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| Name | Class |
|---|---|
| Heart Fit for Duty, LLC | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in blood based markers of CVD risk | Markers involved in lipid metabolism, inflammation and metabolics | 12 months |
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Inclusion Criteria:
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
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:
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First responders: fire fighters, police officers, EMT personnel
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| Name | Affiliation | Role |
|---|---|---|
| Michael Dansinger, MD | Boston Heart Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Heart Diagnostics | Framingham | Massachusetts | 01702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12637338 | Result | 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. | |
| 15388521 | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Serum, plasma
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| 17377158 | 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. |
| 18927545 | 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. |
| 22772954 | 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. |
| 20616715 | 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. |
| 16286523 | 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. |
| 30475306 | Derived | 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. |