HMC-FR: Heartmatters Challenge - First Responders

Sponsor

Boston Heart Diagnostics (Industry)

Overall Status

Completed

CT.gov ID

NCT03322046

Collaborator

Heart Fit for Duty, LLC (Other)

185

Enrollment

Location

Actual Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Behavioral: Lifestyle Program

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 Design

Study Type:

Observational

Actual Enrollment :

185 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Heartmatters Challenge - First Responders

Actual Study Start Date :

Oct 8, 2013

Actual Primary Completion Date :

Nov 20, 2014

Actual Study Completion Date :

Jan 8, 2015

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Weight loss [12 months]
Change in weight from baseline measurement
Reduction in waist circumference [12 months]
Change in waist circumference from baseline measurement
Increase in large HDL subparticles [12 months]
Change in concentration of large HDL particles measured by 2Dimensional gel electrophoresis

Secondary Outcome Measures

Improvements in blood based markers of CVD risk [12 months]
Markers involved in lipid metabolism, inflammation and metabolics

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).