Evaluating the Effectiveness of a Family Heart Health Educational Program (The FIT-Heart Study)

Columbia University501 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

501

Conditions

Cardiovascular Diseases Heart Diseases

Interventions

Family Passport to Heart Health ProgramBEHAVIORAL

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.

General Educational MaterialsBEHAVIORAL

Participants in the control group received an educational brochure about heart health at the baseline study visit.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Mean percent reduction in low-density lipoprotein (LDL) cholesterol levels in the special intervention group versus the control group