NCT03482427

Healthy Heart Score Intervention In the Primary Care Setting

Assessing the Healthy Heart Score Intervention In the Primary Care Setting as a Primordial Prevention Tool

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ohio University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this pilot study, the investigators will assess the clinical utility and feasibility of the Healthy Heart Score in the primary clinical care setting for the primordial prevention of cardiovascular disease. The investigators will conduct a randomized clinical trial to test the lifestyle intervention based on the Healthy Heart Score compared to usual care. The aim is to include 100 participants (50 in each group). Each participant will complete 2 visits (initial and a follow up visit after 12 weeks).

Detailed description

Created by the Harvard T.H Chan School of Public Health, the Healthy Heart Score is a previously validated online risk calculator that determines the 20-year Cardiovascular Disease ) risk based on 9 modifiable lifestyle factors including; smoking habits, body mass index, physical activity, alcohol consumption, fruit and vegetables intake, cereal fiber, nuts, sugar-sweetened beverages, and red meat, and processed meats consumption. In this pilot study, the investigators will assess the clinical utility and feasibility of the Healthy Heart Score in the primary clinical care setting for the primordial prevention of cardiovascular disease. The investigators will conduct a clinical trial to test our intervention compared to usual care. The investigators will conduct a randomized clinical trial to test the lifestyle intervention based on the Healthy Heart Score compared to usual care. The aim is to include 100 participants (50 in each group). Each participant will complete 2 visits (initial and a follow up visit after 12 weeks).

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Healthy Heart Score	Educational materials based on each component of the Healthy Heart Score and other lifestyle behaviors will be provided to the participants that include the following topics: Fruit and vegetable consumption, Whole grain consumption/ limiting refined grains, Healthy protein choices, Healthy dietary fats, Limiting Sugar-sweetened beverages, Importance of physical activity, Proper hydration, Stress management, Adequate Sleep, Smoking Cessation, Weekly menu example, Recipe Cards following the Mediterranean diet principals, Interactive weekly checklist to encourage participants to meet their weekly goals for consumption of fruits, vegetable, nuts and seeds. Participants will receive a check-in email or phone 6 weeks after the baseline visit. A Registered Dietitian is also available to speak with patients.

Timeline

• Start date: 2018-03-19
• Primary completion: 2018-12-30
• Completion: 2019-04-30
• First posted: 2018-03-29
• Last updated: 2018-03-29

Locations

1 site across 1 country: United States