Diabetes, Lifestyle Risk Reduction, Obesity, Schizophrenia, Serious Mental Illness
Conditions
Keywords
Schizophrenia, Serious mental illness, Obesity, Diabetes, Lifestyle Risk Reduction
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.
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.
Interventions
BEHAVIORALMulti-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.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI in kg/m^2) | Baseline to 9 months and sustained at 15 months | Change in Body Mass Index |
| Waist Circumference | Baseline to 9 months and sustained at 15 months | Change in Waist Circumference |
| Fasting Glucose | Baseline to 9 months and sustained at 15 months | Change in Fasting Glucose |
| Hemoglobin A1c or HbA1c | Baseline to 9 months and sustained at 15 months | Change in Hemoglobin A1c or HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diet/Nutrition - Plasma Carotenoid Levels | 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 |
| Smoking - Change in Smoking through Recall | 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. |
| Diet/Nutrition - Serum Lipid Levels | Baseline to 9 months and sustained at 15 months | Plasma Carotenoid levels reflect changing dietary vegetable and fruit intake. |
| Objective Measure of Physical Activity | 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. |
| Smoking - Expired Breath Carbon Monoxide (CO) Levels | 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. |
Countries
United States
Contacts
Primary ContactDilip V Jeste, MD
Backup ContactDanielle K Glorioso, LCSW
Outcome results
None listed