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CompletedNCT00552591FHHP-RCTUpdated Jun 30, 2026Results posted

Family Heart Health Program: Randomized, Controlled Trial

An interventional study of 12-week risk reduction program, managed by a Heart Health Educator in Coronary Heart Disease, sponsored by Ottawa Heart Institute Research Corporation. Completed at 1 site in Canada. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
426
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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:

  1. 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;
  2. 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;
  3. 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).
02

Conditions studied

  • Coronary Heart Disease

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Keywords

  • family risk
  • behavior modification
  • lifestyle change
  • prevention of CHD
  • health care costs
03

In context

Coronary Disease

2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.

This study's enrollment of 426 is above the median of 124 across 1,583 interventional studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

Ottawa Heart Institute Research Corporation is the lead sponsor of 179 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Spouse, offspring or sibling of patient hospitalized at UOHI within the past 5 years for:

    1. Acute coronary syndrome (ACS);
    2. Elective percutaneous coronary intervention (PCI); or
    3. Bypass surgery (CABG);
  • Willing to provide informed consent;

  • At least one of the following modifiable risk factors:

    1. Current smoker;
    2. Systolic blood pressure ≥ 140 and or Diastolic BP ≥ 90 and/or currently on medication to treat high blood pressure;
    3. Total cholesterol/HDL-cholesterol ratio ≥ 5.0 and/or on antilipemic medication;
    4. Abdominal obesity (for men, waist circumference > 102 cm; for women, waist circumference > 88cm);
    5. 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.

Exclusion criteria

Exclusion Criteria:

  1. Unable to understand English or French;
  2. History of diabetes mellitus or any atherosclerotic disease;
  3. Fasting glucose ≥ 7.0 mmol/L at screening;
  4. Presence of life threatening illness (e.g., known or suspected cancer or other disease with a life expectancy of less than five years);
  5. Chronic kidney disease and/or undergoing dialysis;
  6. Active liver disease;
  7. Pregnant or planning to become pregnant within the next year;
  8. Cognitive impairment;
  9. Other family member already participating in study.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
426 participants (actual)

Study arms

  • Experimental
    1

    Family Heart Health Program

    Behavioral: 12-week risk reduction program, managed by a Heart Health Educator

  • No intervention
    2

    Usual Care

Interventions

  • Behavioral12-week risk reduction program, managed by a Heart Health Educator

    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.

06

What researchers measure

Primary outcomes

  1. Ratio of Total Cholesterol to HDL Cholesterol TC/HDL

    Time frame: Baseline to one year

  2. Physical Activity

    Time frame: Baseline to 1 year

  3. Servings of Fruits and Vegetables

    Time frame: Baseline to 1 year

Secondary outcomes

  1. Cholesterol Levels

    Time frame: Baseline to 1 year

  2. Glucose Levels

    Time frame: Baseline to 1 year

  3. Blood Pressure

    Time frame: Baseline to 1 year

  4. Body Mass Index

    Time frame: Baseline to 1 year

  5. Waist Circumference

    Time frame: Baseline to 1 year

07

Results

Posted Jun 30, 2026
Limitations and caveats
* 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.

Participant flow

Participant flow — Overall Study
MilestoneFamily Heart-Health InterventionControl Group
Started211215
Completed159157
Not completed5258
Withdrew: Lost to follow-up5258

Outcome measures

PrimaryRatio of Total Cholesterol to HDL Cholesterol TC/HDL
Time frame:
Baseline to one year
Reported as:
Mean · Ratio
Ratio of Total Cholesterol to HDL Cholesterol TC/HDL
RatioFamily Heart-Health InterventionControl Group
Baseline4.12 ± 1.294.22 ± 1.26
at 3 months4.02 ± 1.254.02 ± 1.18
at 12months4.06 ± 1.313.96 ± 1.09
PrimaryPhysical Activity
Time frame:
Baseline to 1 year
Reported as:
Mean · minutes/week
Physical Activity
minutes/weekFamily Heart-Health InterventionControl Group
Baseline91.7 ± 102.588.7 ± 99.7
at 3months176.4 ± 110.9110.6 ± 115.3
at 12months142.5 ± 122118.6 ± 109.1
PrimaryServings of Fruits and Vegetables
Time frame:
Baseline to 1 year
Reported as:
Mean · Servings per day
Servings of Fruits and Vegetables
Servings per dayFamily Heart-Health InterventionControl Group
Baseline6.3 ± 3.06.5 ± 3.1
at 3 months8.0 ± 3.36.8 ± 3.2
at 12 months7.4 ± 3.46.6 ± 3.0
SecondaryCholesterol Levels
Time frame:
Baseline to 1 year
Reported as:
Mean · mmol/L
Cholesterol Levels
mmol/LFamily Heart-Health InterventionControl Group
Baseline - Total cholesterol5.13 ± 0.975.18 ± 1.02
3month - Total Cholesterol4.99 ± 0.964.95 ± 1.00
12month - Total Cholesterol5.03 ± 0.984.93 ± 1.01
Baseline - HDL Cholesterol1.33 ± 0.381.30 ± 0.34
3month - HDL cholesterol1.34 ± 0.391.30 ± 0.34
12month - HDL cholesterol1.34 ± 0.411.29 ± 0.30
Baseline - LDL cholesterol3.22 ± 0.863.28 ± 0.91
3months - LDL cholesterol3.10 ± 0.823.09 ± 0.90
12months - LDL cholesterol3.11 ± 0.823.04 ± 0.92
Baseline - Triglycerides1.28 ± 0.771.35 ± 0.84
3months - Triglycerides1.22 ± 0.661.24 ± 0.57
12month - Triglycerides1.35 ± 0.801.34 ± 0.64
SecondaryGlucose Levels
Time frame:
Baseline to 1 year
Reported as:
Mean · mmol/L
Glucose Levels
mmol/LFamily Heart-Health InterventionControl Group
Baseline - Glucose5.12 ± 0.525.09 ± 0.59
at 3 months5.12 ± 0.505.18 ± 0.54
at 12 months5.16 ± 0.605.13 ± 0.57
SecondaryBlood Pressure
Time frame:
Baseline to 1 year
Reported as:
Mean · mmHg
Blood Pressure
mmHgFamily Heart-Health InterventionControl Group
Baseline - Systolic121.8 ± 15.3120.4 ± 16.9
Baseline - Diastolic76.8 ± 9.076.3 ± 9.9
3 months - Systolic116.4 ± 14.8115.8 ± 14.8
3 months - Diastolic73.8 ± 8.374.2 ± 9.5
12 months - Systolic118.5 ± 14.3117.5 ± 14.7
12 months - Diastolic75.5 ± 9.574.8 ± 8.7
SecondaryBody Mass Index
Time frame:
Baseline to 1 year
Reported as:
Mean · kg/m2
Body Mass Index
kg/m2Family Heart-Health InterventionControl Group
Baseline29.2 ± 5.429.6 ± 6.0
3 months28.2 ± 4.829.4 ± 5.9
12 months27.9 ± 4.829.0 ± 5.3
SecondaryWaist Circumference
Time frame:
Baseline to 1 year
Reported as:
Mean · centimeters
Waist Circumference
centimetersFamily Heart-Health InterventionControl Group
Baseline96.3 ± 13.597.4 ± 15.1
at 3 months93.7 ± 13.796.2 ± 14.7
at 12 months92.5 ± 13.495.1 ± 13.8

Adverse events

Collected over Baseline to 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Family Heart-Health Intervention0/211 (0%)0/211 (0%)0/211 (0%)
Control Group0/215 (0%)0/215 (0%)0/215 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Family Heart-Health InterventionControl GroupTotal
Mean52.0 ± 11.951.1 ± 11.351.5 ± 11.6
Sex: Female, Male
Sex: Female, Male(Participants)Family Heart-Health InterventionControl GroupTotal
Female128133261
Male8382165
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Family Heart-Health InterventionControl GroupTotal
White201205406
Married or living with partner
Married or living with partner(Participants)Family Heart-Health InterventionControl GroupTotal
Count of participants164172336
Education
Education(years)Family Heart-Health InterventionControl GroupTotal
Mean14.6 ± 2.614.7 ± 2.614.7 ± 2.6
Family history of premature CAD
Family history of premature CAD(Participants)Family Heart-Health InterventionControl GroupTotal
Count of participants9695191
Current daily smoker
Current daily smoker(Participants)Family Heart-Health InterventionControl GroupTotal
Count of participants201939
No family doctor
No family doctor(Participants)Family Heart-Health InterventionControl GroupTotal
Count of participants91423

7 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of Ottawa Heart Institute
    Ottawa, Ontario K1Y 4W7, Canada
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00552591
Lead sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Heart and Stroke Foundation of Canada
Responsible party
Sponsor
First posted
Nov 2, 2007
Start date
Sep 2007
Primary completion
Sep 2011
Completion
Sep 2011
Results posted
Jun 30, 2026
Last update
Jun 30, 2026

Study contacts

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
Heidi Mochari, MPH, RD
study chair · New York Presbyterian Hospital
George Wells, PhD
study chair · Ottawa Heart Institute Research Corporation
Louise J Beaton, MSc
study chair · Ottawa Heart Institute Research Corporation
Pat O'Farrell, RN
study chair · Ottawa Heart Institute Research Corporation
Chris M Blanchard, PhD
study chair · Dalhousie University
Sophia Papadakis, MHA
study chair · Ottawa Heart Institute Research Corporation
Monika Slovinec D'Angelo, PhD
study chair · Ottawa Heart Institute Research Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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