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

NCT03627377 | Unknown

• 1 other identifier: MH15127
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Body Mass Index (BMI in kg/m^2)

  Change in Body Mass Index

  Baseline to 9 months and sustained at 15 months

• Waist Circumference

  Change in Waist Circumference

  Baseline to 9 months and sustained at 15 months

• Fasting Glucose

  Change in Fasting Glucose

  Baseline to 9 months and sustained at 15 months

• Hemoglobin A1c or HbA1c

  Change in Hemoglobin A1c or HbA1c

  Baseline to 9 months and sustained at 15 months

Secondary Outcomes (5)

• Diet/Nutrition - Plasma Carotenoid Levels

  Baseline to 9 months and sustained at 15 months

• Diet/Nutrition - Serum Lipid Levels

  Baseline to 9 months and sustained at 15 months

• Objective Measure of Physical Activity

  Baseline to 9 months and sustained at 15 months

• Smoking - Expired Breath Carbon Monoxide (CO) Levels

  Baseline to 9 months and sustained at 15 months

• Smoking - Change in Smoking through Recall

  Baseline to 9 months and sustained at 15 months

Study Arms (2)

Control Phase

NO INTERVENTION

3-month initial control phase (no intervention, month 1-3)

Intervention Phase

EXPERIMENTAL

6-month intervention phase - MIDAS Intervention Delivered. Followed by 6-month follow-up phase (no intervention, months 10-15).

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

Interventions

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

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.

Intervention Phase

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Residential Care Facilities (RCFs):
• 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:
• Age \>21 years
• Fluent in English
• Written informed consent to participate
• (1) Plans to leave the RCF during the next year.
• Resident Participants:
• Age 18 - 65 years
• Chart diagnosis of an SMI, mainly schizophrenia, schizoaffective disorder, or bipolar disorder
• Current treatment with antipsychotics
• Fluent in English

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego Division of Geriatric Psychiatry

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Obesity; Diabetes Mellitus; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Central Study Contacts

Dilip V Jeste, MD

CONTACT

(858) 534-4020; djeste@ucsd.edu

Danielle K Glorioso, LCSW

CONTACT

(858) 246-0767; dglorioso@ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The investigators will employ a modified cluster-randomized stepped wedge and adaptive trial design involving 210 residents with SMI and 120 staff members from 12 RCFs. The RCFs will be divided randomly into four cohorts of three RCFs each. Each cohort will be tested over a 15-month period that includes three phases: a three-month initial control phase (no intervention, from baseline month 0 to end of month 3), a six-month intervention phase (months 4 through 9), and a six-month follow-up phase (no intervention, months 10 through 15). All the study participants will be assessed quarterly during the 15-month period.

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: August 13, 2018
• Study Start: December 28, 2018
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)