DiabetesDREAMNCT02502929
Diabetes Risk Reduction Through Eat, Walk, Sleep and Medication Therapy Management for Depressed Cambodians
A study testing Social Services, Lifestyle and Lifestyle Plus Medication Therapy Management in people with Diabetes and Depression, run by UConn Health at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes, Depression
- What is being tested?
- Social Services, Lifestyle and Lifestyle Plus Medication Therapy Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Uconn Health
Farmington, Connecticut, 06030
Center for Southeast Asians
Providence, Rhode Island, 02907
Khmer Health Advocates
West Hartford, Connecticut, 06110
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes, Depression
- Being tested
- Social Services, Lifestyle, Lifestyle Plus Medication Therapy Management
- Keywords
- Diabetes, Depression, Medication therapy management, Community health workers, Cambodian, Refugee, Prevention
- Medical subject headings
- Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social ServicesBehavioural
LifestyleBehavioural
Lifestyle Plus Medication Therapy ManagementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Social Services | Active comparator | Participants in this arm will receive referrals for social services as indicated. Receives: Behavioral: Social Services |
| Lifestyle | Experimental | 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. Receives: Behavioral: Lifestyle |
| Lifestyle plus Medication Therapy Management | Experimental | 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. Receives: Behavioral: Lifestyle Plus Medication Therapy Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle risk for type 2 diabetes
Change from baseline in depressive symptoms according to the Hopkins Symptom Checklist
Measured: 12 months and 15 months
Biological risk for type 2 diabetes
Change from baseline in HbA1c and insulin resistance according to logHOMA-IR
Measured: 12 months and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Khmer Health Advocates, Penn State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Julie A. Wagner, UConn Health
- Investigators
- Julie A Wagner, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502929
- Sponsor's protocol ID
- 15-164S-3
- Other IDs
- 5R01DK103663
- Acronym
- DREAM
- Status last verified
- Feb 2021
- First submitted
- 16 Jul 2015
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37700288Wagner 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.
PubMed 36307274Wagner 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.
PubMed 35087696Wagner 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.
PubMed 33957272
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle and Medication Management to Lower Diabetes Risk in Severe Mental Illness
- ClinicalTrials.gov ID
- NCT02502929
- Acronym / sponsor ID
- DREAM / 15-164S-3
- Conditions
- Diabetes, Depression
- Keywords
- Diabetes, Depression, Medication therapy management, Community health workers, Cambodian, Refugee, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Khmer Health Advocates, Penn State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social Services | Active comparator | Behavioral: Social ServicesParticipants in this arm will receive referrals for social services as indicated. |
| Lifestyle | Experimental | Behavioral: LifestyleParticipants 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 | Experimental | Behavioral: Lifestyle Plus Medication Therapy ManagementParticipants 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identified as Cambodian or Cambodian-American
- Khmer speaking
- Likely major depressive disorder
- Elevated diabetes risk score per ADA guidelines
- Ambulatory
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Services | Behavioural | Social Services |
| Lifestyle | Behavioural | Lifestyle |
| Lifestyle Plus Medication Therapy Management | Behavioural | Lifestyle plus Medication Therapy Management |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Derived from this study: PubMed 37700288Wagner 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.
- Derived from this study: PubMed 36307274Wagner 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.
- Derived from this study: PubMed 35087696Wagner 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.
- Derived from this study: PubMed 33957272Wagner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Wagner, PhD principal investigator
UConn Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Services, Lifestyle and Lifestyle Plus Medication Therapy Management in people with Diabetes and Depression, run by UConn Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifestyle risk for type 2 diabetes (time frame: 12 months and 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502929, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.