- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03627377
Multi-component Intervention for Diabetes in Adults With Serious Mental Illness (MIDAS)
Multi-component Intervention for Diabetes in Adults With Serious Mental Illness (MIDAS)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dilip V Jeste, MD
- Phone Number: (858) 534-4020
- Email: djeste@ucsd.edu
Study Contact Backup
- Name: Danielle K Glorioso, LCSW
- Phone Number: (858) 246-0767
- Email: dglorioso@ucsd.edu
Study Locations
-
-
California
-
La Jolla, California, United States, 92093
- Recruiting
- University of California, San Diego Division of Geriatric Psychiatry
-
Contact:
- Danielle K Glorioso, LCSW
- Phone Number: 858-246-0767
- Email: dglorioso@ucsd.edu
-
Contact:
- Cynthia Ibarra, MA
- Phone Number: (858) 822-6005
- Email: cyibarra@ucsd.edu
-
Principal Investigator:
- Dilip V Jeste, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Participants: A total of 12 RCFs (30 to 45 beds each), 210 resident participants, and 120 staff members (1 manager, 2 activity directors, 1 cook, and 6 other staff members per facility) will be enrolled.
Inclusion and Exclusion Criteria:
Residential Care Facilities (RCFs):
Inclusion Criteria:
- Licensed by California Division of Social Services' Community Care Licensing
- Serves only individuals with SMI
- Has >15 residents currently living in the facility
- Willing to participate
Staff Participants:
Inclusion Criteria:
- Age >21 years
- Fluent in English
- Written informed consent to participate
Exclusion Criteria:
(1) Plans to leave the RCF during the next year.
Resident Participants:
Inclusion Criteria:
- Age 18 - 65 years
- Chart diagnosis of an SMI, mainly schizophrenia, schizoaffective disorder, or bipolar disorder
- Current treatment with antipsychotics
- Fluent in English
- Written informed consent to participate in this study
Exclusion Criteria:
- Chart diagnosis of dementia or intellectual disability disorder
- Active substance abuse (non-tobacco)
- Medical problems that interfere with ability to complete assessments and intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Phase
3-month initial control phase (no intervention, month 1-3)
|
|
Experimental: Intervention Phase
6-month intervention phase - MIDAS Intervention Delivered.
Followed by 6-month follow-up phase (no intervention, months 10-15).
|
Main components of MIDAS include: (1) Education about diabetes and lifestyle, (2) Dietary intervention at the facility and resident level, (3) Increased physical activity, and (4) Smoking cessation / reduction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index (BMI in kg/m^2)
Time Frame: Baseline to 9 months and sustained at 15 months
|
Change in Body Mass Index
|
Baseline to 9 months and sustained at 15 months
|
Waist Circumference
Time Frame: Baseline to 9 months and sustained at 15 months
|
Change in Waist Circumference
|
Baseline to 9 months and sustained at 15 months
|
Fasting Glucose
Time Frame: Baseline to 9 months and sustained at 15 months
|
Change in Fasting Glucose
|
Baseline to 9 months and sustained at 15 months
|
Hemoglobin A1c or HbA1c
Time Frame: Baseline to 9 months and sustained at 15 months
|
Change in Hemoglobin A1c or HbA1c
|
Baseline to 9 months and sustained at 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diet/Nutrition - Plasma Carotenoid Levels
Time Frame: Baseline to 9 months and sustained at 15 months
|
Plasma Carotenoid levels reflect changing dietary vegetable and fruit intake.Nutrition Data Systems for REsearch (NDS-R) Protocol
|
Baseline to 9 months and sustained at 15 months
|
Diet/Nutrition - Serum Lipid Levels
Time Frame: Baseline to 9 months and sustained at 15 months
|
Plasma Carotenoid levels reflect changing dietary vegetable and fruit intake.
|
Baseline to 9 months and sustained at 15 months
|
Objective Measure of Physical Activity
Time Frame: Baseline to 9 months and sustained at 15 months
|
For 7 days during each assessment period, participants will wear the GT3X+ Actigraph, which measures movement and intensity of activity, and has good validation with VO2max.
It provides estimates of activity by seconds, that can be categorized into minutes spent in sedentary, light, moderate, and vigorous activity using calibration thresholds.
|
Baseline to 9 months and sustained at 15 months
|
Smoking - Expired Breath Carbon Monoxide (CO) Levels
Time Frame: Baseline to 9 months and sustained at 15 months
|
Change in Smoking - Objective Measure of Cigarette Use: Expired Breath Carbon Monoxide (CO) level (parts per million) is measured with a handheld device.
CO monitoring is used primarily as a check on recent smoking, though it has also been used to indicate reductions in smoking.
|
Baseline to 9 months and sustained at 15 months
|
Smoking - Change in Smoking through Recall
Time Frame: Baseline to 9 months and sustained at 15 months
|
Change in Smoking - Quantity and frequency of cigarette use for the prior week using a timeline followback procedure.
Smoking reduction calculated by % change in average cigarettes/day across assessments.
|
Baseline to 9 months and sustained at 15 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH15127
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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