Assessing the Healthy Heart Score Intervention In the Primary Care Setting as a Primordial Prevention Tool
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Ohio University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Changes in the overall Healthy Heart Score risk score
- Last Updated
- 8 years ago
Overview
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).
Investigators
Mercedes Sotos Prieto, PhD
Assistant Professor
Ohio University
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.
Outcomes
Primary Outcomes
Changes in the overall Healthy Heart Score risk score
Time Frame: 12-weeks
The Healthy Heart Score is a lifestyle-based risk tool that estimates 20-year CVD risk (https://healthyheartscore.sph.harvard.edu/) This gender-specific algorithm has been published (DOI: 10.1161/JAHA.114.000954): 20-year CVD risk (%) "Healthy Heart Score" = \[1 - 0. 9660 (exp \[W- 6.57301)\] × 100% where W= 0.10820 x age + 0.15285 (if past smoker) + 0.90138 (if current smoker) + 0.04676 × BMI - 0.01923 × grams/d of alcohol + 0.0004 × (grams/d of alcohol)2- 0.029251 × hours/week of physical activity - 0.05113 × diet score\* 20-year CVD risk (%) "Healthy Heart Score" = \[1 - 0. 96368 (exp \[W-7.2437)\] × 100% where W= 0.13580 x age- 0.0005 x (age)2 + 0.06979 (if past smoker) + 0.42305 (if current smoker) +0.07424 × BMI - 0.00898 × grams/d of alcohol + 0.0001 × (grams/d of alcohol)2- 0.01755 × hours/week of physical activity - 0.06691 × diet score
Changes in the overall composite of diet
Time Frame: 12-weeks
women: Diet score = (0.03626 × grams/d of cereal fiber + 0.18283 \[if fruits + vegetables ≥3 servings/d\] + 0.14522 \[if nuts 0.1-1 servings/d + 0.2444 \[if nuts \>1 servings/d\]- 0.14631 × servings/d of sugar-sweetened beverages - 0.15624 × servings/d of red and processed meats)\*10 Women: Diet score = (0.03626 × grams/d of cereal fiber + 0.18283 \[if fruits + vegetables ≥3 servings/d\] + 0.14522 \[if nuts 0.1-1 servings/d + 0.2444 \[if nuts \>1 servings/d\]- 0.14631 × servings/d of sugar-sweetened beverages - 0.15624 × servings/d of red and processed meats)\*10. Men: where W= 0.13580 x age- 0.0005 x (age)2 + 0.06979 (if past smoker) + 0.42305 (if current smoker) +0.07424 × BMI - 0.00898 × grams/d of alcohol + 0.0001 × (grams/d of alcohol)2- 0.01755 × hours/week of physical activity - 0.06691 × diet score\*
Changes in fruit and vegetables intake
Time Frame: 12-weeks
servings/day
Changes in red and processed meats intake
Time Frame: 12-weeks
servings/week
Changes in sugar and sweetened beverages
Time Frame: 12-weeks
servings/week
Changes in nut consumption
Time Frame: 12-weeks
servings week
changes in alcohol consumption
Time Frame: 12-weeks
g/day
changes in cereal fiber
Time Frame: 12-weeks
g/day
changes in body mass index
Time Frame: 12-weeks
kg/m2
Changes in physical activity
Time Frame: 12-weeks
hours per week
Secondary Outcomes
- Changes in diastolic blood pressure(12-weeks)
- changes in percentage of body fat(12-weeks)
- changes in body weight(12-weeks)
- Changes in total cholesterol levels(12-weeks)
- Changes in triglycerides levels(12-weeks)
- Changes in Low Density Protein levels(12-weeks)
- Changes in High Density Protein levels(12-weeks)
- Changes in Hemoglobin glycosylated levels(12- weeks)
- Changes in systolic blood pressure(12-weeks)