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

NCT02127671 | Completed Results DMC

• 2 other identifiers: NA_00072197R01HL112299
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factors; Serious Mental Illness

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 18 months

Secondary Outcomes (15)

• Weight in Pounds

  Baseline, 6 and 18 months

• Body Mass Index (BMI)

  baseline and 18 months

• Distance Traveled in the 6 Minute Walk Test

  Baseline, 6 and 18 months

• Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption

  Baseline, 6 and 18 months

• Healthy Diet as Indicated by Fast Food Consumption

  baseline, 6 and 18 months

Other Outcomes (4)

• Health Status With Short Form (SF)-12

  Baseline, 6 and 18 months

• Quality of Life Based on the EUROQOL

  Baseline, 6 and 18 months

• Medication Adherence

  Baseline, 6 and 18 months

Study Arms (2)

IDEAL intervention

EXPERIMENTAL

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. All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.

Other: IDEAL intervention

Control

OTHER

All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.

Other: Control

Interventions

IDEAL intervention OTHER

IDEAL intervention

Control OTHER

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ▪ 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

You may not qualify if:

• ▪ 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins ProHealth Clinical Research Facility

Woodlawn, Maryland, United States

Location

Related Publications (1)

• Daumit GL, Dalcin AT, Dickerson FB, Miller ER, Evins AE, Cather C, Jerome GJ, Young DR, Charleston JB, Gennusa JV 3rd, Goldsholl S, Cook C, Heller A, McGinty EE, Crum RM, Appel LJ, Wang NY. Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e207247. doi: 10.1001/jamanetworkopen.2020.7247.

  PMID: 32530472 DERIVED

Results Point of Contact

• Title: Gail Daumit, MD, MHS
• Organization: Johns Hopkins University School of Medicine

gdaumit@jhmi.edu

410-614-6460

Study Officials

• Gail L. Daumit, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: December 12, 2013
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-07

Locations

US (1)