Clinical trial NCT02502929: Diabetes Risk Reduction Through Eat, Walk, Sleep and Medication Therapy Management for Depressed Cambodians
Official title: Lifestyle and Medication Management to Lower Diabetes Risk in Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Depression
Keywords: Diabetes
Depression
Medication therapy management
Community health workers
Cambodian
Refugee
Prevention
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Khmer Health Advocates
name: Penn State University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-07-20
Enrollment: 182
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lifestyle risk for type 2 diabetes
timeFrame: 12 months and 15 months
measure: Biological risk for type 2 diabetes
timeFrame: 12 months and 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Uconn Health
state: Connecticut
city: West Hartford
country: United States
facility: Khmer Health Advocates
state: Connecticut
city: Providence
country: United States
facility: Center for Southeast Asians
state: Rhode Island
Study officials:
affiliation: UConn Health
name: Julie A Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.