Heartmatters Challenge - First Responders

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: Lifestyle Program

• Registration Number: NCT03322046
• Lead Sponsor: Boston Heart Diagnostics

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.

Study Timeline

• Study Start: 2013-10-08
• Primary Completion: 2014-11-20
• Study Completion: 2015-01-08
• Status Verified: 2017-10
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-24
• Last Update Submitted: 2017-10-24
• Study First Posted: 2017-10-26
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Therapeutic Lifestyle Change (TLC) Intervention Group	Lifestyle Program	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvements in blood based markers of CVD risk	12 months	Markers involved in lipid metabolism, inflammation and metabolics

Trial Locations

Locations (1)

Boston Heart Diagnostics; 🇺🇸 Framingham, Massachusetts, United States