Cardiovascular Diseases, Heart Diseases
Conditions
Keywords
Prevention
Brief summary
The primary objective of the FIT Heart Study was to test the effectiveness of a hospital-based standardized screening and educational intervention targeted to family members of patients hospitalized with CVD, to increase adherence to CVD prevention guidelines.
Detailed description
FIT Heart was a randomized controlled trial that tested a novel systems approach to increase adherence to national prevention guidelines among family members of patients hospitalized with CVD. Participants were blood relatives or cohabitants of patients hospitalized with atherosclerotic cardiovascular disease, aged 20-79 years, did not have established cardiovascular disease or diabetes, and spoke English or Spanish. Participants randomized to a special intervention group received behavioral counseling and education on diet and physical activity; personalized risk factor screening and immediate feedback; and reinforcement and follow-up throughout the year. The control group received a brief CVD prevention message in the form of a handout. All participants received standardized assessments of diet, lifestyle, and CVD risk factors at baseline and 1 year (94% follow-up). The main findings have been published showing the mean percent change in LDL-cholesterol level from baseline to 1-year improved in both groups and was not significantly different in the special intervention vs. control group (-1% vs. -2%; p=.64).
Interventions
BEHAVIORALFamily Passport to Heart Health Program
Participants in this group received personalized heart disease risk factor screening at the baseline study visit. They were taught lifestyle approaches to risk reduction based upon national heart disease prevention guidelines, including the Adult Treatment Panel (ATP) III recommendations for improving blood cholesterol levels with a TLC diet. Participants had regular contact with study staff and will receive individualized feedback throughout the study.
BEHAVIORALGeneral Educational Materials
Participants in the control group received an educational brochure about heart health at the baseline study visit.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Life expectancy of at least 5 years after study entry * Willing to return at Year 1 for a repeat study evaluation * Family member was hospitalized with acute atherosclerotic cardiovascular disease, including catheter-based procedures and coronary artery bypass grafting * Speaks either English or Spanish
Exclusion criteria
* Established cardiovascular disease, diabetes, active liver disease, or long-term kidney disease * Life expectancy less than 5 years from study entry * Prescription of a special diet that is not compatible with the TLC diet * Participation in a clinical drug study in the 3 months before study entry * Pregnant or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent reduction in low-density lipoprotein (LDL) cholesterol levels in the special intervention group versus the control group | Measured at Year 1 |
Secondary
| Measure | Time frame |
|---|---|
| Mean percent change in high density lipoprotein (HDL) cholesterol levels in the special intervention group versus the control group | Measured at Year 1 |
| Attainment of the Therapeutic Lifestyle Change (TLC) diet | Measured at Year 1 |
| Change in lipoproteins, high sensitivity C-reactive protein (hsCRP), blood pressure, body mass index, waist circumference, Framingham risk, and diet score in the special intervention group versus the control group | Measured at Year 1 |
| Cost effectiveness of the personalized educational program to reduce LDL cholesterol levels and cost per life saved | Measured at Year 1 |
| Impact of hsCRP beyond traditional risk factors on attainment of prevention goals | Measured at Year 1 |
Countries
United States
Outcome results
None listed