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Heartmatters Challenge - First Responders

Heartmatters Challenge - First Responders

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03322046
Acronym
HMC-FR
Enrollment
185
Registered
2017-10-26
Start date
2013-10-08
Completion date
2015-01-08
Last updated
2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

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

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.

Interventions

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.

Sponsors

Heart Fit for Duty, LLC
CollaboratorUNKNOWN
Boston Heart Diagnostics
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Weight loss12 monthsChange in weight from baseline measurement
Reduction in waist circumference12 monthsChange in waist circumference from baseline measurement
Increase in large HDL subparticles12 monthsChange in concentration of large HDL particles measured by 2Dimensional gel electrophoresis

Secondary

MeasureTime frameDescription
Improvements in blood based markers of CVD risk12 monthsMarkers involved in lipid metabolism, inflammation and metabolics

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026