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OpenTrials
Completed

NCT Number: NCT03322046

Heartmatters Challenge - First Responders

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Heart Diagnostics

Framingham, Massachusetts, 01702, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Weight loss

    Time frame: 12 months

    Change in weight from baseline measurement

  2. Reduction in waist circumference

    Time frame: 12 months

    Change in waist circumference from baseline measurement

  3. Increase in large HDL subparticles

    Time frame: 12 months

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

Secondary outcomes

  1. Improvements in blood based markers of CVD risk

    Time frame: 12 months

    Markers involved in lipid metabolism, inflammation and metabolics

Sponsors and collaborators

Lead sponsor

Boston Heart Diagnostics

Industry

Collaborators

  • Heart Fit for Duty, LLC

Registry information

Acronym: HMC-FR

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Oct 26, 2017
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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