Evaluating the Effectiveness of a Family Heart Health Educational Program (The FIT-Heart Study)
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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).
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
501 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal