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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effectiveness of a Family Heart Health Intervention Trial (FIT Heart I)

Conditions
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Cardiovascular Diseases, Heart Diseases

Intervention / Treatment
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* Behavioral: Family Passport to Heart Health Program
* Behavioral: General Educational Materials


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants took part in the Family Passport to Heart Health Program. | Behavioral: Family Passport to Heart Health Program<br>* 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.<br>|
| Active Comparator: 2<br>Participants took part in a control group. | Behavioral: General Educational Materials<br>* Participants in the control group received an educational brochure about heart health at the baseline study visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention