Clinical Trials Directory

Trials / Completed

CompletedNCT03322046

Heartmatters Challenge - First Responders

Status
Completed
Phase
Study type
Observational
Enrollment
185 (actual)
Sponsor
Boston Heart Diagnostics · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALLifestyle Program4 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.

Timeline

Start date
2013-10-08
Primary completion
2014-11-20
Completion
2015-01-08
First posted
2017-10-26
Last updated
2017-10-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03322046. Inclusion in this directory is not an endorsement.