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Cardiovascular Risk FactorsIDEALNCT02127671

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

A study testing IDEAL intervention in people with Cardiovascular Risk Factors and Serious Mental Illness, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IDEAL intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
1 siteUnited States
Study dates
12 Dec 2013to 16 Nov 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ▪ 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
Show all 10Show fewer
  • Able and willing to give informed consent
  • Completion of baseline data collection
  • Willing to accept randomization
  • Willing to participate in the intervention

Who cannot join

  • ▪ 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins ProHealth Clinical Research Facility

    Woodlawn, Maryland

Other trials in United States

About this study

Official title: Comprehensive Cardiovascular Diseases (CVD) Risk Reduction Trial in Persons With Serious Mental Illness

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.

Read the 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.

Being tested
IDEAL intervention, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDEAL interventionOther

  • ControlOther

Study groups in NCT02127671
Study groupRoleWhat they receive
IDEAL interventionExperimentalIndividual 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.
Receives: Other: IDEAL intervention
ControlOtherAll participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, 18 months

Secondary outcomes (15)

  1. Weight in Pounds

    Weight measured in pounds.

    Measured: Baseline, 6 and 18 months

  2. Body Mass Index (BMI)

    Body mass index measured in kg/meter2

    Measured: baseline and 18 months

  3. Distance Traveled in the 6 Minute Walk Test

    6 minute walk test measured in feet. More feet traveled indicates better results.

    Measured: Baseline, 6 and 18 months

  4. 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.

    Measured: Baseline, 6 and 18 months

  5. 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.

    Measured: baseline, 6 and 18 months

  6. Fasting Glucose Level

    Fasting glucose level reported in mg/dl.

    Measured: baseline and 18 months

  7. Participants With Diabetes Mellitus Treated to Goal (HgBA1c)

    A1c Goal used for analysis was <7.

    Measured: Baseline, 6 and 18 months

  8. 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.

    Measured: Baseline and 18 months

  9. Blood Pressure

    Systolic and diastolic blood pressure measured in mmhg

    Measured: baseline and 18 months

  10. Participants With Hypertension Treated to Goal

    Hypertension goal used for analysis was systolic blood pressure <140 and diastolic blood pressure <90. not modeled

    Measured: Baseline, 6 and 18 months

  11. Total Cholesterol

    Total cholesterol measured in mg/dl

    Measured: Baseline and 18 months

  12. LDL Cholesterol

    LDL cholesterol measured in mg/dl

    Measured: Baseline and 18 months

  13. HDL Cholesterol

    HDL cholesterol measured in mg/dl

    Measured: Baseline and 18 months

  14. Triglycerides

    Triglycerides measured in mg/dl

    Measured: Baseline and 18 months

  15. Participants With Dyslipidemia Treated to Goal

    Goal used for analysis was LDL cholesterol < 130 mg/dl and Total cholesterol < 200mg/dl.

    Measured: Baseline, 6 and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2014 (estimated)
  2. Study start12 Dec 2013
  3. Primary completion16 Nov 2018
  4. Study completion16 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02127671
Sponsor's protocol ID
NA_00072197
Other IDs
R01HL112299
Acronym
IDEAL
Status last verified
Jul 2025
First submitted
29 Apr 2014
Last updated
11 Aug 2025
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32530472

Questions about this trial

What is this clinical trial studying?

A study testing IDEAL intervention in people with Cardiovascular Risk Factors and Serious Mental Illness, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Framingham Risk Score (time frame: Baseline, 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02127671, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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