Clinical trial NCT03482427: Healthy Heart Score Intervention In the Primary Care Setting
Official title: Assessing the Healthy Heart Score Intervention In the Primary Care Setting as a Primordial Prevention Tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: OhioHealth
First posted: 2018-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will test our intervention compared to usual care (control)
Primary purpose: PREVENTION

Brief 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).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older, No cardiovascular diagnosis, Body Mass Index \> 25 and/or having at least one of the following clinical risk factors: elevated blood pressure, pre-high cholesterol, pre-diabetes but not currently taking medications for the previous conditions.

Exclusion Criteria:

* Those not meeting the inclusion criteria and women who are pregnant or planning to get pregnant.

Primary outcomes:
measure: Changes in the overall Healthy Heart Score risk score
timeFrame: 12-weeks
measure: Changes in the overall composite of diet
timeFrame: 12-weeks
measure: Changes in fruit and vegetables intake
timeFrame: 12-weeks
measure: Changes in red and processed meats intake
timeFrame: 12-weeks
measure: Changes in sugar and sweetened beverages
timeFrame: 12-weeks
measure: Changes in nut consumption
timeFrame: 12-weeks
measure: changes in alcohol consumption
timeFrame: 12-weeks
measure: changes in cereal fiber
timeFrame: 12-weeks
measure: changes in body mass index
timeFrame: 12-weeks
measure: Changes in physical activity
timeFrame: 12-weeks
Secondary outcomes:
measure: Changes in total cholesterol levels
timeFrame: 12-weeks
measure: Changes in triglycerides levels
timeFrame: 12-weeks
measure: Changes in Low Density Protein levels
timeFrame: 12-weeks
measure: Changes in High Density Protein levels
timeFrame: 12-weeks
measure: Changes in Hemoglobin glycosylated levels
timeFrame: 12- weeks
measure: Changes in systolic blood pressure
timeFrame: 12-weeks
measure: Changes in diastolic blood pressure
timeFrame: 12-weeks
measure: changes in percentage of body fat
timeFrame: 12-weeks
measure: changes in body weight
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Dublin
country: United States
facility: OhioHealth Dublin Methodist Hospital
state: Ohio
Study officials:
affiliation: Ohio University
name: Mercedes Sotos Prieto, PhD
role: PRINCIPAL_INVESTIGATOR
References: