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Cardiovascular DiseasesHMC-FRNCT03322046

Heartmatters Challenge - First Responders

An observational study of Cardiovascular Diseases, run by Boston Heart Diagnostics 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
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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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Lifestyle Program
How many people
185 participants
Where
1 siteUnited States
Study dates
8 Oct 2013to 8 Jan 2015
Phase
Observational
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: First responders: fire fighters, police officers, EMT personnel

Who may be able to join

  • 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).
  • -

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Heart Diagnostics

    Framingham, Massachusetts, 01702

Other trials in United States

About this study

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.

Read the 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.

Being tested
Lifestyle Program
Keywords
Therapeutic Lifestyle Change, Cardiovascular Disease, First Responders, Firefighters, CVD
Medical subject headings
Cardiovascular Diseases

What participants receive

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

  • Lifestyle ProgramBehavioural

    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.

Study groups in NCT03322046
Study groupRoleWhat they receive
Therapeutic Lifestyle Change (TLC) Intervention GroupTLC 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
Receives: Behavioral: Lifestyle Program
Control GroupControl group received CVD risk lecture, then baseline, 3, 6, 12 month blood draws and 3 day food journals prior to each blood draw.

What is being measured

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

  1. Weight loss

    Change in weight from baseline measurement

    Measured: 12 months

  2. Reduction in waist circumference

    Change in waist circumference from baseline measurement

    Measured: 12 months

  3. Increase in large HDL subparticles

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

    Measured: 12 months

Secondary outcomes (1)

  1. Improvements in blood based markers of CVD risk

    Markers involved in lipid metabolism, inflammation and metabolics

    Measured: 12 months

Timeline

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

  1. First posted26 Oct 2017
  2. Study start8 Oct 2013
  3. Primary completion20 Nov 2014
  4. Study completion8 Jan 2015

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03322046
Sponsor's protocol ID
CA-13-002
Acronym
HMC-FR
Status last verified
Oct 2017
First submitted
18 Oct 2017
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 12637338

  • 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.

    PubMed 15388521

  • 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.

    PubMed 17377158

  • 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.

    PubMed 18927545

  • 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.

    PubMed 22772954

  • 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.

    PubMed 20616715

  • 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.

    PubMed 16286523

  • 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.

    PubMed 30475306

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, run by Boston Heart Diagnostics 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 26 Oct 2017. 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?

Weight loss (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT03322046, which also lists 8 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 26 Oct 2017; AzTrials last refreshed its copy on 27 Oct 2026.

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