Criteria
* 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.
35 Years
75 Years
ALL
No
Sponsors
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Khmer Health Advocates
UNKNOWN
Penn State University
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
UConn Health
OTHER
Responsible Party
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Julie A. Wagner
Professor
Principal Investigators
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Julie A Wagner, PhD
Role: PRINCIPAL_INVESTIGATOR
UConn Health
Locations
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Uconn Health
Farmington, Connecticut, United States
Khmer Health Advocates
West Hartford, Connecticut, United States
Center for Southeast Asians
Providence, Rhode Island, United States
Countries
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References
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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.
Wagner 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.
Wagner 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.
Wagner 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.
Other Identifiers
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15-164S-3
Identifier Type: -
Identifier Source: org_study_id
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