This study will determine whether a program where a health coach works with participants on heart healthy behaviors and treatment of risk factors is coordinated with primary care can reduce overall heart disease risk in people 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
269
Johns Hopkins ProHealth Clinical Research Facility
Woodlawn, Maryland, United States
Global Framingham Risk Score
Global Framingham Cardiovascular disease Risk Score. Higher score indicates higher cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke
Time frame: Baseline, 18 months
Weight in Pounds
Weight measured in pounds.
Time frame: Baseline, 6 and 18 months
Body Mass Index (BMI)
Body mass index measured in kg/meter2
Time frame: baseline and 18 months
Distance Traveled in the 6 Minute Walk Test
6 minute walk test measured in feet. More feet traveled indicates better results.
Time frame: Baseline, 6 and 18 months
Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption
Self reported number of sugar sweetened beverages consumed per week on average. A higher score indicated a greater number of sugar sweetened beverages consumed.
Time frame: Baseline, 6 and 18 months
Healthy Diet as Indicated by Fast Food Consumption
Self reported number of times eating at a fast food restaurant per month on average. A higher score indicates a greater frequency of eating fast food.
Time frame: baseline, 6 and 18 months
Fasting Glucose Level
Fasting glucose level reported in mg/dl.
Time frame: baseline and 18 months
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Participants With Diabetes Mellitus Treated to Goal (HgBA1c)
A1c Goal used for analysis was \<7.
Time frame: Baseline, 6 and 18 months
Current Smoking Status
Self reported smoking status for clients with the data below reflecting the number of clients who reported currently smoking at that time point.
Time frame: Baseline and 18 months
Blood Pressure
Systolic and diastolic blood pressure measured in mmhg
Time frame: baseline and 18 months
Participants With Hypertension Treated to Goal
Hypertension goal used for analysis was systolic blood pressure \<140 and diastolic blood pressure \<90. not modeled
Time frame: Baseline, 6 and 18 months
Total Cholesterol
Total cholesterol measured in mg/dl
Time frame: Baseline and 18 months
LDL Cholesterol
LDL cholesterol measured in mg/dl
Time frame: Baseline and 18 months
HDL Cholesterol
HDL cholesterol measured in mg/dl
Time frame: Baseline and 18 months
Triglycerides
Triglycerides measured in mg/dl
Time frame: Baseline and 18 months
Participants With Dyslipidemia Treated to Goal
Goal used for analysis was LDL cholesterol \< 130 mg/dl and Total cholesterol \< 200mg/dl.
Time frame: Baseline, 6 and 18 months