Heartmatters Challenge - First Responders

NCT03322046 | Completed

• 1 other identifier: CA-13-002
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Keywords

Therapeutic Lifestyle Change; Cardiovascular Disease; First Responders; Firefighters; CVD

Outcome Measures

Primary Outcomes (3)

• Weight loss

  Change in weight from baseline measurement

  12 months

• Reduction in waist circumference

  Change in waist circumference from baseline measurement

  12 months

• Increase in large HDL subparticles

  Change in concentration of large HDL particles measured by 2Dimensional gel electrophoresis

  12 months

Secondary Outcomes (1)

• Improvements in blood based markers of CVD risk

  12 months

Study Arms (2)

Therapeutic Lifestyle Change (TLC) Intervention Group

TLC group received CVD risk lecture, enrolled in lifestyle program, received follow-up visits from team practitioner after each blood draw, access to food journaling portal for 12 month period, telephonic coaching

Behavioral: Lifestyle Program

Control Group

Control group received CVD risk lecture, then baseline, 3, 6, 12 month blood draws and 3 day food journals prior to each blood draw.

Interventions

Lifestyle Program BEHAVIORAL

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.

Therapeutic Lifestyle Change (TLC) Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

First responders: fire fighters, police officers, EMT personnel

You may qualify if:

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

You may not qualify if:

• No insulin-requiring diabetes
• No pregnancy or plans to get pregnant in next 12 months
• Unable or unwilling to follow protocol
• Unavailable for duration of study
• Planning to change jobs during study term

Sponsors & Collaborators

• Boston Heart Diagnostics: lead
• Heart Fit for Duty, LLC: collaborator

Study Sites (1)

Boston Heart Diagnostics

Framingham, Massachusetts, 01702, United States

Location

Related Publications (8)

• 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. doi: 10.1161/01.ATV.0000066133.32063.BB. Epub 2003 Mar 13.

  PMID: 12637338 RESULT

• 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. 2004 Nov;24(11):2181-7. doi: 10.1161/01.ATV.0000146325.93749.a8. Epub 2004 Sep 23.

  PMID: 15388521 RESULT

• 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. doi: 10.1056/NEJMoa060357.

  PMID: 17377158 RESULT

• 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.

  PMID: 18927545 RESULT

• 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.

  PMID: 22772954 RESULT

• 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.

  PMID: 20616715 RESULT

• 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. doi: 10.1038/oby.2005.214.

  PMID: 16286523 RESULT

• Gill R, Superko HR, McCarthy MM, Jack K, Jones B, Ghosh D, Richards S, Gleason JA, Williams PT, Dansinger M. Cardiovascular Risk Factor Reduction in First Responders Resulting From an Individualized Lifestyle and Blood Test Program: A Randomized Controlled Trial. J Occup Environ Med. 2019 Mar;61(3):183-189. doi: 10.1097/JOM.0000000000001490.

  PMID: 30475306 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Michael Dansinger, MD

  Boston Heart Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 26, 2017
• Study Start: October 8, 2013
• Primary Completion: November 20, 2014
• Study Completion: January 8, 2015
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (1)