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

Not Applicable

Completed

• Conditions: Serious Mental Illness; Cardiovascular Risk Factors

• Registration Number: NCT02127671
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-12-12
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-01
• Primary Completion: 2018-11-16
• Study Completion: 2018-11-16
• Status Verified: 2025-07
• Results First Submitted: 2025-07-03
• Results First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Results First Posted: 2025-08-11
• Last Update Posted: 2025-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global Framingham Risk Score	Baseline, 18 months	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

Secondary Outcome Measures

Name	Time	Method
Weight in Pounds	Baseline, 6 and 18 months	Weight measured in pounds.
Body Mass Index (BMI)	baseline and 18 months	Body mass index measured in kg/meter2
Distance Traveled in the 6 Minute Walk Test	Baseline, 6 and 18 months	6 minute walk test measured in feet. More feet traveled indicates better results.
Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption	Baseline, 6 and 18 months	Self reported number of sugar sweetened beverages consumed per week on average. A higher score indicated a greater number of sugar sweetened beverages consumed.
Healthy Diet as Indicated by Fast Food Consumption	baseline, 6 and 18 months	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.
Fasting Glucose Level	baseline and 18 months	Fasting glucose level reported in mg/dl.
Participants With Diabetes Mellitus Treated to Goal (HgBA1c)	Baseline, 6 and 18 months	A1c Goal used for analysis was \<7.
Current Smoking Status	Baseline and 18 months	Self reported smoking status for clients with the data below reflecting the number of clients who reported currently smoking at that time point.
Blood Pressure	baseline and 18 months	Systolic and diastolic blood pressure measured in mmhg
Participants With Hypertension Treated to Goal	Baseline, 6 and 18 months	Hypertension goal used for analysis was systolic blood pressure \<140 and diastolic blood pressure \<90. not modeled
Total Cholesterol	Baseline and 18 months	Total cholesterol measured in mg/dl
LDL Cholesterol	Baseline and 18 months	LDL cholesterol measured in mg/dl
HDL Cholesterol	Baseline and 18 months	HDL cholesterol measured in mg/dl
Triglycerides	Baseline and 18 months	Triglycerides measured in mg/dl
Participants With Dyslipidemia Treated to Goal	Baseline, 6 and 18 months	Goal used for analysis was LDL cholesterol \< 130 mg/dl and Total cholesterol \< 200mg/dl.

Trial Locations

Locations (1)

Johns Hopkins ProHealth Clinical Research Facility; 🇺🇸 Woodlawn, Maryland, United States