Family Heart Health Program: Randomized, Controlled Trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00552591

Acronym

FHHP-RCT

Enrollment

426

Registered

2007-11-02

Start date

2007-09-01

Completion date

2011-09-01

Last updated

2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

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

Brief 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).

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

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.

Design outcomes

Primary

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

Secondary

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