AzTrials
AzTrials

Cardiovascular DiseasesFIT-HeartNCT00728637

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

A study testing Family Passport to Heart Health Program and General Educational Materials in people with Cardiovascular Diseases and Heart Diseases, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases, Heart Diseases
What is being tested?
Family Passport to Heart Health Program and General Educational Materials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
501 participants
Where
1 siteUnited States
Study dates
Jan 2005to Jun 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
Family Passport to Heart Health Program, General Educational Materials
Keywords
Prevention
Medical subject headings
Cardiovascular Diseases, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Passport to Heart Health ProgramBehavioural

    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 MaterialsBehavioural

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

Study groups in NCT00728637
Study groupRoleWhat they receive
1ExperimentalParticipants took part in the Family Passport to Heart Health Program.
Receives: Behavioral: Family Passport to Heart Health Program
2Active comparatorParticipants took part in a control group.
Receives: Behavioral: General Educational Materials

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Measured at Year 1

Secondary outcomes (5)

  1. Mean percent change in high density lipoprotein (HDL) cholesterol levels in the special intervention group versus the control group

    Measured: Measured at Year 1

  2. Attainment of the Therapeutic Lifestyle Change (TLC) diet

    Measured: Measured at Year 1

  3. 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: Measured at Year 1

  4. Cost effectiveness of the personalized educational program to reduce LDL cholesterol levels and cost per life saved

    Measured: Measured at Year 1

  5. Impact of hsCRP beyond traditional risk factors on attainment of prevention goals

    Measured: Measured at Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2008 (estimated)
  2. Study startJan 2005
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00728637
Sponsor's protocol ID
AAAA5856
Other IDs
R01HL075101
Acronym
FIT-Heart
Status last verified
May 2013
First submitted
4 Aug 2008
Last updated
15 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18507205

  • 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.

    PubMed 18442505

  • 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.

    PubMed 18382248

  • 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.

    PubMed 20856131

  • 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.

    PubMed 20696617

  • 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.

    PubMed 20031796

  • 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.

    PubMed 18998190

  • 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.

    PubMed 23113777

  • 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.

    PubMed 21906549

  • 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.

    PubMed 20630159

  • 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.

    PubMed 19288850

  • 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.

    PubMed 19026305

  • 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.

    PubMed 20469954

Questions about this trial

What is this clinical trial studying?

A study testing Family Passport to Heart Health Program and General Educational Materials in people with Cardiovascular Diseases and Heart Diseases, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00728637, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in