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

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ClinicalTrials.gov Identifier: NCT03627377
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Dilip V. Jeste, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Obesity Diabetes Lifestyle Risk Reduction Serious Mental Illness Behavioral: Multi-component Intervention for Diabetes in Adults with Serious Mental Illness Not Applicable

Detailed Description:
Serious mental illnesses (SMI), including schizophrenia, bipolar disorder, and schizoaffective disorder, are associated with increased medical comorbidity and premature mortality from diabetes and cardiovascular disease. Unhealthy lifestyles, including energy-dense (obesogenic) diet, sedentary behavior, and cigarette smoking are important risk factors for diabetes and accelerated biological aging. All of these risk factors are potentially modifiable. There is considerable literature documenting the effectiveness of strategies to prevent and manage diabetes in the general population; yet, these interventions are rarely offered to people with SMI. Residential Care Facilities (RCFs), called Board-and-Care Homes in California, are a common housing modality for patients with SMI; they provide a venue that can maximize efficiency and sustainability of a lifestyle intervention. The goals of the proposed four-year study are to tailor a multi-component intervention to this high-risk group. The study will be a hybrid effectiveness-implementation (Hybrid Type 1) trial of a Multi-component Intervention for Diabetes risk reduction in Adults with SMI (MIDAS) in licensed RCFs in San Diego county. As a Hybrid Type 1 study, the primary emphasis will be on determining the effectiveness of the intervention to achieve desired health outcomes while also systematically collecting data on its implementation within RCFs that will inform implementation strategy refinement. 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. 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. Our investigators will train RCF staff (especially the Activity Director and cook) to increase physical activity and reduce smoking, and to implement healthful dietary modifications among the residents, using evidence-based interventions. During the intervention phase, the RCF Activity Director will conduct twice-weekly manualized group sessions on education about diabetes, nutrition, exercise, and smoking cessation/reduction, to deliver a multi-component group intervention. We will also explore if there are improvements in blood-based research biomarkers of insulin resistance and inflammation in the RCF residents with SMI. This project is responsive to RFA-MH-17-608, and related to NIMH Strategic Objective #3.3B: testing interventions for effectiveness in community practice settings. If successful, MIDAS will be sustained and disseminated, and would lead to reduction in excess medical comorbidity and mortality associated with SMI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multi-component Intervention for Diabetes in Adults With Serious Mental Illness (MIDAS)
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

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).
Behavioral: 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 Measures :
  1. Body Mass Index (BMI in kg/m^2) [ Time Frame: Baseline to 9 months and sustained at 15 months ]
    Change in Body Mass Index

  2. Waist Circumference [ Time Frame: Baseline to 9 months and sustained at 15 months ]
    Change in Waist Circumference

  3. Fasting Glucose [ Time Frame: Baseline to 9 months and sustained at 15 months ]
    Change in Fasting Glucose

  4. Hemoglobin A1c or HbA1c [ Time Frame: Baseline to 9 months and sustained at 15 months ]
    Change in Hemoglobin A1c or HbA1c


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627377


Contacts
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Contact: Dilip V Jeste, MD (858) 534-4020 djeste@ucsd.edu
Contact: Danielle K Glorioso, LCSW (858) 246-0767 dglorioso@ucsd.edu

Locations
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United States, California
University of California, San Diego Division of Geriatric Psychiatry Recruiting
La Jolla, California, United States, 92093
Contact: Danielle K Glorioso, LCSW    858-246-0767    dglorioso@ucsd.edu   
Contact: Cynthia Ibarra, MA    (858) 822-6005    cyibarra@ucsd.edu   
Principal Investigator: Dilip V Jeste, MD         
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Dilip V. Jeste, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03627377    
Other Study ID Numbers: MH15127
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dilip V. Jeste, University of California, San Diego:
Schizophrenia
Serious mental illness
Obesity
Diabetes
Lifestyle Risk Reduction
Additional relevant MeSH terms:
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Diabetes Mellitus
Schizophrenia
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia Spectrum and Other Psychotic Disorders