N/A
N=269
Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness
Cardiovascular Risk Factors · Serious Mental Illness
Bottom Line
View on ClinicalTrials.gov: NCT02127671 ↗Enrolled (actual)
269
Serious AEs
23.8%
Results posted
Aug 2025
Primary outcome: Primary: Global Framingham Risk Score — 11.5; 12.7; 9.9; 12.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IDEAL intervention (Other); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Framingham Risk Score |
11.5; 12.7; 9.9; 12.3 | — |
| SECONDARY Weight in Pounds |
219.5; 208.6; 216.9; 208.3; 213.2; 202.9 | — |
| SECONDARY Body Mass Index (BMI) |
34.4; 32.9; 33.7; 32.1 | — |
| SECONDARY Distance Traveled in the 6 Minute Walk Test |
909.5; 910.7; 922.9; 926.9; 925.1; 910.7 | — |
| SECONDARY Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption |
8.8; 9.8; 8.4; 11.1; 9.1; 11.3 | — |
| SECONDARY Healthy Diet as Indicated by Fast Food Consumption |
4.3; 3.9; 3.7; 5.2; 3.8; 3.8 | — |
| SECONDARY Fasting Glucose Level |
106.5; 110.6; 106.7; 117.4 | — |
| SECONDARY Participants With Diabetes Mellitus Treated to Goal (HgBA1c) |
27; 25; 15; 26; 29; 23 | — |
| SECONDARY Current Smoking Status |
65; 73; 47; 67 | — |
| SECONDARY Blood Pressure |
118.0; 116.5; 75.3; 74.9; 120.1; 120.2 | — |
| SECONDARY Participants With Hypertension Treated to Goal |
61; 54; 11; 16; 62; 55 | — |
| SECONDARY Total Cholesterol |
178.9; 181.1; 171.8; 177.7 | — |
| SECONDARY LDL Cholesterol |
101.9; 101.0; 93.7; 97.3 | — |
| SECONDARY HDL Cholesterol |
49.2; 50.2; 50.7; 51.0 | — |
| SECONDARY Triglycerides |
140.2; 156.6; 141.0; 149.0 | — |
| SECONDARY Participants With Dyslipidemia Treated to Goal |
46; 53; 36; 40; 47; 55 | — |
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.
Eligibility Criteria
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 =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)
Data sourced from ClinicalTrials.gov (NCT02127671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.