Skip to main content
OpenTrials
Completed

NCT Number: NCT00552591

Family Heart Health Program: Randomized, Controlled Trial

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:
  • 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.

Exclusion criteria

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

Treatment and study plan

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

Behavioral

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.

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

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Acronym: FHHP-RCT

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Nov 2, 2007
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.