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

Cardiovascular Diseases Clinical Trial

— FIT-Heart  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728637
• Other study ID #: AAAA5856
• Secondary ID: R01HL075101
• Status: Completed
• Phase: N/A
• First received: August 4, 2008
• Last updated: May 14, 2013
• Start date: January 2005
• Est. completion date: June 2008

Study information

• Verified date: May 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (13)

Aggarwal B, Liao M, Allegrante JP, Mosca L. Low social support level is associated with non-adherence to diet at 1 year in the Family Intervention Trial for Heart Health (FIT Heart). J Nutr Educ Behav. 2010 Nov-Dec;42(6):380-8. doi: 10.1016/j.jneb.2009.08 — View Citation

Aggarwal B, Liao M, Christian A, Mosca L. Influence of caregiving on lifestyle and psychosocial risk factors among family members of patients hospitalized with cardiovascular disease. J Gen Intern Med. 2009 Jan;24(1):93-8. doi: 10.1007/s11606-008-0852-1. — View Citation

Aggarwal B, Liao M, Mosca L. Predictors of physical activity at 1 year in a randomized controlled trial of family members of patients with cardiovascular disease. J Cardiovasc Nurs. 2010 Nov-Dec;25(6):444-9. doi: 10.1097/JCN.0b013e3181defd3e. — View Citation

Edelman DJ, Gao Q, Mosca L. Predictors and barriers to timely medical follow-up after cardiovascular disease risk factor screening according to race/ethnicity. J Natl Med Assoc. 2008 May;100(5):534-9. — View Citation

Fischer Aggarwal BA, Liao M, Mosca L. Physical activity as a potential mechanism through which social support may reduce cardiovascular disease risk. J Cardiovasc Nurs. 2008 Mar-Apr;23(2):90-6. doi: 10.1097/01.JCN.0000305074.43775.d8. — View Citation

Mochari H, Gao Q, Mosca L. Validation of the MEDFICTS dietary assessment questionnaire in a diverse population. J Am Diet Assoc. 2008 May;108(5):817-22. doi: 10.1016/j.jada.2008.02.021. — View Citation

Mochari H, Grbic JT, Mosca L. Usefulness of self-reported periodontal disease to identify individuals with elevated inflammatory markers at risk of cardiovascular disease. Am J Cardiol. 2008 Dec 1;102(11):1509-13. doi: 10.1016/j.amjcard.2008.07.047. Epub — View Citation

Mochari-Greenberger H, Mosca L. Caregiver burden and nonachievement of healthy lifestyle behaviors among family caregivers of cardiovascular disease patients. Am J Health Promot. 2012 Nov-Dec;27(2):84-9. doi: 10.4278/ajhp.110606-QUAN-241. — View Citation

Mochari-Greenberger H, Terry MB, Mosca L. Does stage of change modify the effectiveness of an educational intervention to improve diet among family members of hospitalized cardiovascular disease patients? J Am Diet Assoc. 2010 Jul;110(7):1027-35. doi: 10. — View Citation

Mochari-Greenberger H, Terry MB, Mosca L. Sex, age, and race/ethnicity do not modify the effectiveness of a diet intervention among family members of hospitalized cardiovascular disease patients. J Nutr Educ Behav. 2011 Sep-Oct;43(5):366-73. doi: 10.1016/ — View Citation

Mosca L, Mochari H, Liao M, Christian AH, Edelman DJ, Aggarwal B, Oz MC. A novel family-based intervention trial to improve heart health: FIT Heart: results of a randomized controlled trial. Circ Cardiovasc Qual Outcomes. 2008 Nov;1(2):98-106. doi: 10.116 — View Citation

Nawathe AC, Glied SA, Weintraub WS, Mosca LJ. The effect of a cardiovascular educational intervention on healthcare utilization and costs. Am J Manag Care. 2010 May;16(5):339-46. — View Citation

Parikh P, Mochari H, Mosca L. Clinical utility of a fingerstick technology to identify individuals with abnormal blood lipids and high-sensitivity C-reactive protein levels. Am J Health Promot. 2009 Mar-Apr;23(4):279-82. doi: 10.4278/ajhp.071221140. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent reduction in low-density lipoprotein (LDL) cholesterol levels in the special intervention group versus the control group		Measured at Year 1	No
Secondary	Mean percent change in high density lipoprotein (HDL) cholesterol levels in the special intervention group versus the control group		Measured at Year 1	No
Secondary	Attainment of the Therapeutic Lifestyle Change (TLC) diet		Measured at Year 1	No
Secondary	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	No
Secondary	Cost effectiveness of the personalized educational program to reduce LDL cholesterol levels and cost per life saved		Measured at Year 1	No
Secondary	Impact of hsCRP beyond traditional risk factors on attainment of prevention goals		Measured at Year 1	No