Evaluating the Effectiveness of a Family Heart Health Educational Program (The FIT-Heart Study) (FIT-Heart)
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|ClinicalTrials.gov Identifier: NCT00728637|
Recruitment Status : Completed
First Posted : August 6, 2008
Last Update Posted : May 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases||Behavioral: Family Passport to Heart Health Program Behavioral: General Educational Materials||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||501 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness of a Family Heart Health Intervention Trial (FIT Heart I)|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
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.
- 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 ]
- 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 ]
- Attainment of the Therapeutic Lifestyle Change (TLC) diet [ Time Frame: 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 [ Time Frame: Measured at Year 1 ]
- Cost effectiveness of the personalized educational program to reduce LDL cholesterol levels and cost per life saved [ Time Frame: Measured at Year 1 ]
- Impact of hsCRP beyond traditional risk factors on attainment of prevention goals [ Time Frame: Measured at Year 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728637
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Lori Mosca, MD, MPH, PhD||Columbia University|