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

NCT00728637 | Completed DMC

• 2 other identifiers: AAAA5856R01HL075101
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Heart Diseases

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

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

  Measured at Year 1

Secondary Outcomes (5)

• 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

Study Arms (2)

1

EXPERIMENTAL

Participants took part in the Family Passport to Heart Health Program.

Behavioral: Family Passport to Heart Health Program

2

ACTIVE COMPARATOR

Participants took part in a control group.

Behavioral: General Educational Materials

Interventions

Family Passport to Heart Health Program BEHAVIORAL

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.

1

General Educational Materials BEHAVIORAL

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

2

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (13)

• 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. doi: 10.1016/s0027-9684(15)31299-2.

  PMID: 18507205 RESULT

• 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.

  PMID: 18442505 RESULT

• 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.

  PMID: 18382248 RESULT

• 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.

  PMID: 20856131 RESULT

• 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.2009.08.006. Epub 2010 Aug 8.

  PMID: 20696617 RESULT

• 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: 10.1161/CIRCOUTCOMES.108.825786. Epub 2008 Nov 12.

  PMID: 20031796 RESULT

• 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. Epub 2008 Nov 8.

  PMID: 18998190 RESULT

• 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.

  PMID: 23113777 RESULT

• 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/j.jneb.2011.01.014.

  PMID: 21906549 RESULT

• 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: 10.1016/j.jada.2010.04.012.

  PMID: 20630159 RESULT

• 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.

  PMID: 19288850 RESULT

• 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 2008 Sep 15.

  PMID: 19026305 RESULT

• 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.

  PMID: 20469954 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases

Study Officials

• Lori Mosca, MD, MPH, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Columbia University.

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 6, 2008
• Study Start: January 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

US (1)