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Behavioral Intervention

Multi-component Intervention for Diabetes in Adults With Serious Mental Illness (MIDAS Trial)

N/A
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 9 months and sustained at 15 months
Awards & highlights
No Placebo-Only Group

Summary

Persons with schizophrenia and other serious mental illnesses have a high risk for type 2 diabetes and an increased risk of premature mortality compared to the general population. The goals of the proposed study are to implement a multimodal lifestyle intervention to reduce that risk in these individuals living in residential care facilities, a common housing modality for people with serious mental illnesses. If successful, this intervention will lead to reduction in excess medical comorbidity and mortality in persons with serious mental illnesses.

Eligible Conditions
  • Schizophrenia
  • Diabetes
  • Lifestyle Risk Reduction
  • Serious Mental Illness
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 9 months and sustained at 15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 9 months and sustained at 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Mass Index (BMI in kg/m^2)
Fasting Glucose
Hemoglobin A1c or HbA1c
+1 more
Secondary study objectives
Diet/Nutrition - Plasma Carotenoid Levels
Diet/Nutrition - Serum Lipid Levels
Objective Measure of Physical Activity
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention PhaseExperimental Treatment1 Intervention
6-month intervention phase - MIDAS Intervention Delivered. Followed by 6-month follow-up phase (no intervention, months 10-15).
Group II: Control PhaseActive Control1 Intervention
3-month initial control phase (no intervention, month 1-3)

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Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,187 Previous Clinical Trials
1,576,565 Total Patients Enrolled
28 Trials studying Schizophrenia
5,714 Patients Enrolled for Schizophrenia
~30 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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