Heartmatters Challenge - First Responders

Cardiovascular Diseases Clinical Trial

— HMC-FR  

Official title:

Heartmatters Challenge - First Responders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322046
• Other study ID #: CA-13-002
• Status: Completed
• Phase: N/A
• First received: October 18, 2017
• Last updated: October 24, 2017
• Start date: October 8, 2013
• Est. completion date: January 8, 2015

Study information

• Verified date: October 2017
• Source: Boston Heart Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this protocol is to observe whether providing the first responder population with a multi-tiered therapeutic lifestyle modification program, including regular blood testing, diet and telephonic lifestyle coaching, daily food journaling using web-based tools and smartphone apps can lead to positive changes in behavior, resulting in improvements in blood based markers of risk of cardiovascular disease (CVD) as well as improvements in weight and waist circumference.

Description:

A cluster randomization of first responder communities in the metro Boston and metro Phoenix areas was performed. First responders attended a one hour lecture on the specific risks of CVD in that population and then qualified intervention candidates were enrolled into a lifestyle program, consisting of telephone-based coaching sessions with a registered dietitian and an online/app based food journaling program. Both groups had blood test draws at baseline, 3, 6 and 12 months. The intervention group met with the team practitioner to review results and progress after each blood draw. The test panel comprised blood-based markers of CVD risk associated with lipid metabolism, metabolics, inflammation and basic liver and kidney function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: January 8, 2015
• Est. primary completion date: November 20, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Low apolipoprotein A-1 (apoA-1) levels in the very large alpha-1 HDL particle (<20 mg/dL for men, <30 mg/dL for women) OR increased waist size (at least 40 inches for men or 35 inches for women).

2. Internet access

3. 14 day food log completed prior to initiating the study intervention (or 3-day food log for the control group).

Exclusion Criteria:

1. No insulin-requiring diabetes

2. No pregnancy or plans to get pregnant in next 12 months

3. Unable or unwilling to follow protocol

4. Unavailable for duration of study

5. Planning to change jobs during study term

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Lifestyle Program
4 elements: 1) Laboratory test results with diagnostic report describing results, 2) Lifestyle plan generated in online portal with personalized nutritional information based on combination of laboratory results and personal preferences, 3) online or smartphone food journaling application, 4) telephone based lifestyle coaching with Registered Dietitian.

Locations

Country	Name	City	State
United States	Boston Heart Diagnostics	Framingham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Heart Diagnostics	Heart Fit for Duty, LLC

Country where clinical trial is conducted

United States, 

References & Publications (7)

Asztalos BF, Batista M, Horvath KV, Cox CE, Dallal GE, Morse JS, Brown GB, Schaefer EJ. Change in alpha1 HDL concentration predicts progression in coronary artery stenosis. Arterioscler Thromb Vasc Biol. 2003 May 1;23(5):847-52. Epub 2003 Mar 13. — View Citation

Asztalos BF, Cupples LA, Demissie S, Horvath KV, Cox CE, Batista MC, Schaefer EJ. High-density lipoprotein subpopulation profile and coronary heart disease prevalence in male participants of the Framingham Offspring Study. Arterioscler Thromb Vasc Biol. 2 — View Citation

Kales SN, Soteriades ES, Christophi CA, Christiani DC. Emergency duties and deaths from heart disease among firefighters in the United States. N Engl J Med. 2007 Mar 22;356(12):1207-15. — View Citation

Kales SN, Tsismenakis AJ, Zhang C, Soteriades ES. Blood pressure in firefighters, police officers, and other emergency responders. Am J Hypertens. 2009 Jan;22(1):11-20. doi: 10.1038/ajh.2008.296. Epub 2008 Oct 16. Review. — View Citation

Poston WS, Jitnarin N, Haddock CK, Jahnke SA, Tuley BC. The impact of surveillance on weight change and predictors of change in a population-based firefighter cohort. J Occup Environ Med. 2012 Aug;54(8):961-8. doi: 10.1097/JOM.0b013e31825296e0. — View Citation

Schaefer EJ, Santos RD, Asztalos BF. Marked HDL deficiency and premature coronary heart disease. Curr Opin Lipidol. 2010 Aug;21(4):289-97. doi: 10.1097/MOL.0b013e32833c1ef6. Review. — View Citation

Soteriades ES, Hauser R, Kawachi I, Liarokapis D, Christiani DC, Kales SN. Obesity and cardiovascular disease risk factors in firefighters: a prospective cohort study. Obes Res. 2005 Oct;13(10):1756-63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Change in weight from baseline measurement	12 months
Primary	Reduction in waist circumference	Change in waist circumference from baseline measurement	12 months
Primary	Increase in large HDL subparticles	Change in concentration of large HDL particles measured by 2Dimensional gel electrophoresis	12 months
Secondary	Improvements in blood based markers of CVD risk	Markers involved in lipid metabolism, inflammation and metabolics	12 months