Heartmatters Challenge - First Responders

Study Overview
=================
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.

Official Title
-----------------
Heartmatters Challenge - First Responders

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Program


Participation Criteria
=================
Eligibility Criteria
-----------------
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). - 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Therapeutic Lifestyle Change (TLC) Intervention Group<br>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<br>* 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.<br>|
| Control Group<br>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 | Change in weight from baseline measurement | 12 months | 
| Reduction in waist circumference | Change in waist circumference from baseline measurement | 12 months | 
| Increase in large HDL subparticles | 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 | Markers involved in lipid metabolism, inflammation and metabolics | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CVD, Therapeutic Lifestyle Change, Cardiovascular Disease, First Responders, Firefighters