Heartmatters Challenge - First Responders (HMC-FR)

October 24, 2017 updated by: Boston Heart Diagnostics
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702
        • Boston Heart Diagnostics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

First responders: fire fighters, police officers, EMT personnel

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Behavioral: Lifestyle Program
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 12 months
Change in weight from baseline measurement
12 months
Reduction in waist circumference
Time Frame: 12 months
Change in waist circumference from baseline measurement
12 months
Increase in large HDL subparticles
Time Frame: 12 months
Change in concentration of large HDL particles measured by 2Dimensional gel electrophoresis
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvements in blood based markers of CVD risk
Time Frame: 12 months
Markers involved in lipid metabolism, inflammation and metabolics
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Heart Diagnostics

Collaborators

Heart Fit for Duty, LLC

Investigators

  • Principal Investigator: Michael Dansinger, MD, Boston Heart Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2013

Primary Completion (Actual)

November 20, 2014

Study Completion (Actual)

January 8, 2015

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA-13-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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