Clinical trial NCT03322046: Heartmatters Challenge - First Responders
Official title: Heartmatters Challenge - First Responders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Therapeutic Lifestyle Change
Cardiovascular Disease
First Responders
Firefighters
CVD
Lead sponsor: Boston Heart Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Heart Fit for Duty, LLC
First posted: 2017-10-26
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: First responders: fire fighters, police officers, EMT personnel

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.

Detailed 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.

Eligibility criteria: 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).

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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

Primary outcomes:
measure: Weight loss
timeFrame: 12 months
measure: Reduction in waist circumference
timeFrame: 12 months
measure: Increase in large HDL subparticles
timeFrame: 12 months
Secondary outcomes:
measure: Improvements in blood based markers of CVD risk
timeFrame: 12 months
Other outcomes:
Locations:
city: Framingham
country: United States
facility: Boston Heart Diagnostics
state: Massachusetts
Study officials:
affiliation: Boston Heart Diagnostics
name: Michael Dansinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. 2004 Nov;24(11):2181-7. doi: 10.1161/01.ATV.0000146325.93749.a8. Epub 2004 Sep 23.
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. doi: 10.1056/NEJMoa060357.
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.
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.
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.
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. doi: 10.1038/oby.2005.214.
citation: 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.