Coronary Heart DiseaseFHHP-RCTNCT00552591

Family Heart Health Program: Randomized, Controlled Trial

A study testing 12-week risk reduction program, managed by a Heart Health Educator in people with Coronary Heart Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Coronary Heart Disease
What is being tested?: 12-week risk reduction program, managed by a Heart Health Educator
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 426 participants
Where: 1 siteCanada
Study dates: Sep 2007to Sep 2011
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 20 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Spouse, offspring or sibling of patient hospitalized at UOHI within the past 5 years for:
Acute coronary syndrome (ACS);
Elective percutaneous coronary intervention (PCI); or
Bypass surgery (CABG);
Willing to provide informed consent;
At least one of the following modifiable risk factors:

Show all 12Show fewer

Current smoker;
Systolic blood pressure ≥ 140 and or Diastolic BP ≥ 90 and/or currently on medication to treat high blood pressure;
Total cholesterol/HDL-cholesterol ratio ≥ 5.0 and/or on antilipemic medication;
Abdominal obesity (for men, waist circumference > 102 cm; for women, waist circumference > 88cm);
Physical Inactivity [<150 min mod, 5-7 d/week or <100 min vig, 4-7 d/week]
Geographically available for assessment, intervention and follow-up.

Who cannot join

Unable to understand English or French;
History of diabetes mellitus or any atherosclerotic disease;
Fasting glucose ≥ 7.0 mmol/L at screening;
Presence of life threatening illness (e.g., known or suspected cancer or other disease with a life expectancy of less than five years);
Chronic kidney disease and/or undergoing dialysis;
Active liver disease;

Show all 9Show fewer

Pregnant or planning to become pregnant within the next year;
Cognitive impairment;
Other family member already participating in study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7

Other trials in Canada

About this study

Background: Family members (spouses, siblings, offspring) of patients with coronary heart disease (CHD) may themselves be at increased risk for developing CHD for genetic, biochemical and/or behavioural reasons. Targeted approaches aimed at family members of those with established CHD may be a cost-effective way to identify high-risk persons and link them to effective risk factor modification. During pilot testing we found 29% of family members of patients recently hospitalized at our institution had ≥ 3 CHD risk factors. Encouragingly, they indicated high levels of "readiness" to change underlying risk behaviours such as cigarette smoking and physical inactivity. We have developed a 12-week family heart health program featuring a personal plan for achieving risk factor goals and weekly contact with a heart health educator. This intervention needs to be fully tested.

Research Aims:

In this study, we will:

Compare the effects of a targeted family heart health (FHH) screening, counselling and follow-up program versus usual care (UC) for reducing participants total cholesterol/high density lipoprotein (TC/HDL) ratio 52 weeks after program entry, in family members of patients recently hospitalized with CHD;
Compare the effects of the FHH program versus UC on modifiable components comprising the Framingham score, including: smoking status; systolic blood pressure; total cholesterol; and high density lipoprotein cholesterol;
Compare the effects of the FHH program versus UC on: lifestyle-related factors (dietary patterns, leisure time exercise, body composition); medication use (anti-lipemic medications, anti-hypertensive medications, pharmacotherapies for smoking cessation); and use of healthcare resources (physician visits, hospitalization days, number of laboratory and diagnostic tests and procedures).

Conditions: Coronary Heart Disease
Being tested: 12-week risk reduction program, managed by a Heart Health Educator
Keywords: family risk, behavior modification, lifestyle change, prevention of CHD, health care costs
Medical subject headings: Coronary Disease

What participants receive

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

12-week risk reduction program, managed by a Heart Health EducatorBehavioural
The educator and participant will negotiate a personal plan for achieving the goals through lifestyle change (i.e. smoking cessation, increased exercise, improved nutrition) and, if necessary, pharmacotherapy coordinated by the participant's personal physician. Educational modules have been developed to address specific lifestyle issues including smoking cessation, healthy eating, exercise, and weight management, and will be provided to participants as required. A summary of the risk factor profile and personal plan will be incorporated into a report for the participant's personal physician as well. Participants will also receive telephone-based motivational counseling sessions for 12 weeks to address specific lifestyle issues.

Study groups in NCT00552591
Study group	Role	What they receive
1	Experimental	Family Heart Health Program Receives: Behavioral: 12-week risk reduction program, managed by a Heart Health Educator
2	No intervention	Usual Care

What is being measured

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

Ratio of Total Cholesterol to HDL Cholesterol TC/HDL
Measured: Baseline to one year
Physical Activity
Measured: Baseline to 1 year
Servings of Fruits and Vegetables
Measured: Baseline to 1 year

Secondary outcomes (5)

Cholesterol Levels
Measured: Baseline to 1 year
Glucose Levels
Measured: Baseline to 1 year
Blood Pressure
Measured: Baseline to 1 year
Body Mass Index
Measured: Baseline to 1 year
Waist Circumference
Measured: Baseline to 1 year

Timeline

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

Sep 2007Sep 2011

First posted2 Nov 2007 (estimated)
Study startSep 2007
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: None (open label)
Enrolment: 426 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00552591
Sponsor's protocol ID: NA 6142
Acronym: FHHP-RCT
Status last verified: Feb 2022
First submitted: 1 Nov 2007
Last updated: 30 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Reid RD, McDonnell LA, Riley DL, Mark AE, Mosca L, Beaton L, Papadakis S, Blanchard CM, Mochari-Greenberger H, O'Farrell P, Wells GA, Slovinec D'Angelo ME, Pipe AL. Effect of an intervention to improve the cardiovascular health of family members of patients with coronary artery disease: a randomized trial. CMAJ. 2014 Jan 7;186(1):23-30. doi: 10.1503/cmaj.130550. Epub 2013 Nov 18.
PubMed 24246588

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome

All Coronary Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Family Heart Health Program: Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT00552591
Acronym / sponsor ID: FHHP-RCT / NA 6142
Conditions: Coronary Heart Disease
Keywords: family risk, behavior modification, lifestyle change, prevention of CHD, health care costs
Study type: Interventional
Recruitment status: Completed
Enrolment: 426 participants (actual)
Lead sponsor: Ottawa Heart Institute Research CorporationUniversity, hospital or other
Collaborators: Heart and Stroke Foundation of Canada
Study start: Sep 2007
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 2 Nov 2007 (estimated)
Results: Posted 30 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Research Aims:

In this study, we will:

Compare the effects of a targeted family heart health (FHH) screening, counselling and follow-up program versus usual care (UC) for reducing participants total cholesterol/high density lipoprotein (TC/HDL) ratio 52 weeks after program entry, in family members of patients recently hospitalized with CHD;
Compare the effects of the FHH program versus UC on modifiable components comprising the Framingham score, including: smoking status; systolic blood pressure; total cholesterol; and high density lipoprotein cholesterol;
Compare the effects of the FHH program versus UC on: lifestyle-related factors (dietary patterns, leisure time exercise, body composition); medication use (anti-lipemic medications, anti-hypertensive medications, pharmacotherapies for smoking cessation); and use of healthcare resources (physician visits, hospitalization days, number of laboratory and diagnostic tests and procedures).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Behavioral: 12-week risk reduction program, managed by a Heart Health EducatorFamily Heart Health Program
2	No intervention	–Usual Care

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Spouse, offspring or sibling of patient hospitalized at UOHI within the past 5 years for:
Willing to provide informed consent;
At least one of the following modifiable risk factors:
Geographically available for assessment, intervention and follow-up.

Key exclusion criteria (9 listed)

Unable to understand English or French;
History of diabetes mellitus or any atherosclerotic disease;
Fasting glucose ≥ 7.0 mmol/L at screening;
Presence of life threatening illness (e.g., known or suspected cancer or other disease with a life expectancy of less than five years);
Chronic kidney disease and/or undergoing dialysis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
12-week risk reduction program, managed by a Heart Health EducatorThe educator and participant will negotiate a personal plan for achieving the goals through lifestyle change (i.e. smoking cessation, increased exercise, improved nutrition) and, if necessary, pharmacotherapy coordinated by the participant's personal physician. Educational modules have been developed to address specific lifestyle issues including smoking cessation, healthy eating, exercise, and weight management, and will be provided to participants as required. A summary of the risk factor profile and personal plan will be incorporated into a report for the participant's personal physician as well. Participants will also receive telephone-based motivational counseling sessions for 12 weeks to address specific lifestyle issues.	Behavioural	1

Primary outcome

Ratio of Total Cholesterol to HDL Cholesterol TC/HDL
Time frame: Baseline to one year
Physical Activity
Time frame: Baseline to 1 year
Servings of Fruits and Vegetables
Time frame: Baseline to 1 year

5 secondary outcomes

Cholesterol Levels
Time frame: Baseline to 1 year
Glucose Levels
Time frame: Baseline to 1 year
Blood Pressure
Time frame: Baseline to 1 year
Body Mass Index
Time frame: Baseline to 1 year
Waist Circumference
Time frame: Baseline to 1 year

Results and safety

Results posted to the registry on 30 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Family Heart-Health Intervention	211	159
Control Group	215	157

Primary outcome: Ratio of Total Cholesterol to HDL Cholesterol TC/HDL

Time frame: Baseline to one year. Mean (Standard Deviation). Unit: Ratio

Measure	Family Heart-Health Intervention n = 211	Control Group n = 215
Baseline	4.12 (1.29)	4.22 (1.26)
at 3 months	4.02 (1.25)	4.02 (1.18)
at 12months	4.06 (1.31)	3.96 (1.09)

Primary outcome: Physical Activity

Time frame: Baseline to 1 year. Mean (Standard Deviation). Unit: minutes/week

Measure	Family Heart-Health Intervention n = 211	Control Group n = 215
Baseline	91.7 (102.5)	88.7 (99.7)
at 3months	176.4 (110.9)	110.6 (115.3)
at 12months	142.5 (122)	118.6 (109.1)

Primary outcome: Servings of Fruits and Vegetables

Time frame: Baseline to 1 year. Mean (Standard Deviation). Unit: Servings per day

Measure	Family Heart-Health Intervention n = 211	Control Group n = 215
Baseline	6.3 (3.0)	6.5 (3.1)
at 3 months	8.0 (3.3)	6.8 (3.2)
at 12 months	7.4 (3.4)	6.6 (3.0)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Family Heart-Health Intervention	0 of 211 (0%)	0 of 211 (0%)	0 of 211
Control Group	0 of 215 (0%)	0 of 215 (0%)	0 of 215

Limitations and caveats (from the sponsor): * a small proportion of people at medium or high risk of CAD were recruited * those with known diabetes or established cardiovascular disease were excluded as they were likely receiving medical care * The participants were primarily well-educated white people who lived in urban areas. * Participants who volunteer for trials may be more motivated than those who do not.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24246588Reid RD, McDonnell LA, Riley DL, Mark AE, Mosca L, Beaton L, Papadakis S, Blanchard CM, Mochari-Greenberger H, O'Farrell P, Wells GA, Slovinec D'Angelo ME, Pipe AL. Effect of an intervention to improve the cardiovascular health of family members of patients with coronary artery disease: a randomized trial. CMAJ. 2014 Jan 7;186(1):23-30. doi: 10.1503/cmaj.130550. Epub 2013 Nov 18.

Related trials for Coronary Heart Disease

Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert D Reid, MBA, PhD principal investigator

Ottawa Heart Institute Research Corporation

Andrew L Pipe, MD study chair

Ottawa Heart Institute Research Corporation

Lori J Mosca, MD, PhD study chair

New York Presbyterian Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 12-week risk reduction program, managed by a Heart Health Educator in people with Coronary Heart Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

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 12 inclusion and 9 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 30 Jun 2026. 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 Canada. 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 30 Jun 2026). 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?

Ratio of Total Cholesterol to HDL Cholesterol TC/HDL (time frame: Baseline to one year). The study lists 3 primary outcomes in all. 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 NCT00552591, 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 30 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.