Recruiting

Diabetes Intervention

Sponsor:

UCLA

Code:

NCT03627377

Conditions

Schizophrenia

Obesity

Diabetes

Lifestyle Risk Reduction

Serious Mental Illness

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Multi-component Intervention for Diabetes in Adults with Serious Mental Illness

Study Details

Brief 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.

Conditions

Schizophrenia

Obesity

Diabetes

Lifestyle Risk Reduction

Serious Mental Illness

Study ID

NCT03627377

Start date

Dec 28, 2018

Status verified date

Sep, 2021

Completion date

May 31, 2022

Anticipated

Primary completion date

May 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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:

1. Licensed by California Division of Social Services' Community Care Licensing
2. Serves only individuals with SMI
3. Has >15 residents currently living in the facility
4. Willing to participate

Staff Participants:

Inclusion Criteria:

1. Age >21 years
2. Fluent in English
3. Written informed consent to participate

Exclusion Criteria:

(1) Plans to leave the RCF during the next year.

Resident Participants:

Inclusion Criteria:

1. Age 18 - 65 years
2. Chart diagnosis of an SMI, mainly schizophrenia, schizoaffective disorder, or bipolar disorder
3. Current treatment with antipsychotics
4. Fluent in English
5. Written informed consent to participate in this study

Exclusion Criteria:

1. Chart diagnosis of dementia or intellectual disability disorder
2. Active substance abuse (non-tobacco)
3. Medical problems that interfere with ability to complete assessments and intervention

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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).

Interventions

Multi-component Intervention for Diabetes in Adults with Serious Mental Illness

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.

Primary outcome measure

  • Body Mass Index (BMI in kg/m^2) [ Time Frame: Baseline to 9 months and sustained at 15 months ]
  • Waist Circumference [ Time Frame: Baseline to 9 months and sustained at 15 months ]
  • Fasting Glucose [ Time Frame: Baseline to 9 months and sustained at 15 months ]
  • Hemoglobin A1c or HbA1c [ Time Frame: Baseline to 9 months and sustained at 15 months ]

Central Contacts and Locations

Central contacts

Dilip V Jeste, MD

(858) 534-4020djeste@ucsd.edu

Danielle K Glorioso, LCSW

(858) 246-0767dglorioso@ucsd.edu

Locations

University of California, San Diego Division of Geriatric Psychiatry

Recruiting

La Jolla, California, United States, 92093

Contacts

Danielle K Glorioso, LCSW

858-246-0767dglorioso@ucsd.edu

Cynthia Ibarra, MA

(858) 822-6005cyibarra@ucsd.edu

Principal Investigator:

Dilip V Jeste, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Sep 17, 2021

Last verified

Sep, 2021

Keywords

  • Schizophrenia
  • Serious mental illness
  • Obesity
  • Diabetes
  • Lifestyle Risk Reduction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2021-09-17.