Heartmatters Challenge - First Responders (HMC-FR)

Boston Heart Diagnostics

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Lifestyle Program

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03322046

CA-13-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

185 participants in 2 patient groups

Therapeutic Lifestyle Change (TLC) Intervention Group

Description:

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

Treatment:

Behavioral: Lifestyle Program

Control Group

Description:

Control group received CVD risk lecture, then baseline, 3, 6, 12 month blood draws and 3 day food journals prior to each blood draw.