Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness

The objective of this study is to perform a randomized clinical trial (IDEAL) to test a
comprehensive cardiovascular risk reduction program for persons with serious mental illness.
This trial will enroll adult mental health consumers with at least one cardiovascular risk
factor and randomize them to the 18-month IDEAL intervention or control. Intervention
participants will receive individual cardiovascular risk reduction counseling, coordination
with primary care providers to ensure appropriate management of risk factors, and
collaboration with mental health staff and social supports to encourage and motivate
participants to reach goals. All participants will be offered group exercise classes, and
programs will be provided with instruction to provide more healthy meals. The primary outcome
will be the change in estimated cardiovascular risk from the global Framingham Risk Score.

Inclusion Criteria:

- ▪ Age 18 and older

▪ Body mass index at least 25 kg/m2 OR one of the following CVD risk factors:

- Hypertension (SBP>= 140mmHg or DBP>= 90mmHg or on antihypertensive medications;

- Diabetes mellitus (fasting blood sugar> 125mg/dl or hemoglobin A1c>6.5 or on a
hypoglycemic medication);

- Dyslipidemia (LDL >130 mg/dl , HDL<40 or total cholesterol >=200 or on a lipid
lowering agent);

- Current tobacco smoker

- Able and willing to give informed consent

- Completion of baseline data collection

- Willing to accept randomization

- Willing to participate in the intervention

Exclusion Criteria:

- ▪ Cardiovascular event (unstable angina, myocardial infarction) within the past 6
months

- Serious medical condition which either limits life expectancy or requires active
management (e.g., certain cancers)

- Condition which interferes with outcome measurement (e.g., dialysis)

- Pregnant or planning a pregnancy during study period. Nursing mothers would need
approval from physician.

- Alcohol or substance use disorder if not sober/abstinent for 30 days

- Planning to leave rehabilitation center or clinic within 6 months or move out of
geographic area within 18 months

- Investigator judgment (e.g., for concerns about participant or staff safety)