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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lori Mosca, Columbia University
ClinicalTrials.gov Identifier:
NCT00728637
First received: August 4, 2008
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Behavioral: Family Passport to Heart Health Program
Behavioral: General Educational Materials

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of a Family Heart Health Intervention Trial (FIT Heart I)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Mean percent reduction in low-density lipoprotein (LDL) cholesterol levels in the special intervention group versus the control group [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean percent change in high density lipoprotein (HDL) cholesterol levels in the special intervention group versus the control group [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Attainment of the Therapeutic Lifestyle Change (TLC) diet [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Cost effectiveness of the personalized educational program to reduce LDL cholesterol levels and cost per life saved [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Impact of hsCRP beyond traditional risk factors on attainment of prevention goals [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Enrollment: 501
Study Start Date: January 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants took part in the Family Passport to Heart Health Program.
Behavioral: Family 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.
Active Comparator: 2
Participants took part in a control group.
Behavioral: General Educational Materials
Participants in the control group received an educational brochure about heart health at the baseline study visit.

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).

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728637

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Lori Mosca, MD, MPH, PhD Columbia University
  More Information

Publications:

Responsible Party: Lori Mosca, Professor of Medicine, Columbia University., Columbia University
ClinicalTrials.gov Identifier: NCT00728637     History of Changes
Other Study ID Numbers: AAAA5856, R01HL075101, R01 HL075101
Study First Received: August 4, 2008
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
Prevention

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on July 22, 2014